News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
Arcus Biosciences and its collaboration partner Gilead Sciences announced during Arcus’ third-quarter report that the company had modified its ARC-10 Phase III trial.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
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.