Speaking before a global audience of millions, President Barack Obama threw his support behind the potential of personalized medicine, skimping on details but hinting at a federally funded R&D effort in keeping with the $4.5 billion BRAIN Initiative.
The White House is temporarily shutting down biomedical research of dangerous pathogens, such as MERS, SARS and pandemic flu strains following several embarrassing safety incidents at government labs.
The Obama administration, under mounting pressure, intends to craft a policy for using experimental drugs to treat the Ebola virus, Reuters reports. The White House Friday said it is setting up a working group to consider the use of drugs on the hundreds patients in Africa infected by the deadly virus, which has killed nearly 1,000 so far.
Merck and GlaxoSmithKline have nixed their copay assistance for Obamacare patients. The two companies say they fear subsidizing patients' drug purchases will run afoul of federal anti-kickbacks law. But many other top drugmakers- including Novartis, Sanofi and Eli Lilly--will keep their copay cards and discounts, at least for now.
One of the signal achievements for the biotech industry in the Affordable Care Act was a provision granting 12 years of market exclusivity to biologics. The decade-plus period of protection against generic competition ensured that biologics would remain center stage in the R&D world, especially as Big Pharma tumbled over the patent cliff as it tried to rethink its megablockbuster-sized budgets for drug development.
Projects like the moon landing and the Human Genome Project, and now possibly BRAIN, will be among the hallmarks of our civilization, the tracks we leave on the sands of time. Undertakings of this scale and scope with payouts measured in the future of mankind exceed the resources of any individual, even a Bill Gates or a Paul Allen, and the largest research institutes and corporations, though their involvement enhances the program. So what is my concern regarding BRAIN? More >>
Grappling with major government budget cuts, the FDA is seeking remedies to preserve programs of vital interest to pharma and device companies. Now that sequestration has arrived today, power brokers in the White House and Congress could hold the keys to keeping the agency on track.
The rule for how drug and device makers will have to disclose their financial ties to doctors is 15 months overdue and the longer White House officials sit on it, the more lobbying it gets from different sides trying to shape its final wording.
Remember the Physician Payments Sunshine Act? If it's a vague memory, don't feel bad. The legislation that mandated disclosure of financial ties between industry and doctors is years old now. And because regulations to implement the act are 15 months overdue, it's not exactly front-of-mind for the average pharma-watcher.
The Obama administration wants the U.S. to figure out how to effectively treat and even prevent Alzheimer's disease by 2025, arguably a medical equivalent of President John F. Kennedy's challenge to