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
Ready for doc-payment disclosure rules in the U.S.? They've been promised for years now, ever since Sen. Charles Grassley and his cohorts started hammering on drugmakers' payments to physicians,
The U.S. Supreme Court has the chance to make it easier for generics makers to fight against certain patent protections--or to make sure branded drugmakers have to face certain challenges at all. The
The Obama administration is wading into the drug-shortage fray. The president plans to sign an executive order that aims to alleviate scarcity of many important drugs, including key cancer therapies,