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Despite having no definitive data, Sen. Ron Johnson (R-WI) in a letter to health secretary Robert F. Kennedy, Jr. suggested there was a conscious effort by the Biden administration’s FDA to cover up the safety risks of COVID-19 vaccines.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Examining 50 existing drugs, researchers find that the IRA could cause drug developers to shy away from pursuing subsequent indications for their marketed drugs, thereby reducing the number of new approvals.
Companies inked 204 deals in the fourth quarter of 2023 with venture capital funding slipping to $6.3 billion from $7.8 billion in the third quarter last year, according to market data firm Pitchbook.
After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
Varoglutamstat, a drug developed by German biotech Vivoryon Therapeutcs, did not hit its primary and secondary endpoints in a Phase IIb study in Alzheimer’s disease.
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease.
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The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
FDA
Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.
Exosomes show potential to treat myriad conditions, including cancer and inflammation, but experts are divided on whether the therapies are ready for the limelight.
As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
Pfizer’s oncology strategy to build up its biologics portfolio and dramatically reduce small molecules was influenced by the Inflation Reduction Act’s drug price negotiation provisions.