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.