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The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.
FDA
Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
Warning signs that preceded the current economic squeeze in the biopharma sector were not heeded by investors seeking rapid profits. Now, biotechs interested in making the leap to the public markets must get creative.
Lupin Pharmaceuticals’ recall of Tydemy birth control is the latest in a string of problems with India-based generic drug manufacturers.
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.
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