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Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.
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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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Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.
The company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.
The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.
The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
The Swiss pharma is returning the anti-TGFβ antibody NIS793 to Xoma Corporation, from which it bought the asset in 2015 for $37 million upfront.
While an initial analysis showed improvements in progression-free survival and objective response rate, a second analysis saw no improvement in overall survival.
A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.
Wegovy’s highest dose significantly improved physical function and quality of life in obese patients with heart failure, according to results published Friday in The New England Journal of Medicine.