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Top biotech executives differ on health care law


[Boston.com] Top executives of the state’s two largest biotechnology companies offered diverging views today on the health care bill signed into law by President Obama, with one contending it protects innovation and the other insisting it does little to control costs. “I don’t think this health care reform really addresses the fundamental underlying issues that [...]

Biotechs find progress in vaccine market


[MHT] When it comes to vaccines, everyone now wants to get in on the action. That’s according to Paul Bogorad, a senior manager at pharmaceutical and biotechnology consultancy Putnam Associates in Burlington. Bogorad and other analysts say that the frenzy over H1N1 has heightened the public’s awareness of the difficulty of making vaccines and has [...]

Pfizer to pay record $2.3B penalty over promotions


[AP] Pfizer Inc., the world’s largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions, the Justice Department announced Wednesday. The department said the $2.3 billion settlement included a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture [...]

FDA Approves New Plan B Labeling


[WSJ] The Food and Drug Administration approved labeling that will allow 17-year-olds access to the Plan B emergency-contraceptive pill without a prescription.
The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over the counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, [...]

How we love those Drugs


[Mercury News] Last week a federal advisory panel recommended banning America’s most popular and effective prescription pain pills, including Percocet and Vicodin. Across the country howls were heard from doctors and patients suffering from everything from arthritis to toothache.
It’s no surprise that these pain relievers are considered dangerous. They contain powerful, habit-forming narcotics like oxycodone and [...]

Outsourcing of Drug Trials Is Faulted [NYT]


[NYT] As many American companies in the last decade have sent tasks like customer service and computer support to other countries, drug makers have followed suit by outsourcing clinical trials — the human studies that determine the safety and efficacy of medicines.
The New York TimesNow, an article about the globalization of clinical trials, published Thursday [...]

FDA to Open Inspection Office in China This Year


The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world.  FDA Commissioner Andrew von Eschenbach on Thursday laid out a plan to place more than 60 food and drug regulators world-wide [...]