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Latest From Michael McCaughan
Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.
Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.
PhRMA is endorsing dispensing limits on opioids and pledging to support a public/private partnership to develop new treatments and alternatives. But members of a Presidential Commission didn’t seem impressed.
Biopharma companies working on non-addictive pain drugs and new therapies to treat addiction had a high-profile platform during the most recent meeting of the President’s Commission on opioid abuse. Alkermes made the most of the opportunity.
The outcome of an US advisory committee review of PTC’s ataluren was not surprising. That is bad news for PTC’s prospects of launching the drug in the near term – but given the recent history of the DMD class, it is probably good news for biopharma companies overall as a sign that FDA's neurology group is moving forward effectively.
US FDA has shown it can be very flexible in expanding indications for a targeted therapy with a clearly established mechanism of action. But, as PTC Therapeutics learned, the agency’s willingness to apply mechanistic knowledge for targeted therapies cuts both ways.