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After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
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Analysts parsed the limited data available for Pfizer’s obesity candidate on the pharma’s fourth-quarter earnings call Tuesday, looking for any nugget of additional context.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
BioSpace recaps 2024’s top venture capital rounds in biopharma, from Xaira Therapeutics’ blockbuster $1B raise to back-to-back series from obesity-focused Metsera that totaled more than $500M in a space that has garnered more than a fivefold increase in VC dollars this year.
The updated guidance, which was largely driven by lower-than-anticipated sales of GLP-1 blockbusters Mounjaro and Zepbound, sent Eli Lilly’s shares cratering by as much as 8% Tuesday, even as the company forecasted robust 2025 revenue.
Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry.
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.
The positive trial results could help Regeneron cushion the blow of its disappointing fourth-quarter sales for Eylea, which exceeded the consensus by a modest 1% and are bogged down by the slow conversion of patients to the high-dose formulation.