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The FDA and the U.S. Patent and Trademark Office (PTO) will be walking the thin line between preserving patents as an incentive for groundbreaking drug developments and limiting them to allow the emergence of cost-effective generic forms of those drugs. Read More
The use of continuous manufacturing (CM) technology resulted in applicants getting FDA approval faster when compared to batch manufacturing products, according to an FDA audit published in the International Journal of Pharmaceuticals. Read More
Five Republican senators have called on the Senate Finance Committee to hold hearings on a proposed bill that aims to cap the cost of insulin at $35 a month before it is put before the full chamber for a vote. Read More
The FDA has accepted lecanemab — the potential heir to Aduhelm’s tarnished fortunes — into its Accelerated Approval pathway, giving the antiamyloid antibody a chance to put Biogen and Eisai back in the Alzheimer’s therapeutics race. Read More
A Democrat-sponsored bill could help solve some of the vexing problems that plague the FDA’s accelerated approval program, allowing it to still bring important new medicines to market quickly, but also increasing the agency’s ability to boot ineffective drugs off the shelves, according to a perspective published in The New England Journal of Medicine. Read More
Senate Democrats are advancing a long-awaited proposal for legislation that would allow Medicare to negotiate lower prescription drug prices. Read More