GSK & 3 leading institutions form EU consortium

A new European consortium has been formed including GSK and three leading research institutions, University of Oxford, Centre Hospitalier Universitaire Vaudois in Lausanne and the Bernhard-Nocht Institute, to help further advance development of a candidate vaccine against Ebola, which is being co-developed by GSK and the US National Institutes of Health (NIH).

The consortium is backed by funding of €15.1 million from the European Commission Directorate General for Research and Innovation as part of its dedicated Horizon 2020 programme supporting research into treatments and vaccines for Ebola. The consortium also expects to receive an additional €1.4 million from the Swiss government.

The funding is already helping to implement an ongoing trial of an Ebola candidate vaccine being carried out in 120 healthy adult volunteers in Lausanne, Switzerland. If the safety and immunogenicity data from this and other ongoing phase 1 trials are encouraging, the EC funding will enable the consortium to begin larger phase 2 trials in Africa, which could start as early as January 2015.

Cerus' Intercept Blood System for plasma receives US FDA approval

The US Food and Drug Administration (FDA) has approved Cerus Corporation's Intercept Blood System for plasma. The Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.

The Intercept Blood System inactivates a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.

While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in plasma components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.

"We believe this approval to be a pivotal step toward giving US blood centres a proactive approach for protecting the plasma supply," said William ‘Obi' Greenman, Cerus’ president and chief executive officer. "Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the US approval for Intercept plasma, and our continued work with FDA on reaching an approval decision for the Intercept Blood System for platelets."

PYRIDINES

PYRIDINES

1. 2-AMINO-5-BROMO PYRIDINE [CASNO: 1072-97-5]
2. 2-AMINO-3, 5-DIBROMO PYRIDINE [CASNO: 35486-42-1]
3. 2-AMINO-5-NITRO PYRIDINE [CASNO: 3073-77-6]
4. 2-HYDROXY-5-NITRO PYRIDINE [CASNO: 5418-51-9]
5. 4-NITRO-2-PICOLINE N-OXIDE [CASNO: 5470-66-6]
6. 4-CYANO-2-PICOLINE
7. 3-CYANO-2-CHLORO-4-PICOLINE
8. 4-NITRO-3-PICOLINE
9. 2-BROMO PYRIDINE [CASNO: 109-04-6]
10. 2-HYDROXY-5-AMINO PYRIDINE [
11. 3-NITRO-4-PICOLINE
12. 4-BROMO-2-PICOLINE [CASNO: 22282-99-1]
13. 2-HYDROXY PYRIDINE [CASNO: 142-08-5]
14. 2-METHOXY PYRIDINE [CASNO: 1628-89-3]
15. 3-AMINO PYRIDINE [CASNO: 462-08-8]
16. 4-AMINO PYRIDINE CASNO: 504-24-5]
17. 3-CYANO PYRIDINE [CASNO: 100-54-9]
18. 4-CYANO PYRIDINE [CASNO: 100-48-1]
19. 2-HYDROXY-3, 5-DIBROMO PYRIDINE [CASNO: 13472-81-6]
20. 5-AMINO-3-PICOLINE
21. 2-CHLORO-5-NITRO PYRIDINE [CASNO: 4548-45-2]
22. 2, 5-DI BROMO PYRIDINE [CASNO: 624-28-2]
23. 2-CHLORO-3-NITRO-4-PICOLINE
24. 2, 6-DICLORO-3-NITRO PYRIDINE [CASNO: 16013-85-7]
25. 2-AMINO-6-METHOXY-3-NITRO PYRIDINE [CASNO: 
26. 2-CHLORO-6-METHOXY-3-NITRO PYRIDINE [CASNO: 38533-61-8]
27. 2-CHLORO-6-AMINO PYRIDINE 
28. 2-BROMO-6-CYANO PYRIDINE
29. 6-CYANO-2-PICOLINE
30. 2.AMINO-5-BORMO-3-NITRO PYRIDINE [CASNO: 6945-68-2]
31. 2, 3-DI AMINO PYRIDINE [CASNO: 452-58-4]
32. 3-NITRO-2-PICOLINE
33. 2-METHOXY-5-AMINOPYRIDINE [CASNO: 6628-77-9]
34. 3-BROMO PYRIDINE [CASNO: 626-55-1]
35. 3-HYDROXY PYRIDINE [CASNO: 109-00-2]
36. 2-PICOLINE N-OXIDE [CASNO: 931-19-1]
37. 4-PICOLINE N-OXIDE [CASNO: 1003-67-4]
38. 3-PICOLINE N-OXIDE [CASNO: 1003-73-2]
39. 4-NITRO PYRIDINE N-OXIDE [CASNO: 1124-33-0]
40. PYRIDINE N-OXIDE [CASNO: 694-59-7]

Merck Millipore hosts seminar on regulations and quality control

To apprise Indian pharmaceutical industry about the latest trends and developments concerning regulations in the pharmaceutical industry worldwide, Merck Millipore, the life science division of Merck, organised the third edition of ‘EMPROVE Seminar Series’ in Hyderabad. The theme of the seminar was ‘Risk Mitigation’, which addresses the current challenges faced by the industry.

Attended by over 200 invitees, topics in the seminar ranged from quality by design, Risk-based CMC development solutions presented by Ranjit Barshikar and FDA Inspectional Observations and Warning Letter Citations relating to quality control and assurance by Dr Hemant Mondkar.

The seminar was inaugurated by Tapan Ray, Former President- OPPI. In his inaugural address, he emphasised that it was high time for the industry to “walk the talk” in ethics, values and compliance. Merck Millipore’s panel of speakers addressed various facets of the current issues concerning regulations and shared their expertise with the audience.

This initiative, a service to the industry started by Merck Millipore in 2012, has drawn an ever increasing number of participants, because of its relevance and insights offered by the experts. The idea is to provide a platform for all its stakeholders to enhance their knowledge and keep abreast of latest trends and evolving regulatory agency compliance demands.

Vetter opens new representative office in Singapore

Vetter,  a premier contract development and manufacturing organization (CDMO), opens a new representative office in Singapore. The announcement was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

The new office will allow Vetter to take better advantage of the rapidly growing Asian healthcare market by increasing the presence of the company in this market. It will be staffed by Chervee Ho, Director Key Account Management Asia Pacific. Prior, the company’s Asian customers were handled by the German-based departments of key account management, project management and customer service. Ho will be responsible for supporting the German departments to better serve the existing customer base due to geographic and time proximity as well as the development of new markets.

DENGUE & EBOLA

Dengue fever and Ebola virus disease are two major epidemics that are  threatening millions of people in the world today with no effective remedies available to treat the patients. Dengue fever, the fastest growing tropical illness, currently affects at least 100 million people, according to the World Health Organization, although many doctors believe that because the disease is often misdiagnosed, the actual number of people affected could be three times more than what is estimated. Though most people survive the excruciatingly painful disease, more than 20,000 people do die from the disease every year with children the most affected. Dengue virus can cause flu-like symptoms, as well as bleeding gums, vomiting and severe abdominal pain.

The disease is transmitted by the bite of an Aedes mosquito infected with a dengue virus. The mosquito becomes infected when it bites a person with dengue virus in their blood. It can’t be spread directly from one person to another person. The Ebola virus disease, started in Guinea,  has since spread to Liberia and Sierra Leone in West Africa.

The ongoing epidemic is the most widespread in history and has caused significant mortality, with a reported fatality rate of 71%.  As of November 2014, the WHO and the governments of the affected countries have reported a total of 14,098 suspected cases and 5,489 deaths, though the WHO believes that this substantially understates the magnitude of the outbreak with true figures numbering three times as many cases as have been reported. The assistant director-general of the WHO warned in mid-October that there could be as many as 10,000 new EVD cases per week by December 2014. Almost all of the cases have occurred in the three initial countries.

Atmel introduces high-precision digital temperature sensors

Atmel Corporation, a global leader in microcontroller (MCU) and touch technology solutions, has launched the industry's first family of high-precision digital temperature sensors with the widest Vcc range from 1.7V to 5.5V. The new family delivers higher temperature accuracy and faster I2C bus communication speeds, and are available with integrated nonvolatile registers and serial EEPROM memory making them ideal for consumer, industrial, computer, and medical applications.

With the widest Vcc range in the industry, the new temperature sensor family allows customers to purchase one device to cover all their Vcc requirements in a variety of applications. Currently, digital temperature sensors on the market are available with a very limited Vcc range requiring customers to purchase multiple temperature sensors in their overall bill of materials (BOM) and utilizing multiple devices to cover the different voltage ranges across various applications. Atmel's new family of digital temperature sensors allows customers to select just one device to cover all Vcc requirements in various applications, reducing their overall BOM. The new family also delivers a higher accuracy rate at +/-0.5°C accuracy (typical) across the 0°C to +85°C temperature range across the entire wide voltage range (1.7V to 5.5V). The low voltage operation of the devices also reduce the overall power consumption in applications such as portable handheld consumer devices, enabling longer battery life.

Hospira introduces generic paricalcitol inj in US to treat

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, has introduced paricalcitol injection, a generic version of AbbVie's Zemplar. Hospira obtained US Food and Drug Administration (FDA) approval of paricalcitol on October 21 and launched the product November 1.

Hospira's paricalcitol - available in three multi-dose vial configurations - is approved for the prevention and treatment of secondary hyperparathyroidism associated with Stage 5 chronic kidney disease (CKD). Hyperparathyroidism contributes to the development of metabolic bone disease.

Sterile use of multi-dose vials can reduce waste because the vial's entire contents can be utilized over time, as opposed to single-dose vials, which require clinicians to discard the unused volume of solution after drawing up the patient's specific dose. The current branded drug offers only one of three sizes as a multi-dose configuration.

Novartis India net declines by 69% in Q2

Novartis India has registered lower net profit of Rs.14.04 crore for the second quarter ended September 2014 as against Rs.45.55 crore in the corresponding period of last year. Its net sales improved by 8.9 per cent to Rs.227.83 crore from Rs.209.18 crore. With lower net profit, its EPS declined to Rs.4.39 from Rs.14.25 in the last period.

Its pharmaceuticals sales improved by 13.1 per cent to Rs.155.24 crore from Rs.137.21 crore and tht of OTC improved by 25.9 per cent to Rs.42.21 crore from Rs.33.53 crore. However, its net sales of generics declined slightly to Rs.13.50 crore from Rs.14.09 crore. Further, sales of Animal Healthcare also declined to Rs.23.84 crore from Rs.29.09 crore

As a part of its global portfolio transformation, Novartis AG, Basel, Switzerland agreed on 22 April 2014 to divest its global Animal health Business to Eli Lilly and Co. Closing of this global transaction is subject to receipt of all applicable anti-trust and regulatory approvals, as well as the satisfaction or waiver (as applicable) of various other conditions. Today, Board of directors of Novartis India has approved the disposal of its animal health division for a consideration of Rs.86.68 crore to Elanco India Pvt Ltd (or another affiliate of Lilly) before July 22, 2015. 

AstraZeneca's once-daily Xigduo XR tablets approved in US

The US Food and Drug Administration has approved AstraZeneca's once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.

Xigduo XR combines two anti-hyperglycaemic agents with complementary mechanisms of action, dapagliflozin (trade name in the US, FARXIGA), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.

Xigduo XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated as an adjunct therapy to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

“The addition of Xigduo XR to our US diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca. “The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalised approach to disease management.”

Xigduo XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. Xigduo (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.

Marksans Pharma net jumps up by 56% to Rs. 31 cr

Marksans Pharma has posted impressive performance during the second quarter ended September 2014 and its consolidated net profit increased by 55.7 per cent to Rs. 31.16 crore from Rs. 20.01 crore in the similar period of last year. Its EBDITA also moved up by 71.8 per cent to Rs. 50.96 crore from Rs. 29.66 crore. EPS worked out to Rs. 0.82 as against Rs. 0.53 in the last period.

The company's consolidated net sales for the first six months ended September 2014 increased by 35.3 per cent to Rs. 413 crore from Rs. 305 crore and its net profit moved up by 46 per cent to Rs. 56.63 crore from Rs. 38.79 crore in the corresponding period of last year. Its formulations business in Europe increased by 43 per cent to Rs. 271.20 crore from Rs. 189.70 crore and its US & North America formulation revenue improved by 46.7 per cent to Rs. 76.46 crore. Its revenue in Australia and New Zealand touched to Rs. 41.10 crore.

Sanofi net moves up by 9% to € 2.7 bn in Q3

Sanofi, a French pharma giant, has posted satisfactory performance during the third quarter ended September 2014 and its net profit increased by 9.3 per cent to € 2,716 million from €2,484 million in the corresponding period of last year. Its net sales grew by 4.1 per cent to €8,781 million from €8,432 million. EPS improved to €1.47 from €1.36 in the last period. Its R&D expenditure declined by 3 per cent to €1,146 million reflecting lower spend on oncology.

Christopher A Viehbacher, CEO, said, “We are pleased with our performance in the third quarter. We achieved solid business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78 per cent of sales and grew 10 per cent. We have recently seen a more challenging US diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in phase III as well as the FDA approval of Cerdelga and the licensing of Afrezza.”

Mexichem swings to profit

Mexichem (Tlalnepantla, Mexico) swung to profit, reporting net income of $52.8 million during the third quarter compared with a net loss of $62.8 million in the same period last year, according to the company's latest unaudited results.

This increase was primarily due to the impact of discontinued operations in the fluorine chain on last year's results. The company's consolidated net income from continuing operations contracted 47% year-on-year (YOY) in the third quarter, to $47.3 million from $88.9 million one year prior.

Bio-based chemicals to attract $1 bn investment

The bio-based materials and chemicals industry is poised to attract nearly $1 billion in investment this year, led notably by later-stage funding rounds, according to Lux Research. The estimated $974 million investment represents a 28% increase from 2013, suggesting companies that endured the waves of economic disruption have gained maturity and regained investors’ confidence.

“Over the last two years, funding for bio-based materials and chemicals has shifted decisively toward later-stage rounds, reflecting the growing maturing of the industry and the shift from R&D to production,” said Meraldo Antonio, Lux Research Associate and the lead author of the report titled, ‘Dynamics of venture capital funding in the bio-based chemicals industry’

Octapharma adds track & trace solution to Werum's PAS-X at their Vienna site

Octapharma, one of the largest independent manufacturers of human protein products worldwide, has added the PAS-X Track & Trace Serialization Aggregation solution to Werum's PAS-X at their production site in Vienna.

Octapharma has been committed to patient care and medical innovation for over 30 years. Its core business is the development, production and sale of human proteins from human plasma and human cell-lines. Patients in over 100 countries are treated with products in the areas of haematology, immunotherapy and critical care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.

Octapharma employs strict in-process quality control systems to ensure traceability, providing the complete documentation of the origin of all plasma donations, their processing and distribution to countries worldwide. The company requires a flexible and stringently validated system for marking, identifying and tracking their products.

In a first step, PAS-X Track & Trace will be operated in the packaging area for the Chinese market. The serialization data provided by the Chinese authorities are loaded and the used data are reported back. PAS-X Track & Trace is interfaced to the existing PAS-X and exchanges order and stock data with the MES.

ndoco Remedies net jumps by 40% to Rs.22.41 cr in Q2

Indoco Remedies, a Rs.700 crore plus pharma major from Mumbai, has posted satisfactory performance during the second quarter ended September 2014 and its net profit moved up by 39.7 per cent to Rs.22.41 crore from Rs.16.04 crore in the corresponding period of last year. Its EBDITA also improved sharply by 73.9 per cent to Rs.49.19 crore from Rs.33.44 crore. The company's standalone net sales improved by 16.1 per cent to Rs.226.42 crore from Rs.195.05 crore. With higher profit, its EPS worked out to Rs.2.43 as compared to Rs.1.74 in the last period.

The company's domestic sales increased to Rs.144.69 crore from Rs.127.59 crore, a growth of 13.4 per cent and its international sales went up by 21.2 per cent to Rs.81.73 crore from Rs.67.46 crore. The company launched six new products in the domestic market. Indoco's European sales contributed 61.9 per cent and US sales 21.9 per cent to its international sales.

BIRAC invites fresh proposals from biotech companies

The Biotechnology Industry Research Assistance Council (BIRAC), under its advanced technology scheme, Biotechnology Industry Partnership Programme (BIPP), has invited fresh proposals from biotech companies for support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of Start-ups and SMEs in key areas of national importance and public good.

BIRAC, a not-for-profit public sector undertaking set up by Department of Biotechnology (DBT), is running this scheme to promote and nurture innovation research in biotech enterprises specially start-ups and SMEs. Major thrust of the programme is towards funding technologies which address a major national problem and/or involves high level of innovation. The proposals spanning across the spectrum of pre-proof-of-concept to validation of established technologies are considered for support in the form of grant and/or loan.

The scheme supports large, medium, small scale companies as well as start-up on cost sharing basis. It would push for high risk, discovery linked innovation and accelerated technology development. Varying models of grants, loans or grant plus loans will be made available under the scheme.  It will be one of the most enabling mechanisms to promote R&D in biotech industry and public private partnership programmes.

US FDA approves Konica Minolta's AeroDR XE wireless digital

Konica Minolta Medical Imaging, a world class provider and market leader in medical diagnostic primary imaging, has received the US Food and Drug Administration (FDA) clearance for its new AeroDR XE wireless digital radiography solution.

Healthcare providers in the demanding ER/Trauma rooms and ICU/CCU units need simple, reliable, and robust primary imaging solutions that deliver the information they need to make important patient care decisions quickly and confidently.

To address the needs of these fast-paced, extreme environments, Konica Minolta offers the simple yet powerful AeroDR XE, the lightest DR panel available today. Designed to provide unparalleled reliability and high-capacity imaging in extreme "on the go" environments the robust and highly durable AeroDR XE is also ideal for teaching hospitals, portable use and at the bedside.

Built to endure the rigors of extreme imaging environments outside the radiology department, the AeroDR XE combines the industry's most robust wireless DR panel with a simple yet powerful software interface.  As a result, users benefit from the best weight-to-load ratio – up to 661 lbs – and the highest bend and liquid resistance on the market. Weighing only 5.7 lbs, the AeroDR XE is the lightest panel on the market and easiest to handle.

Baxter International net dips by 14% to $468 mn in Q3

Baxter International net profit declined by 14 per cent during the third quarter ended September 2014 to $468 million from $544 million in the corresponding period of last year despite its net sales improved by 13 per cent to $4,197 million from $3,710 million.

These results reflect the income contribution from the vaccines franchise of $21 million and after-tax special items totaling $273 million primarily for intangible amortization and costs associated with upfront and product development milestone payments, integration of the company's acquisition of Gambro AB, and Baxter's planned separation.

Sales within the United States of $1.8 billion rose 7 per cent, while international sales of $2.4 billion increased 18 per cent. Including discontinued vaccines revenues, Baxter's global sales advanced 13 per cent to $4.3 billion and when also adjusting both periods for the contribution of Gambro, Baxter's sales rose 5 per cent, which was at the higher-end of the company's previously-issued guidance. Foreign currency did not have a material impact on sales growth in the quarter.

BioScience revenues of $1.7 billion grew 8 per cent from the prior-year period driven primarily by double-digit growth and continued strong demand for the company's hemophilia therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] and FEIBA (an inhibitor therapy), as well as the benefit from government collaborations and the timing of international tenders. BioScience sales, including vaccines, rose 7 per cent.

MorphoSys buys Lanthio Pharma's lanthipeptide technology

MorphoSys AG, a leading biotechnology companies focusing on fully human antibodies, and Lanthio Pharma, a privately held drug discovery company, announced the acquisition of Lanthio Pharma's lanthipeptide technology, which will be used for drug discovery by MorphoSys.

The acquisition was triggered by MorphoSys exercising an option within an ongoing collaboration and option agreement between the two companies. By exercising the option, MorphoSys takes over the lanthipeptide technology and all related intellectual property. Lanthio Pharma will continue to focus on building its portfolio of selected lanthipeptide drugs and will participate financially in MorphoSys's exploitation of the technology. Financial details were not disclosed.

"Lanthipeptides can become a complementary addition to our therapeutic antibody pipeline and will add more diversity to our drug discovery and development approaches," commented Dr. Marlies Sproll, chief scientific officer of MorphoSys AG. "The decision to acquire this technology was made following a feasibility study to establish high quality and diverse lanthipeptide-based libraries. This brings us closer to adding members of this class of stabilized peptides to our drug portfolio."

As part of its innovation capital initiative, MorphoSys entered a collaboration and option agreement with Lanthio Pharma in November 2012, which included an equity investment as part of the company's Series A financing round.

Chain of events that leads to Alzheimer’s disease

Scientists have for the first time replicated the full course of events underlying the development of Alzheimer's disease inside a lab. A novel 3D culture system replicates the course of Alzheimer's, which doctors feel could significantly reduce time and cost of drug development.

Researchers from the Massachusetts General Hospital in Boston showed that the deposition of beta-amyloid plaques in the brain is the first step in a cascade leading to the devastating neurodegenerative disease. They also identified the essential role in that process of an enzyme, inhibition of which could be a therapeutic target.

The MGH team used a gel-based, 3D culture system to grow human neural stem cells that carried variants in two genes — the amyloid precursor protein and presenilin 1 — known to underlie early-onset Familial Alzheimer's Disease (FAD). Both the genes were co-discovered in lead researcher Rudolph E Tanzi's laboratory.

Novartis receives NPPA notice imposing Rs 300-cr penalty for overcharging

The National Pharmaceutical Pricing Authority (NPPA) has slapped a Rs 300-crore fine on Swiss multinational Novartis for overcharging consumers on sale of Voveran, its best-selling painkiller medicine, according to a Business Standard report.

Voveran is based on diclofenac, a component that is under the government's direct price control, adds the report. According to IMS Health annual data, Voveran, with annual sales of about Rs 225 crore, was among the top 10 brands in the domestic drug retail market as of April this year

B Braun to distribute BSmart injection pressure monitor for PNBs

B. Braun Medical, the market leader in Regional Anaesthesia (RA),announced that it will become the exclusive US distributor of the BSmart injection pressure monitor for peripheral nerve blocks (PNBs) from Concert Medical, LLC. BSmart is the first disposable monitor for measuring of injection pressure during administration of PNBs.

“We want to be the customer’s first choice for delivering RA safely and effectively,” said Joe Cleary, group product director of pain control marketing at B.Braun. “In the coming months, B.Braun will highlight ways to integrate complementary monitoring modalities (injection pressure, ultrasound and stimulation) and share the benefits. We call it ISM, or Injection Safety Monitoring,” added Cleary.

Practitioners already document resistance to injection, however, objective pressure monitoring is a relatively new concept.

Isis Pharma earns $18 mn milestone payment from GSK for advancing phase 2/3 study of ISIS-TTRRx

Isis Pharmaceuticals announced that the company has earned an $18 million milestone payment from GlaxoSmithKline (GSK) related to the advancement of the phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (FAP).

"ISIS-TTRRx is the most advanced drug in our collaboration with GSK, and aside from Kynamro, it is also the furthest advanced in our late-stage clinical pipeline.  We have patients who have completed fifteen months of therapy and are now receiving ISIS-TTRRx in our open-label extension study," said B. Lynne Parshall, chief operating officer at Isis.  "The rapid development of ISIS-TTRRx from a research-stage programme to a drug in a late-stage clinical trial is a testament to the efficiency and productivity of our drug discovery technology platform.  As this programme advances, we will continue to benefit from GSK's resources and expertise as well as earn additional milestone payments."

Bristol-Myers Squibb withdraws asunaprevir NDA from US FDA

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the US, Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration (US FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an

Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.

NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Nitto Denko starts patient dosing in phase 1b study of new anti-fibrosis drug in US

Nitto Denko Corporation announces the initiation of a phase-1b clinical study in the US started on September 2014, to administer a new anti-fibrosis drug in patients for the assessment of safety and efficacy.

Nitto has been developing an RNAi based drug for treating fibrosis in the liver and other organs since 2008 in collaboration with Sapporo Medical University and Hokkaido University. In March 2014, a phase-1 clinical study in healthy volunteers was completed and no remarkable adverse events were observed, even at the highest dose tested. After thorough analysis of the data, the study results were summarised in a Clinical Study Report which concluded that the drug was safe and well tolerated. These results served as the basis of the phase-1b clinical study plan.

The clinical study plan has been approved by a central Institutional Review Board (IRB). This allows Nitto to initiate the phase-1b clinical study in subjects with moderate to severe liver fibrosis for the assessment of safety and efficacy of the drug. Following the start of the US study, Nitto will also conduct a clinical study in Japan

Sagent Pharma recalls - ketorolac tromethamine inj due to incorrect labels

Sagent Pharmaceuticals, a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, announced the voluntary nationwide recall of three lots of ketorolac tromethamine injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent.

Sagent has initiated this voluntary recall of ketorolac tromethamine injection, USP, 30mg/mL to the user level due to labelling the product with the incorrect expiration date. The labelled expiration date is longer than the known stability of the product.

Sagent is not aware of any adverse patient events resulting from the use of this product.

Cell Cure seeks US FDA permission to begin phase I/IIa

HBL Hadasit Bio-Holdings Ltd., and Cell Cure Neurosciences Ltd. (Cell Cure) announced that Cell Cure has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking to initiate a phase I/IIa clinical trial of OpRegen in patients with geographic atrophy (GA), the advanced stage of the dry form of age-related macular degeneration (dry-AMD).

OpRegen consists of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of visual impairment.

The design of the proposed clinical trial, “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy,” is based on a pre-IND meeting with the FDA.. Patients will undergo a single transplantation and the study will explore three different doses of OpRegen. Following transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to moderate the disease progression.

GSK announces $5 mn Fund to advance bioelectronic medicines research

GSK announced a $5 million Innovation Challenge Fund (ICF) to further encourage and advance collaborative research as part of its effort to develop bioelectronic medicines. The fund will support academic groups and small companies who want to develop solutions for GSK’s Bioelectronics Innovation Challenge, which was developed by a group of leading scientists from around the world. This funding programme is in addition to GSK’s prior commitment of a $1 million award, announced in December 2013, for the team that first solves the Challenge.

Bioelectronic medicine is a relatively new scientific field which could one day result in a new class of treatments that would not be pills or injections but miniaturised, implantable devices. The hope is that these devices could be programmed to read and correct the electrical signals that pass along the nerves of the body, to treat disorders as diverse as inflammatory bowel disease, arthritis, asthma, hypertension and diabetes. Since 2013, GSK has committed significant resource to research in this field.

Merck to acquire Sigma-Aldrich for $17 billion

Merck KGaA, a leading company in the pharmaceutical, chemical and life science sectors, has set to acquire Sigma-Aldrich for $17 billion (€13.1 billion) and establishing one of the leading players in the $130 billion global life science industry.

Merck will acquire all of the outstanding shares of Sigma-Aldrich for $140 per share in cash. The agreed price represents a 37 per cent premium to the latest closing price of $102.37 on September 19, 2014, and a 36 per cent premium to the one-month average closing price. The transaction is expected to be immediately accretive to Merck’s EPS pre and EBITDA margin. Merck expects to achieve annual synergies of approximately €260 million (approximately $340 million), which should be fully realized within three years after closing.

Guggenheim Securities and J.P. Morgan are acting as financial advisers to Merck. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal adviser to Merck. Morgan Stanley & Co. LLC is acting as financial adviser to Sigma-Aldrich and Sidley Austin LLP is acting as legal adviser.

Sagent Pharma launches oxaliplatin

Sagent Pharmaceuticals, Inc. has introduced oxaliplatin injection, USP, an antineoplastic agent, now in two liquid presentations. According to IMS, for the 12 months ending July 2014, the US market for oxaliplatin approximated $102 million. As with all products in Sagent's portfolio, oxaliplatin features Sagent's PreventIV MeasuresSM packaging and labeling, designed to help reduce the risk of medication errors.

Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and for treatment of advanced colorectal cancer.

Sagent Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables.  

Telormedix's lead product Vesimune gets European patent

Telormedix, a clinical stage biopharmaceutical company focussed on TLR7 agonists in the treatment of cancer and infectious diseases, has been granted the European Patent No. 2393474 entitled "Pharmaceutical compositions comprising imidazoquinolin (amines) and derivatives thereof suitable for local administration" by the European Patent Office.

The European patent, which will expire in 2030, broadly covers Telormedix’s lead product Vesimune (TMX-101) and its use for the treatment of bladder cancer. Further patents for Telormedix’s Vesimune have also recently been granted in China and Australia.

,Vesimune is Telormedix’s lead product, a TLR-7 agonist currently has successfully completed a phase II trial in CIS (carcinoma in situ) of the bladder. The product is a unique sterile liquid formulation of a marketed immune modulatory compound, designed on innovative technology principles to carrier drug delivery systems in order to increase solubility, bio-adhesiveness and stability. These properties mean that the product can be used in therapeutic settings that the original product could not.

Sigma-Aldrich enters new gene editing partnership with University of Michigan

Sigma-Aldrich Corporation, a leading life science and high technology company, has entered into a new gene editing partnership with the University of Michigan (U-M) Medical School's Vector Core.

Under the partnership, Sigma-Aldrich will provide the Vector Core with Sigma CRISPR technology, experimental design consultation, and dedicated gene editing bioinformaticians.

The partnership is poised to accelerate gene editing-based research at the U-M Medical School. One initiative already underway, led by Assistant Professor Chad Brenner, involves constructing a large library of Sigma CRISPRs for precision studies of the 100 most common genes that have dysfunctions associated with cancer. Brenner's CRISPR library is expected to support the generation of an unprecedented dataset about oncogene functions and drug resistance, leading to improved decision-making for personalized medical treatment of cancer.

Eli Lilly's Trulicity receives US FDA approval to treat adults with type 2 diabetes

Eli Lilly and Company announced that the approval of Trulicity (dulaglutide) by the US Food and Drug Administration is the latest treatment option for adults with type 2 diabetes.

Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies

Biocon purchases GE Capital's stake in Syngene for Rs.215.38 crore

Drug maker Biocon has entered into an agreement with GE Equity International Mauritius, a subsidiary of GE Capital Corporation, to purchase the latter’s stake in Biocon research services subsidiary, Syngene International for Rs.215.38 crore.

GE Capital has 7.69 per cent stake in Syngene of Biocon according to the information shared with the stock exchange.

It was in November 2012, that Biocon signed an agreement with GE Equity International Mauritius, a subsidiary of GE Capital Corporation, to make a primary equity investment of Rs.125 crore in Syngene. GE received a 7.69 per cent equity share in Syngene. The investment from GE Capital saw Syngene’s Post Money Equity Valuation to be Rs.1,625 crore.

Syngene has been a pioneer in the contract research in India and is also recognised as the largest in Asia. It is engaged in integrated drug discovery and development services with a focus on medicinal chemistry, biology, in vivo pharmacology and toxicology. It has a total scientific strength of 1,500 to support the research and development programmes of global pharma, biotech and nutrition companies.

Mylan to buy Arixtra's US rights from Aspen

Mylan Inc's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the US commercialization, marketing and intellectual property rights relating to Arixtra (fondaparinux sodium) injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated.

Arixtra is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip fracture surgery, including extended prophylaxis, hip replacement surgery, knee replacement surgery or abdominal surgery who are at risk for thromboembolic complications. Mylan already is selling Arixtra in the US through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.

Mylan CEO Heather Bresch commented, "DVT/PE is a serious health concern that is estimated to affect up to 600,000 people in the U.S.1 The addition of Arixtra is an attractive opportunity to broaden the range of therapeutic categories we market in the US, in both the hospital and retail settings, and bolster our growing portfolio of complex injectables to better meet our customers' needs."

GSK joins with UK &South African Medical Research Councils

GSK recently announced a £5m collaboration with the UK and South African Medical Research Councils, to support much-needed research into non-communicable diseases (NCDs) in Africa, as part of GSK’s Africa NCD Open Lab initiative.



The funding was pledged today by the UK Foreign Office Minister responsible for Africa, James Duddridge, and South Africa’s Minister for Science and Technology, Naledi Pandor, at an event in Cape Town, South Africa, as part of a broader collaboration between the two countries on scientific research. It will be used to support researchers from South African institutions conducting research projects in NCDs, aligned with the objectives of GSK’s Africa NCD Open Lab.

£2.5m will be provided by the UK MRC, via the UK Newton Fund a government fund established in 2013 to develop science and innovation partnerships that promote the economic development and welfare of developing countries and approximately £1.5m will come from the South African Medical Research Council. GSK will provide an additional £1m, together with a commitment of internal R&D expertise, to support projects within South Africa.  As the first initiative to receive support from the UK / South Africa Newton Fund, this is significant external endorsement for GSK’s open approach to NCD research in Africa.

Navidea inks agreement with Hainan Sinotau Pharma

Navidea Biopharmaceuticals has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organisation with a broad China focus in oncology and other therapeutic areas, who will develop and commercialise Lymphoseek (technetium Tc 99m tilmanocept) injection in China.

In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones from Sinotau, including a $300,000 upfront payment. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved in the US for use in lymphatic mapping to assist in the detection of lymph nodes in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.

As part of the agreement, Sinotau is responsible for costs and conduct of clinical studies and regulatory applications to obtain Lymphoseek approval by the China Food and Drug Administration (CFDA). Upon approval, Sinotau will be responsible for all Lymphoseek sales, marketing, market access and medical affairs activities in  China and excluding Hong Kong, Macau and Taiwan. Navidea and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programmes pending CFDA approval. In addition to the $300,000 upfront, Navidea is eligible for $700,000 in milestones up to and through product approval, and an additional $1.5 million in sales milestones.

BIOCRATES Life Sciences introduces -Metabolomics-based bile acids kit

BIOCRATES Life Sciences AG, developer of cutting-edge mass-spectrometry-based kit products, has launched the first-ever bile acids kit based on targeted metabolite quantitation.

Bile acids are essential for regulating cholesterol metabolism and the intestinal digestion and absorption of fat. Their signaling functions play an important role in chronic disorders, sepsis, or drug metabolism.

BIOCRATES Life Sciences has now developed an assay for the standardized analysis of 16 human specific and 19 mouse specific bile acids from sample sizes as small as 10 µL designed for research use.

The BIOCRATES Bile Acids Kit is based on (ultra) high performance liquid chromatography coupled with electrospray tandem mass spectrometry (UHPLC-MS/MS) and is characterized by quick and highly effective sample extraction on a 96-well patented filter plate. To ensure accuracy and precision, the kit comes with a set of calibration standards, isotope-labeled internal standards, and quality control samples. The assay has been rigorously validated to European Medicines Agency (EMA) guidelines.

Novartis to present data from three clinical trials

Novartis announced that a wealth of new data from its respiratory portfolio will be presented at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany. In total, 44 abstracts (including four late-breakers) will be presented by Novartis, representing more than any other company at the congress.

"Novartis is committed to making a difference to the lives of millions of people worldwide living with debilitating conditions, such as COPD and severe asthma," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals. "We hear from patients how their lives have improved because of our respiratory medicines, and this motivates us to continue to advance respiratory treatments in our portfolio."

Positive new results from the phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro Breezhaler (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone combination: LABA/ICS), in patients with moderate-to-severe COPD.

TaNeDS collaborative drug discovery programme in Europe

Daiichi Sankyo Company, Limited, a global pharmaceutical company, announced details of the application for its Take a New Challenge for Drug Discovery (TaNeDS) Global Programme 2014, a collaborative drug discovery initiative for universities and research institutes in Europe.

The TaNeDS programme was launched in Japan in 2011 to help discover new lines of research through open innovation. From 2013, it expanded abroad, opening up to researchers in Germany, Switzerland and Austria, and becoming known as the TaNeDS Global Programme. Now, in 2014, it has expanded further across Europe to include all EU member countries. The program is conducted with the aim of realizing Daiichi Sankyo’s corporate slogan of “Passion for Innovation. Compassion for Patients.” Through increasing collaborative opportunities with researchers in Europe. U3 Pharma GmbH, a wholly owned subsidiary of Daiichi Sankyo, is also participating in the programme in order to nurture the seeds of drug discovery for the next generation.

The TaNeDS Global Programme 2014:  Countries where research could be conducted: All EU member countries plus Norway and Switzerland.

Overview of research programmes: Daiichi Sankyo seeks innovative technological research collaborators for novel drug discovery and testing projects that could result in novel drug discovery and novel new drugs.

Research themes: 1) Cancer - New targeted and investigative research for small-molecule and biologic treatments (antibody drugs, etc.). 2) Cardiovascular and metabolic disorders - New mechanisms and drug treatments for obesity, kidney and renovascular-related disorders. 3) Other disorders - New mechanisms and drug treatments for genetic disorders, new drug treatments for pain, genetic analysis and new drug research for rare diseases. 4) Revolutionary drug discovery technology - New biologic technology, target molecules and delivery systems for nucleic acid treatments, new technology for drug development based on protein structural analysis.

US FDA grants fast track status to Pfizer’s clostridium

The US Food and Drug Administration (FDA) has granted Fast Track designation to the Pfizer’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhoea and pseudomembranous colitis.




“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio Emini, senior vice president of vaccine research and development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”

Clostridium difficile (klos-TRID-e-um dif-uh-SEEL), often called C. difficile, is the most frequent cause of healthcare-associated infections. C. difficile is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhoea (AAD) and accounts for 15-25 per cent of all episodes of AAD.
FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.

Activity of brain cell networks

Learning is easier when it only requires nerve cells to rearrange existing patterns of activity than when the nerve cells have to generate new patterns, a study of monkeys has found. The scientists explored the brain’s capacity to learn through recordings of electrical activity of brain cell networks. The study was partly funded by the National Institutes of Health.

“We looked into the brain and may have seen why it’s so hard to think outside the box,” said Aaron Batista, Ph.D., an assistant professor at the University of Pittsburgh and a senior author of the study published in Nature, with Byron Yu, Ph.D., assistant professor at Carnegie Mellon University, Pittsburgh.

The human brain contains nearly 86 billion neurons, which communicate through intricate networks of connections. Understanding how they work together during learning can be challenging. Dr. Batista and his colleagues combined two innovative technologies, brain-computer interfaces and machine learning, to study patterns of activity among neurons in monkey brains as the animals learned to use their thoughts to move a computer cursor.

“This is a fundamental advance in understanding the neurobiological patterns that underlie the learning process,” said Theresa Cruz, Ph.D., a programme official at the National Center for Medical Rehabilitations Research at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “The findings may eventually lead to new treatments for stroke as well as other neurological disorders.”

Brain-computer interfaces seek to turn thoughts into action. With small surgically implanted electrodes, researchers can simultaneously monitor the electrical activity of hundreds of neurons. A computer converts the signals into commands to move an external device, such as a robotic arm or a computer cursor. Brain-computer interfaces are being developed to help paralysed patients as well as to study the function of healthy brains.

“This evolving technology is a powerful tool for brain research,” said Daofen Chen, Ph.D., a programme director at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “It helps scientists study the dynamics of brain circuits that may explain the neural basis of learning.”

Pfizer, Merck ink pact to explore potential of combo of Xalkori and pembrolizumab

Pfizer and Merck & Co., known as MSD outside the United States and Canada, through a subsidiary, have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (Xalkori) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).  The financial terms of the agreement were not disclosed.

“This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology.  “Understanding the effects of combining one drug, Xalkori, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients.”

This multi-centre, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study.

“We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck’s investigational immunotherapy pembrolizumab,” said Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories.  “Evidence from early studies of pembrolizumab monotherapy together with Xalkori’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer.

Argentina govt allows imports formulations from India

Argentinian government issued a notification permitting import of generic formulations from Indian pharmaceutical exporters. With this India becomes the 27th country to supply generic formulations to Argentina, a highly regulated market, further establishing India's expertise in this field and proving the capabilities of Indian manufacturers as a supplier of high quality raw materials at the global platform.

For the last 15 years, Argentina imported generic formulations from only 26 countries, listed with them and this move comes as an outcome of the huge effort put by the commerce ministry who had been successful in projecting the qualities of the Indian formulators.

Dr P V Appaji, director general of Pharmexcil, the commerce ministry have been ardently pushing for this matter on behalf of the industry with the Argentinian government, by sending delegates from the ministry and industry to pursue this matter at the earnest with their Argentinian counterparts.

AstraZeneca partners with Illumina to develop next generation

AstraZeneca has entered into a collaboration with gene sequencing company, Illumina, Inc., to develop its next generation sequencing (NGS) platform for companion diagnostic tests applicable across AstraZeneca’s oncology portfolio.

In the first instance, AstraZeneca intends to apply Illumina’s cutting-edge technology to a novel companion diagnostic test in pivotal studies for one of its investigational oncology compounds. This is expected to be one of the first NGS-based companion diagnostic tests for a novel drug in the world, and its application could speed the clinical trial process.

Illumina’s NGS technology allows rapid sequencing of multiple genes in a much faster and cheaper way than traditional DNA sequencing methods. Under the collaboration, it will be used to screen a panel of several gene sequences, scanning for all possible genetic variants — known and unknown — rather than specified mutations from a single tumour sample.

Clinigen buys global rights to oncology support therapy, Ethyol from AstraZeneca

Clinigen Group plc, a specialty global pharmaceutical company, has announced the acquisition of the global rights to the oncology support therapy, Ethyol (amifostine) from AstraZeneca.

Ethyol is a cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New Drug Application (NDA) and in 2013, Ethyol revenue was approximately $4.9million.

This is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir in 2010), and the Group's third oncology support product adding to Cardioxane and Savene bringing the specialty pharmaceuticals portfolio to five products in total.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug ('IND') authorizations are transferred and the technical transfer to a third party manufacturer is completed.   The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing.  The financial terms of the agreement are not disclosed.

AstraZeneca reports positive results from phase III programme of CAZ-AVI

AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections.










CAZ-AVI consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam). CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing threat to public health. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.

The global RECLAIM-1 and RECLAIM-2 phase III studies both evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion (1 g), in hospitalised adult patients with complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In the RECLAIM-1 and RECLAIM-2 phase III studies, CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). CAZ-AVI also treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem.

First-of-its-kind paediatric HIV treatment

Janssen, the pharmaceutical companies of Johnson & Johnson, has launched a first-of-its-kind paediatric HIV treatment donation programme to improve access to the company's approved HIV medicines for children and adolescents failing HIV treatment in sub-Saharan Africa.

At a symposium entitled When Children Need HIV Treatment Beyond First-Line: How Can We All Respond? at the 17th International Conference on AIDS and STIs in Africa (ICASA), Ministries of Health (MOHs) in sub-Saharan Africa were invited to submit a formal Expression of Interest to participate in the charitable paediatric HIV treatment donation programme.

Through this programme, Janssen will donate its HIV medicines PREZISTA (darunavir) and INTELENCE (etravirine), including child-friendly formulations, free of charge to eligible countries with the clinical capacity and willingness to address second- and third-line paediatric HIV treatment. Each child enrolled will receive Janssen's donated HIV medicines as needed until they turn 19 at which point they will be transitioned into the adult national HIV programme or other designated by the national HIV programme for continued treatment.

The donation programme is intended to be a first step in a broader collaborative effort to build awareness, incite action, and advance learning around second- and third-line paediatric HIV treatment in sub-Saharan Africa. Janssen is working with the Elizabeth Glaser Paediatric AIDS Foundation, the Partnership for Supply Chain Management (PFSCM), and MAP International to fully maximize the impact and reach of this initiative.

"The donation programme is part of our longstanding commitment to help people living with HIV and enhance access to our medicines for those in need. Only a third of the three million children living with HIV are receiving medicines today, and of those children receiving treatment, a small but growing number are experiencing HIV treatment failures and are in need of new treatment options," said Paul Stoffels, MD, chief scientific officer, Johnson & Johnson and worldwide chairman, Janssen. "We hope this innovative donation programme is the first step in sparking further collaborative action across sub-Saharan Africa for children who are experiencing HIV treatment failure. Our vision is that these children receive the HIV treatment and care they need to stay healthy and grow to become healthy, productive young adults."

chikungunya vaccine induces robust antibody response

An experimental vaccine to prevent the mosquito-borne viral illness chikungunya elicited neutralising antibodies in all 25 adult volunteers who participated in a recent early-stage clinical trial conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The results are reported in the current issue of The Lancet.

The most distinctive symptom of chikungunya infection is severe joint pain accompanied by headache and fever. There are currently no vaccines or specific drug treatments for chikungunya. First identified in East Africa in the early 1950s, chikungunya virus caused sporadic illness in Africa and large urban outbreaks in Thailand and India in the 1960s and 1970s. It first appeared in the Western Hemisphere in late 2013.

As of August 8, more than 570,000 confirmed or suspected cases had been reported throughout the Americas. In the continental United States, 484 cases have been reported as of August 5, and the first two locally acquired infections were detected in Florida in mid-July.

“The two species of mosquito that spread chikungunya virus are found in parts of the continental United States, so it may just be a matter of time before this illness gains a foothold here,” said NIAID Director Anthony S. Fauci, M.D. “Therefore, it is prudent to begin addressing this emerging public health threat with the development of vaccines, such as this one, which was designed and tested by scientists from the NIAID Vaccine Research Center.”

FDA approves first non-invasive DNA screening test for colorectal cancer

The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

Colorectal cancer primarily affects people age 50 and older, and among cancers that affect both men and women, it is the third most common cancer and the second leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention (CDC). Colorectal cancer screening is effective at reducing illness and death related to colon cancer. The CDC estimates that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided
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Colorectal cancer occurs in the colon (large intestine) or rectum (the passageway that connects the colon to the anus). Most colorectal cancers start as abnormal raised or flat tissue growths on the wall of the large intestine or rectum (polyps). Some very large polyps are called advanced adenomas and are more likely than smaller polyps to progress to cancer.

UM SOM at forefront to develop vaccine for Ebola virus

As the number of lives taken by the Ebola virus in West Africa quickly approaches 1,000, and the US prepares as rapidly as it can, it is clear that little is known in the medical community about the virus. In fact, some experts point out that the number of medical professionals who can properly diagnose and recommend the next steps for treatment is alarmingly small.

Some scientists, however, like Alan Schmaljohn, Ph.D., Professor of Microbiology and Immunology at the University of Maryland School of Medicine (UM SOM), have spent decades studying the Ebola virus and similar viruses identifying key characteristics that have aided in the development of vaccines, antivirals and treatment methods.

As a leader of research and Chief in the Viral pathogenesis and Immunology Branch with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Dr. Schmaljohn was able to help identify three of the key antibodies that are used currently in combination with each other to treat patients infected with Ebola.

Dr. Schmaljohn is now one of the scientific leaders in the UM SOM partnership with Department of Defense contract recipient Paragon Bioservices in the manufacture of an Ebola virus vaccine for initial safety testing in humans.

“Several vaccine candidates for Ebolavirus are proceeding through initial manufacture toward safety testing in human volunteers,” Dr. Schmaljohn said. “Different vaccine candidates are based upon different ‘platforms’ in which selected viral proteins may be made ‘in the test tube’ and purified for injection, or may be added genetically as passengers of a different variety of virus that is weakened. Only human trials will provide the final answers as to which vaccines are best on the basis of many criteria, foremost being safety and efficacy,” he said.

Indian pharma industry

Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.

Endo's subsidiary Paladin launches Travelan in Canada

Endo International plc's subsidiary Paladin Labs Inc. has launched Travelan, a unique over-the-counter product to help reduce the risk of travellers’ diarrhoea.

Travelan is clinically proven to provide protection against the main cause of travellers’ diarrhoea in 90 per cent of consumers who use it. Travelan is a convenient option for all those travelling to at-risk regions such as Central and South America, Mexico, Africa, the Middle East and Asia. It does not require a prescription, and is not associated with any significant side effects.

It is estimated that there are over 5 million trips made by Canadians to at-risk regions every year. One-in-three Canadian vacationers have experienced, or have travelled with someone who has experienced, travellers' diarrhoea. Sources of Enterotoxigenic Escherichia Coli (ETEC) bacteria, which cause the majority of cases of travellers' diarrhoea, can include poorly cooked meat, contaminated raw vegetables or unpasteurized dairy products. Given that no food group can be regarded as "safe"4, research demonstrates that three-quarters of Canadians have indicated that they would take a preventive for travellers’ diarrhoea.

Wrongly labelling drugs under Sch H1 causing confusion to chemists

Concerned over the rising incidence of mislabelling of certain drugs as Schedule H1, pharmacists across the country have urged the regulatory body to urgently look into this matter to clear the confusion among the stakeholders. It was observed by pharmacists that many pharma companies have been wrongly labeling drugs under Schedule H1 category even though they do not fall under the same, creating a lot of skepticism and extra work for the pharmacists.

Schedule H1 which was included in the Drugs & Cosmetics Act after amending the Act in 2013, came into effect from March 1, 2014 consists of a list of only 46 drugs. However, experts point out that there are more products in the market that are being sold under this category than necessary. This they feel needs to be investigated to find out the possibility of any swindling in this matter.

What makes the matter worse for the pharmacists is that under the law, the retailers who are doing manual billing are required to keep separate bill books or separate series of  bill numbers, so that they can produce the records immediately when asked by the drug control officials. With such a long list of medicines it becomes tedious and cumbersome issue for many to keep a record of the drugs, especially when they are well aware that they do not fall under the category.

ReproCELL acquires 3D cell culture

Reinnervate Ltd, one of the leading companies in the field of 3D cell culture, has been acquired by ReproCELL of Shin-Yokohama in Japan. ReproCELL, a pioneer in the field of induced pluripotent stem cell biology supplies iPSC-dervided Hepatocytes, Neurons and Cardiomyocytes as well as a range of media and reagents for stem cell culture.

ReproCELL intends to combine it’s iPSC-derived cells with the Alvetex range of 3D cell culture products to produce and sell next-generation tools for drug toxicity testing, neuroscience and cancer research.




ReproCELL also announced the acquisition of BioServe Inc of Maryland, USA, a leading supplier of human tissues and other biological samples with one of the largest commercial biorepositories in the world.

ReproCELL plans to use the unparalleled access to human tissues to generate a wide range of disease-related iPSC lines for production of human disease cell models.

Aeterna Zentaris, ASCEND ink co-promotion pact for US market

Aeterna Zentaris Inc.,  a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, announced a strategic co-promotion services agreement with ASCEND Therapeutics US, LLC, (ASCEND), a specialty pharmaceutical company solely focused on women's healthcare.

Under the terms of the agreement, expected to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific US territories, ASCEND's EstroGel a non-patch transdermal US Food & Drug Administration (FDA) approved and commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific US territories, Macrilen, Aeterna Zentaris' product for use in the evaluation of adult growth-hormone deficiency (AGHD), for which a New Drug Application (NDA) is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of November 5, 2014. In consideration for these co-promotion services, each party will be entitled to receive, from the other party, commissions on net sales of each other's product.

Medical devices industry needs separate set of rules

AdvaMed, an association of medical device manufacturers, stressed that in the light of many regulatory hurdles the industry is facing in India, it is high time for the government to frame a specific set of acts and rules for the medical devices industry. The association welcomed the government’s effort to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non- communicable diseases.

AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”

ANI Pharma buys US rights for Vancocin capsules from Shire

ANI Pharmaceuticals, an integrated specialty pharmaceutical company, has acquired the US rights for Vancocin 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company.

In addition, ANI acquired from Shire approved ANDAs for the currently non-marketed products vancomycin hydrochloride injectable 500 mg, 1 gm and 10 gm ($45 million in 2013 market value, per IMS Health) and vancomycin hydrochloride oral solution 250 mg and 500 mg. ANI paid $11 million in cash for the rights to Vancocin together with existing inventories on hand. Following a transition period, ANI intends to launch Vancocin capsules under its own label during the fourth quarter of 2014. The transaction is immediately accretive and sales of Vancocin capsules are expected to generate approximately $5.4 million in revenues and $4 million in non-GAAP EBITDA annually.

Arthur S. Przybyl, ANI’s president and chief executive officer, stated, “We are excited to add Vancocin capsules to our portfolio of mature brand products. In addition, we will immediately begin exploring opportunities to launch both vancomycin injectable and vancomycin oral solution. Year to date we have invested $23 million in two mature brand acquisitions that will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBITDA. At the same time, we are continuing to advance our internal generic product development pipeline while selectively pursuing acquisitions and partnerships that augment those efforts.

Maha FDA files FIR against stockists for refusing to supply medicines

To ensure compliance to the conditions of wholesale licence and Drug Price Control Order (DPCO-2013), Maharashtra Food and Drug Administration (FDA) has filed an FIR against a stockist at Bhiwandi Police Station for refusing to supply medicines in contravention to DPCO and Essential Supplies Maintenance Act (ESMA). This is the first such case detected by the state regulator since it intensified its drive last month against errant wholesalers.



The state as of today has 18000 wholesalers including those who export and import. Out of which, there are around 4000 stockists who supply to the retail trade. FDA has intensified the crackdown on the errant wholesalers from last month considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant.

Takeda Pharma net dips by 6.2%

Takeda Pharmaceutical Company of Japan has posted lower net profit of Yen 34 billion during the first quarter ended June 2014 as against Yen 36 billion in the corresponding period of last year due to stagnant sales, higher input costs and launch of new products in the US. Its revenue improved marginally by 0.2 per cent to Yen 411 billion from Yen 410 billion. Its earnings per share worked out to Yen 42.40 as compared to Yen 45.53 in the last period.

The company's sales of Ethical drugs improved only by 0.5 per cent to Yen 372 billion as its sales in Japan declined by 2.2 per cent to Yen 138 billion. Contribution from sales increase of products launched in and after 2010 such as Asilva and Nesina could not fully absorb the decrease in sales mainly due to the National Health Insurance price reduction and the penetration of generic products. However, its overseas sales improved by 2.7 per cent to Yen 234 billion due to higher sales of Velcade in the US and Pantoprazole in emerging markets including Asia.  

US FDA announces FY 2015 animal drug user fee rates for ADUFA & AGDUFA

The US Food and Drug Administration (FDA) announced in the Federal Register the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).

ADUFA, originally signed into law in 2003 and reauthorized in 2008 and 2013, amends the Federal Food, Drug, and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources support FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals that produce food for consumption. ADUFA III reauthorizes FDA to collect user fees through FY 2018.

Dow Corning opens application development centre in Mumbai

Dow Corning, one of the leading global players in innovative silicon-based technologies, has set up a new application development centre in Mumbai to serve the growing demand for silicone materials and services in the India region. This centre enables state-of-the art local support for Dow Corning’s global innovation and sustainability initiatives, as well as closer collaboration with customers to provide solutions customised for the region.

India terms US 'Special 301' process

India has termed the recently released United States Trade Representative (USTR) 2014 “Special 301 Report” a unilateral measure taken by the US to increase Intellectual Property Rights (IPR) protection beyond the TRIPS Agreement.

“The Special 301 process is a unilateral measure taken by the United States under their Trade Act, 1974 to create pressure on countries to increase IPR protection beyond the TRIPS Agreement. It is an extra territorial application of the domestic law of a country and is not tenable under the overall WTO regime”, Union Minister for Commerce & Industry Nirmala Sitharaman said.

India has a well-established legislative, administrative and judicial framework to safeguard Intellectual Property Rights which meets its obligations under the Agreement on Trade Related Intellectual Property Rights (TRIPS) while utilizing the flexibilities provided in the international regime to address its developmental concerns, the minister in a written reply said in Rajya Sabha on July 30.

AstraZeneca to acquire rights to Almirall's respiratory

AstraZeneca has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira (aclidinium); LAS40464, the combination of aclidinium with formoterol which has been filed for registration in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and phase I (LAS190792); and multiple pre-clinical programmes. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca.

Pfizer net earnings dips by 79% in Q2 to $2,912 million

Pfizer Inc, a second largest pharmaceutical company in the world after Novartis, has suffered heavy setback during the second quarter ended June 2014 on account of one time income received from sell of animal health business, Zoetis Inc.,  for a consideration of $10.4 billion in the last period. The net profit declined by 79.3 per cent to $2,912 million from $14,095 million in the corresponding quarter of last year. Its revenues also declined by 1.5 per cent to $12,773 million from $12,973 million due to multi-source generic competition for Celebrex in the US and destocking by wholesaler and retailer.

The company began managing its commercial operations through a new global commercial structure consisting of three operating segments viz., Global Innovative Pharmaceuticals Segment (GIP), Global Vaccines, Oncology and Consumer Healthcare segment (VOC) and Global Established Pharmaceutical segment (GEP).

KaloBios regains rights to KB001-A

KaloBios Pharmaceuticals, has recently provided an update on the status of the KB001-A development programme, including an update on its KB001-A collaboration with Sanofi Pasteur.

KaloBios has reached an agreement with Sanofi Pasteur to regain all rights to KaloBios' KB001-A programme. Under this agreement, the collaboration and licencing agreement entered into in 2010 has been terminated. Under that collaboration agreement, Sanofi Pasteur had been developing KB001-A, a patented monoclonal antibody targeting Pseudomonas aeruginosa (Pa), for Pa pneumonia prevention in the intensive care setting while KaloBios had been developing KB001-A for chronic treatment of Pa lung infections in cystic fibrosis (CF) patients.

Novartis net up by 3% to $3,283 million in Q2

Novartis International AG has posted marginal growth in profits as well as sales during the second quarter ended June 2014 due to lower sales of Diovan in Japan and US. Its net profit moved up by 3 per cent to $3,283 million from $ 3,188 million in the similar period of last year. Its net sales improved marginally by 2 per cent to $14,637 million from $14,637 million. EPS worked out to $1.24 as against $1.29 in the last period.

The major products like Gilenya, Afinitor, Tasigna, Galvus, Lucentis, Xolair, the COPD portfolio and Jakavi contributed 42 per cent of of pharmaceutical division sales as compared to 36 per cent in the last period. Sales growth was impacted by Japan, which saw a continued decline in Diovan sales and biennial price cut for many brands. US sales of Diovan impacted due to inventory destocking ahead of the generic entry in July 2014.

Alcon net sales improved 3 per cent in second quarter ended June 2014 due to growth in ophthalmic pharmaceuticals and surgical, coupled with strong emerging growth markets performance. The sales of Sandoz division increased by 19 per cent to $ 2.3 billion, as volume growth of 11 percentage points more than compensated for u percentage points of price erosion. However, Asia (excluding Japan) delivered double-digit sales growth.

Strides invests in Oncobiologics

Strides Arcolab has now made a strategic investment in Oncobiologics Inc, which is a privately held New Jersey-based biopharmaceutical firm developing a pipeline of biosimilars and next generation bio-therapeutics. The financial details have not been  disclosed.

According to the Bengaluru-based Strides, the investment is part of its efforts to fund promising bio-pharma companies with high quality scientific management and proprietary approaches to developments that confer significant time and cost advantages.

“The investments by Strides Arcolab represent important milestones for Oncobiologics.  The company is a long-term strategic partner that provides both financial strength and a proven track-record of successful business ventures.  We look forward to their support and guidance as we continue to execute Oncobiologics’ business and technical plans,” said Dr Pankaj Mohan, Founder & CEO, Oncobiologics.