Today's Top Stories Also Noted: Spotlight On... Otsuka inks licensing deal; Neurocrine touts trial data; Biolex, OctoPlus to collaborate; Bioenvision enrolling patients; and much more...
Chutes & Ladders: Sponsored by Adsumo 1. New FDA board to monitor safety of approved drugs Amid bold pronouncements of the federal government's renewed commitment to protect the public from dangerous drugs, HHS Secretary Mike Leavitt has created a new Drug Safety Oversight Board at the FDA that will be responsible for monitoring the safety of approved drugs. Administration officials, including FDA acting commissioner Lester Crawford, said that the new board would provide independent oversight to protect the public from drugs that have dangerous side effects unknown at the time they are approved. There remain a host of skeptics, though, who point to the fact that most of the board will be appointed from the ranks of the FDA and other federal agencies. And the FDA's own chief critic, Dr. David Graham, says that the new board fails to resolve the root cause of the issue: making drug safety as important as quick approval. The move comes on the eve of an expert panel meeting that will review Cox-2 inhibitors and consider new safety warnings or a possible ban. And the New England Journal of Medicine released new study information linking the entire drug class to higher risks of heart attacks and strokes. - read this story from the Washington Post for more details
2. FDA experts recommend strong warning for eczema treatments An FDA expert panel has recommended that two eczema treatments, Elidel and Protopic, should carry urgent warnings that they can cause cancer, particularly in children. The drugs' popularity has soared, with more than 12 million prescriptions written for both. Novartis, which makes Elidel, said that it thought that the recommendation was unnecessary. - read this article from the Washington Post for more details 3. Ivax buying Phoenix Scientific for $272M The generic drug maker Ivax has reached a deal to buy Phoenix Scientific, which makes generic veterinarian drugs, for $272 million. Ivax officials say they will fold the St. Joseph, Missouri, company into its SVM Pharmaceuticals division. Ivax will pay $196.9 million in cash and the rest in stock. "Phoenix, like DVM, is a company with a superior reputation and management; it will be an important addition to Ivax's existing veterinary operations and greatly enhance our ability to compete in the U.S. animal health market," said Jane Hsiao, Ivax's CEO of DVM, in a statement. - read this story from the AP for more details 4. Analysts pick most likely mega-mergers of 2005 Analysts say that a number of giant drug companies with deep pockets but weak drug pipelines are prime candidates to launch new mergers this year. Pfizer, Merck and GlaxoSmithKline all meet the profile of a likely suitor, with Bristol-Myers Squibb, AstraZeneca and Wyeth looking like appetizing targets. Some analysts are particularly enchanted by the possibility of Merck and Schering-Plough pairing up. Both jointly market cholesterol drugs already. - read this article from The Wall Street Journal for more details (sub. req.) 5. Solvay gets priority FDA review for supplemental NDA on Aceon The FDA has agreed to give a priority review to Solvay Pharmaceuticals' supplemental NDA for Aceon. Solvay wants to expand the indications for Aceon to include reducing heart disease for patients with stable coronary artery disease who do not suffer from heart failure. Aceon is currently used to control blood pressure. Solvay says it expects a decision by June 10. - read this press release for more details ALSO NOTED
TODAY'S SPOTLIGHT... Otsuka inks licensing deal > Neurocrine is reporting positive Phase III data for Indiplon modified release tablets in treating adults with chronic insomnia. Release > Biolex and OctoPlus have agreed to collaborate on the co-development of a controlled release formulation of recombinant human alfa interferon. Release > New York-based Bioenvision has begun enrolling patients for a Phase II trial to evaluate the efficacy of Virostat for chronic hepatitis C. Release > PediaMed of Florence, Kentucky, has inked a co-promotion deal with Allergan for Zymar, a treatment for eye infections. Release > San Diego-based Gen-Probe has signed a supply and purchase deal with Roche to purchase products for use in molecular diagnostic assays for human papillomavirus. Release And Finally... A study involving 90,000 Japanese adults concludes that coffee drinkers are far less likely to suffer liver cancer. Article
Astralis has named James Sharpe as CEO. Prior to joining Astralis, from 1999 to 2005 Sharpe served as president and founder of Ankyr Consulting, an independent consulting company. Sara Cunningham has been confirmed as Benitec's new CEO, expanding the company's board to a total of seven members. Cunningham joined Benitec in May 2004 as COO through its acquisition of Avocel. She was a co-founder and vice president, intellectual property and business development of Avocel. Dr. Hans T. Schambye has been appointed as Gastrotech's CEO. He replaces Professor Claes Post, who will continue to serve the company as a member of Gastrotech’s board of directors and senior vice president. Dr. Schambye has served as Gastrotech’s senior vice president of research and development since March 2004. Tod R. Hamachek has resigned as chairman and CEO of Penwest Pharmaceuticals for personal reasons. Penwest also announced that Robert J. Hennessey, a member of the company's board, has assumed Mr. Hamachek's responsibilities as CEO. GeneMax has promoted Konstantine Sarafis to president and CEO and appointed Dr. Glynn Wilson as a director. Sarafis had been COO. R. Douglas Hulse has been elected president and COO of Hemispherx Biopharma. Hulse is an executive director of The Sage Group. Inspire Pharmaceuticals' chairman of the board, Leigh Thompson, has died. Kenneth B. Lee, Jr., vice chairman of the board, is serving as interim chairman until the board appoints a permanent chairman. ImClone Systems has named Philip Frost, MD, PhD, as executive vice president, chief scientific officer, and Eric K. Rowinsky, MD, as senior vice president, chief medical officer. Dr. Jean-Yves Bonnefoy has been named TransGene's new chief scientific officer. He replaces Serge Braun, who has decided to pursue other opportunities outside of the company. Prior to joining Transgene, Jean-Yves Bonnefoy, 45, was head of the Canceropole Lyon Rhones-Alpes. Antares Pharma has hired James E. Hattersley as its vice president of corporate business development. Hattersley had been senior director of business development at Eurand, a global drug delivery and specialty pharma company. Gary Gabriel, PhD, has been named as LifeTree Technology's vice president of sales and business development. Dr. Gabriel has 19 years experience in biotechnology. Kyle McAllister will join Radiant Research as vice president of business development. Prior to joining Radiant Research, McAllister served in a number of roles at MDS Pharma Services, most recently as vice president of business development. Martin D. Williams has been appointed vice president and head of corporate development at Altus Pharmaceuticals. Williams had been senior vice president of corporate development and marketing at Oscient Pharmaceuticals. Schering-Plough has appointed Winston K. C. Lam as vice president and associate general counsel, business development and strategic alliances. Lam joins Schering-Plough from McKesson, where he was senior vice president, business development for its Medical-Surgical unit. Stephen J. Plating has joined Alphavax as senior director of quality assurance. He joined AlphaVax from GlaxoSmithKline, where he was vice president, quality - North America. Millipore has appointed Martin D. Madaus, PhD, as chairman of the board. Dr. Madaus became Millipore's CEO and president on January 1 of this year. Prior to joining Millipore, Dr. Madaus was responsible for the Roche Diagnostics business in North America. Robert E. Knowling, Jr., has joined Immune Response's board of directors as chairman. Knowling may be best known for his career in telecommunications, including positions with Indiana Bell, Ameritech, US West and Covad. Santarus has named Michael G. Carter as an independent director. He retired from Zeneca, a publicly traded global pharmaceutical company, where he served as international medical director and international marketing director. Ann Reynolds, PhD, has joined Invitrogen's board of directors. Dr. Reynolds had been head of several universities, including the University of Alabama at Birmingham, the City University of New York, and the California State University system. Genstruct has appointed Michael R. Pavia, PhD, former chief technology officer of Millennium Pharmaceuticals, to its board of directors. Pharmacopeia Drug Discovery has elected Steven J. Burakoff, MD to its board of directors. He currently holds two prestigious academic appointments at the New York University School of Medicine: the Laura and Isaac Perlmutter Professor of Pathology and Professor of Medicine and Pediatrics. Hematech has appointed David L. Danley, PhD, to its board of directors. Dr. Danley brings to the board more than 20 years of experience in medical and biotech research as well as developing and managing biodefense initiatives for industry and the Department of Defense. Rafik H. Bishara, PhD, has joined Sensitech's board of directors and, in addition, will serve as a technical advisor to the organization. Unigene Laboratories has appointed Marvin L. Miller to its board of directors. He currently serves as executive chairman of Onconova Therapeutics and as a director of GTC Biotherapeutics and Tepnel Life Sciences.
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