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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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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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Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Rubius Therapeutics plans to initiate a large restructuring initiative, which includes laying off 84% of its staff and a possible sale, the company announced Wednesday.
The executive shuffle continues across the biopharma industry as companies shore up leadership needs with these Movers & Shakers.
Cassava filed a lawsuit in federal court against individuals linked to a Citizen’s Petition filed with the FDA that raised concerns about data manipulation in a clinical study of simufilam.
Genentech made approximately 35 presentations at ECTRIMS involving blockbuster MS drug Ocrevus drug, with a focus on relapsing-remitting MS and continuing safety studies.
Regeneron called it quits on an experimental osteoarthritis pain treatment that has raised safety flags and an experimental antibody for cat-allergic asthma.
Abeona Therapeutics will head to the FDA next year for the potential approval of its experimental recessive dystrophic epidermolysis bullosa (RDEB) therapy following positive Phase III data.
Emalex Biosciences closed a Series D funding round Thursday counting $250 million in earnings, much of which will bankroll a Phase III trial of ecopipam for Tourette syndrome.
Exelixis has inked a licensing agreement with Catalent to gain access to three of Catalent’s target programs with antibody and ADC candidates, the companies announced Thursday.
Moderna is dropping an IL-12 program in autoimmune disorders after AstraZeneca returned the rights, the mRNA leader announced Thursday in its third quarter filing.