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Contents
Generic Zyrtec
Syrup
Women in Science New Adjuvants Solar Power in India Indian Drugmakers’ R&D Spending Soars Rapid Response Innovation Awards No More Innovators Generic Zyrtec Syrup Cetirizine Hydrochloride syrup is indicated for relief of symptoms associated with seasonal allergic rhinitis in adults and children above two years of age. It is the generic equivalent of McNeil Consumer Healthcare's Zyrtec syrup. Aurobindo Pharma said it has received the final approval from the US drug regulator for its anti-allergic syrup. Aurobindo has a total of 110 ANDA (abbreviated new drug application) approvals, including 82 final and 28 tentative from the US FDA, it added. Women in Science: Analyzing The Glass Ceiling Women make up approximately half of the world’s population, but have traditionally supplied a smaller proportion of the workforce. This has been changing over the years, and by October 2009, there was a breakthrough in women’s employment — according to a report by the Center for American Progress and Maria Shriver, women made up half of the U.S. workforce for the first time in history. In the pharmaceutical and medical industry, according to the U.S. Equal Employment Opportunity Commission’s 2005 Report, around half of the employees (48.8%) are women. This fact is reflected by Fortune’s 2007 “Top 100 companies to work for,” which included six pharmaceutical companies and breaks out employment by gender as: Genentech – 50% women Amgen – 46% Genzyme – 55% Alcon – 47% AstraZeneca – 54% Medtronic – 46%. While many companies have achieved parity between the sexes at entry level, and even up to middle management, there are still more men than women at board level and in C-level posts. In Europe, according to figures from the Third Bi-annual EuropeanPWN (European Professional Women’s Network) BoardWomen Monitor 2008, looking at the boards of the top 300 European companies, three out of four of these include one or more women. However, only 9.7% of the board members were female, up from 8.5% in 2006 and 8% in 2004. Excluding Norway (where government legislation mandates that at least 40% of board members must be female), the average female board membership is 9.1%. Life Science Leader, January 2010, http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3939 Women were less likely than men to receive major funding for scientific research, according to a study from the University of Michigan Health System. The study also found that only a quarter of all researchers, both men and women, who received a major early career award went on to get further federal funding within five years. The study looked at 2,783 researchers who received the highly competitive early career awards called K08 or K23. These awards provide funding that protects a researcher’s time and include a mentoring component to help nurture a young clinician-scientist’s career. The funding is typically for three to five years. The researchers then matched the K award recipients to those who were awarded an R01, a prestigious federal grant that is a milestone in a researcher’s career. They found that within five years of a K08 or K23 award, only 23 percent of all researchers had attained an R01. But while 25 percent of men had been awarded an R01, only 19 percent of women had. After 10 years, fewer than half of all K awardees had an R01: 36 percent of women and 46 percent of men. Results appear in the Dec. 1 issue of Annals of Internal Medicine. The authors suggest that family demands, including childbirth, could pull some women scientists from their careers. Women may also be more likely to feel pressures to contribute to the clinical workload and be less successful at negotiating with their department chairs for adequate time to devote to research. Medivation, Inc. has recruited a new senior vice president, clinical development, Karen Reeves, M.D., and Vandana Date will be the new vice president, intellectual property. Dr. Reeves received her B.A. from Yale University and M.D. from the University of Vermont Medical School. Ms. Date joined Medivation in April 2007 as senior director of intellectual property, bringing 14 years of intellectual property related experience and over five years of experience as a research chemist. Prior to joining Medivation, she served as a director of intellectual property at Threshold Pharmaceuticals, Inc. and a patent attorney at ALZA/Johnson & Johnson and held various patent-related positions at Robins & Associates and Glycomed Inc. Ms. Date received her M.S. in chemistry from both Bombay University and Duke University and a J.D. from Golden Gate University School of Law. (With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer's medications in patients with mild, moderate and severe Alzheimer's disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy.) ImmunoGen, Inc., a biotechnology company that develops targeted anticancer products, announced the appointment of Suzanne Cadden as Vice President of Regulatory Affairs & Quality. New Adjuvants Adjuvants are immune-stimulating substances that are added to boost the effect of the vaccine. One problem in developing cheap vaccines has been the lack of adjuvants. However, there has now been a major breakthrough in this area, according to a study, led by scientists at Uppsala University, published in the December issue of the journal Vaccine. Many of the treatment methods that are developed today for allergies, cancer, and autoimmune diseases are based on the use of monoclonal antibodies. The cost of these protein pharmaceuticals is high, between 15000 and 150000 dollars per patient per year. Therapeutic vaccines contain no pre-produced antibodies but rather stimulate our immune system to produce its own therapeutic antibodies. They are considerably less expensive to manufacture than the drugs that are now being produced. Therapeutic vaccines that target the same molecules in the body as the various monoclonal antibodies would enable us to reduce the cost of treatment significantly, and also decrease the number of visits patients need to make to the clinic. Solar Power in India The government of India has agreed to a project aimed at generating 20 gigawatts of solar electricity by 2020. The project is expected to cost $19 billion which will cover research and development as well as subsidies for the manufacturing firms. This is India’s first national solar power program. Indian Drugmakers’ R&D Spending Soars R&D spending by India’s 25 leading drugmakers grew nearly 17% overall in 2008-9, with a number of firms increasing their investments by over 40%, according to a local survey. Total R&D spending by the 25 firms reached 32.1 billion rupees, representing 7.75% of their sales, up slightly on the 7.60% level reported for the previous year, according to a survey conducted by the Pharmabiz news service. Among the companies which increased their R&D spend by more than 40% during the year were Ind-Swift, Jubilant Organosys, Matrix, Piramal Healthcare, Sun Pharma Advance Research Co and Stride Arcolab, says the survey, which also reports increases of 15%-40% for firms including Biocon, Cadila Healthcare, Ipca, Fresenius Kabi Oncology (formerly Dabur) and Lupin. The year’s biggest investor in R&D was Ranbaxy, spending a total of 4.71 billion rupees, just 2.4% more than the previous year. The next biggest spender was Dr Reddy’s Laboratories, then Lupin. Other international names whose R&D investments grew by single-digit amounts last year include Cipla, Sun Pharma, Torrent and Alembic. A number of big firms cut back their R&D investments for the year, including Ajanta Pharma, Aurobindo, Dr Reddy’s, Glenmark, Orchid, Panacea Biotech, Shasun Chemicals, Unichem and Wockhardt, says Pharmabiz. Another report puts the total value of India’s pharmaceutical industry in 2008-9 at $10.8 billion and forecasts that this will double to $20.9 billion in 2014. The sector’s exports soared 30.3% in the year to 394.5 billion rupees, says the report, from Research and Markets. It goes on to forecast that high levels of investment in R&D, the filing of greater numbers of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) in highly-regulated markets, plus mergers and acquisitions, in-licensing, a skilled labour force, high-standard scientific base and revenues from contract research and manufacturing services (CRAMS) will give Indian drugmakers the “necessary edge” in the years to come. According to the Pharmabiz survey, Dr Reddy’s filed 23 ANDAs during 2008-9, received approval for the same number of ANDAs and launched 16 new products onto the US market. Also during the year, Orchid filed 58 ANDAs, Lupin filed 28, and the totals for other firms included: Glenmark – 22, Matrix – 20, Aurobindo Pharma – 19, Cadila Healthcare – 19, Alembic – 8 and Ranbaxy – 6, it says. http://www.pharmatimes.com/WorldNews/article.aspx?id=17123 Rapid Response Innovation Awards from the Michael J Fox Foundation The Michael J. Fox Foundation for Parkinson's Research closes 2009 with $2.1 million in awards to high-risk, high-reward approaches to Parkinson's therapeutic development through its Rapid Response Innovation Awards. Over the course of the year, the funds were awarded to 28 research teams working on a broad range of projects, including the development of neuroprotective approaches to treat PD; therapies to alleviate symptoms; therapeutic targets for genes associated with PD; preclinical models of PD; and disease and drug biomarkers. The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinson's disease through an aggressively funded research agenda. MJFF has funded more than $162 million in research to date. No More Innovators Pfizer Inc, the world's largest innovator drugmaker, will start selling generic drugs in Japan sometime after 2010. Pfizer Japan had said on Nov. 19 that the U.S. company might start selling generic drugs in Japan from 2011 as part of efforts to diversify its operations. Takeda Pharmaceutical, Japan's largest innovator drugmaker, said that it may enter generic markets abroad. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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