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…
Bristol Myers Squibb (BMS) has settled with Alembic Pharmaceuticals over allegations that Alembic’s proposed generic drug infringed on its blockbuster blood cancer drug Revlimid (lenalidomide). Source: Drug Industry Daily
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…
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…
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…
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…
Senate Democrats are advancing a long-awaited proposal for legislation that would allow Medicare to negotiate lower prescription drug prices. Source: Drug Industry Daily
The FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the oral antiviral drug to COVID-19 patients. Source: Drug…
Skyhawk Therapeutics, a three-year-old biotech spawned by entrepreneur, inventor and documentary filmmaker Bill Haney, has inked a new deal with Sanofi that has the two companies working together on challenging…
CureVac has filed a patent infringement lawsuit against BioNTech, claiming its messenger RNA (mRNA) technology was used without credit or compensation to create BioNTech’s and Pfizer’s Comirnaty, the world’s first…