new point-of-care system for HIV/AIDS CD4 monitoring in India

Becton, Dickinson and Company has now unveiled the  BD FACSPresto, a near patient CD4 monitoring system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples.

The device weighs  less than 7kgs and  is capable of testing samples from a single drop of capillary or venous blood and can work for 6 hours using in-built rechargeable battery, enabling testing even in remote settings.

National AIDA Research Institute (NARI), Pune conducted a product evaluation study on the new near patient CD4 Counter system on close to 150 samples and have claimed the accuracy of the tests after conducting a systematic study.  The Institute researchers found that the accuracy and precision levels of BD FACSPresto was equivalent to the current gold standard.

CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV, according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.

Sigma introduces Next-Gen Sequencing Oligos

Sigma Life Science, an innovative biological products and services business of Sigma-Aldrich Corporation, released Next-Gen Sequencing Oligos, custom next-generation sequencing adapters that improve target sequence assembly. These oligos are expected to allow researchers to achieve better results from multiplexing experiments. "Sigma-Aldrich is the first oligonucleotide manufacturer to provide a cross-contamination threshold," said Carlos Martinez, development manager at Sigma-Aldrich. "This gives our customers the confidence they need from the start, minimizing the time and expense created by the need to experiment with less consistent products to achieve proper sequence assembly." Next-generation sequencing adapters are required for the proper assembly of genome sample fragments. Adapters, especially barcode sequences, containing unacceptably low full-length sequence or excessive cross-contamination with other barcode sequences can lead to compromised sequence read integrity and improper sequence assembly. These types of problems are often undetectable until the data analysis stage, which make them costly in terms of time and money. Sigma's Next-Gen Sequencing Oligos are manufactured under rigorous conditions to ensure suitable purity and low levels of cross-contamination. "With cross-contamination thresholds as low as 0.25% or less, and both ISO 9001 and 13485 manufacturing available, Next-Gen Sequencing Oligos are ideal for research, life science research tool and molecular diagnostic applications," said Martinez. Sigma Life Science is a Sigma-Aldrich business that represents the company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Sigma-Aldrich, a leading life science and technology company focused on enhancing human health and safety, manufactures and distributes 230,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets.

Sanofi inks research pact with Lead Pharma to develop treatments for autoimmune diseases

Sanofi has entered into a research collaboration and license agreement with Lead Pharma,  a Dutch biotech company, to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma (t) to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common.

"Anti-ROR gamma (t) therapies represent a ground-breaking opportunity that we are eager and motivated to pursue through our collaboration with Lead Pharma," said Christian Antoni vice president and head of the immunology & inflammation franchise, research & development, Sanofi. "At Sanofi, we believe networked innovations - working collaboratively across science sectors - is the most effective way to bring meaningful new therapies to patients. To this end, Lead Pharma's innovative capabilities and productivity, exemplified by the ROR gamma (t) programme, make them ideal partners for Sanofi in this area of drug discovery."

Boston Scientific to pay $600 mn to J&J to resolve Guidant litigation

Boston Scientific Corporation announced the settlement of the breach of merger agreement lawsuit brought by Johnson & Johnson against Guidant Corporation, stemming from Boston Scientific's acquisition of Guidant. In the lawsuit filed in 2006, Johnson & Johnson alleged that Guidant breached the merger agreement it had with Johnson & Johnson, and sought more than $7 billion in damages. Guidant disputed the allegations. As a result of the settlement agreement, Johnson & Johnson has agreed to permanently dismiss its action without acknowledgment of liability by Guidant.

Additionally, Boston Scientific will make aggregate payments totaling $600 million to Johnson & Johnson.  Boston Scientific expects to record a pre-tax litigation-related charge of approximately $600 million within its fourth quarter 2014 results as a recognised subsequent event. This charge will be excluded from Boston Scientific's non-GAAP measures of adjusted income that were previously announced. In connection with the settlement, Boston Scientific has also agreed not to bring patent infringement or other claims related to Johnson & Johnson's S.M.A.R.T., S.M.A.R.T. Control, and S.M.A.R.T. Flex stent products.

"We feel this settlement is in the best interests of the company and its shareholders," said Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary. "We are pleased to end this longstanding litigation between Guidant and Johnson & Johnson, and to continue focussing on delivering innovative products and solutions to physicians and patients."

 

Teva Pharma launches generic Lovenox & Zyvox in US markets

Teva Pharmaceutical Industries, a leading global pharmaceutical company, announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin s injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT.

Lovenox had annual sales of approximately $1.8 billion in the United States, according to IMS data as of November 2014. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of enoxaparin sodium injection, USP.

Teva has also recently launched the generic equivalent to Zyvox (linezolid) injection which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox injection had annual sales of approximately $464 million in the United States, according to IMS data as of October 2014.

“Teva is committed and focused on building a stronger generic injectable business globally,” said Siggi Olafsson, president and chief executive officer, of Teva Global Generic Medicines. “With the launch of enoxaparin sodium injection, USP and Linezolid injection, accompanied by the reintroduction of three generic injectable products, we are leveraging the strength of our internal and external resources to deliver the right portfolio as part of our growth strategy. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic.”

Teva continues to invigorate the injectable business in the United States with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Additionally, Teva has progressed in building its research and development capabilities in complex, generic injectables including drug-device combinations, complex drug delivery, and complex molecules. This month, Teva has launched Nafcillin for injection, USP and is reintroducing into the market Leucovorin calcium for injection (100 mg/vial), methylprednisolone acetate injectable suspension, USP (40 mg/mL), and ondansetron injection, USP (2 mg/mL).

As of January 22, 2015, Teva had 120 product registrations pending FDA approval, including 29 tentative approvals. Collectively, these 120 products had US sales in 2014 exceeding $86 billion. Of these applications, 87 were “Paragraph IV” applications challenging patents of branded products; 42 of these pending ANDAs are potential first-to-file opportunities.

Excel Gas & Equipments bags contracts from pharma majors

Mumbai-based Excel Gas & Equipments, one of the India’s leading project management companies that operates in the field of gas piping installation for all research laboratories of pharma giants has recently received huge contracts from IOCL, Novartis, GVK Bioscience, Syngenta and Indian Institute of Science Education & Research.

Excel Gas has now turned out to become one of the leaders and major players in turnkey installation of gas handling systems. They have also expanded their wings in the Middle East market. In the pharmaceutical industry, the company has executed projects from concept to commissioning for major players like Cipla, Dr. Reddy’s, Biocon, Novartis, Mylan, Pfizer, GVK, Syngenta, and Hikal.

After successful completion of over 400 plus projects spread all over India and in the Middle East, today Excel Gas and Equipments  stands tall in this industry and is the single point solution for design, procurement, installation and ensuring continued performance of gas handling systems.

Nitin Godse, MD, Excel Gas & Equipments, said: “The contract includes understanding client requirement, design, procurement, installation and of gas handling systems. Generally end users of gases like scientists, pharmaceutical technicians, semiconductor fab technicians are expert in their own domain. Gases being utility for their domain, they look at people who are expert in handling gases.”

He adds further, “Major safety hazards are associated with handling of gases. We need to understand that handling of gases is different than handling liquids. Gases are compressible, hence large quantity of gas is stored under high pressure into confined containers like cylinders, bullets etc. Depending on the nature of gas they are filled at various pressures ranging from 2 bar to 220 bar and sometimes even higher. Uncontrolled release of this compressed gas will cause serious safety hazards and can lead to fatal accidents. Design precautions, Correct material and fabrication methods for gas handling systems, hazard analysis, operator trainings can avoid accidents in plant laboratories.”

Godse also said that when compared to European countries, very limited regulations related to gas handling systems are available in India. Frequently referred standards and codes include NFPA 55 for fire and related hazards, PESO for use of compressed gases and OSHA for safety of the users. Apart from these, ASME B31.8 is generally referred for designing and tubing. Recently FDA has become very stringent with regulations for pharma sector particular in India.

Mundipharma partners with Direct Relief to donate Betadine to support the fight against Ebola in West Africa

Mundipharma, a network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets, has partnered with Direct Relief to donate supplies of its Betadine range of anti-virals to support the aid organisation’s efforts to contain the current outbreak of Ebola in West Africa. With the partnership, Mundipharma will provide more than two million anti-viral hand washes to the Ebola treatment centres of West Africa.

The Ebola outbreak has killed more than 1,000 people, prompting the World Health Organization (WHO) to declare it a worldwide public health concern. This outbreak has spread rapidly through human-to-human transmission causing wide spread concern globally.

According to the European Centre for Disease Prevention and Control, the Ebola virus is frequently found in saliva with evidence stating that close face-to-face contact without adequate personal protective equipment (including eye protection) puts others at moderate risk of acquiring the disease. Those at higher risk of infection include health workers, family members in close contact with infected people and mourners who have direct contact with the bodies of the deceased as part of burial ceremonies.

One of the possible reasons the virus has spread so rapidly in West Africa is due to the insufficient level of healthcare. The best way to reduce the possibility of contracting the disease is to practice proper hygiene.  According to World Health Organisation guidelines, hand hygiene is the most important infection prevention and control measure.

Raman Singh, president, Asia Pacific, Latin America, Middle East, and Africa, commented: “Mundipharma is committed to support the international aid efforts against Ebola.  We hope that our proactive approach will enable Direct Relief to continue to quickly and efficiently provide important preventative measures in limiting the outbreak of this serious and growing health issue.

“The donation of Betadine is wholly consistent with our mission and commitment to improving the health and quality of life of the human race everywhere, even in the most extreme circumstances such as these and emphasises our focus on caring for those most in need.  Betadine® has been used and trusted as an antiseptic for more than 50 years, multiple publications of Betadine and its general virucidal activity exist which is why we believe the Betadine® range can play an important role in the fight against the spread of Ebola.”