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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.
Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
Depending on their needs, candidates can choose among tools such as AI-powered resume generators, professional coaches and university career services to hone their applications.
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.
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.
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.