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Merck’s new formulation of the mega-blockbuster Keytruda, made in collaboration with Alteogen, could help to keep the drug’s patent cliff at bay.
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Novo Nordisk goes “on the offensive” following Trump deal that also included rival Eli Lilly, putting an exclamation point on rapidly declining GLP-1 drug prices. Experts say the unusual situation makes it hard to predict what’s next.
Drug candidates don’t usually move among Big Pharma, but these five biotechs helped facilitate such hand-offs, scooping up assets from one pharma on the cheap before being bought out for billions by another.
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
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Merck, known as MSD outside of the United States and Canada, announced that new findings for efinopegdutide, an investigational GLP-1/glucagon receptor co-agonist, have been accepted for oral presentation at the European Association for the Study of the Liver Annual Congress from June 21-24.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Vertex unveiled long-term durability data for Casgevy, while Beam presented Phase I/II findings for its investigational base editor BEAM-101, building up to a BLA by late 2026.
Not developing potency assays and gaining knowledge about MOAs early in the drug development process not only can break ATMP success but can cause costs and delays that lead to company closures.
The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.
The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
The program has recently become controversial as a number of high-profile advanced approvals were granted only for the drugs to fail a confirmatory trial later on. Now, the FDA has clearly laid out expectations.
Protara is advancing a cell therapy that triggers both adaptive and innate antitumor immune responses, while CG Oncology’s approach makes use of an oncolytic immunotherapy that preferentially targets cancer cells and proliferates inside them, destroying them from the inside.
Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug.
It is not clear what specifically the new facility will produce, though Amgen could be ramping up its manufacturing capacity as it prepares to enter the obesity space with MariTide.
Iskra Reic will continue to serve as the pharma’s senior vice president for Vaccines and Immune Therapies as she steps in for Leon Wang, who was detained by Chinese authorities in November.