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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Ultragenyx and Mereo celebrated their first patient dosed in a Phase II/III study investigating the use of setrusumab as a treatment for osteogenesis imperfecta (OI).
The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
Seagen, Inc. and NovoCure Ltd. have each announced plans to open new facilities in the coming years, expanding local employment opportunities and respective presences in the biotech industry.
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
AbbVie, Novartis, Pfizer and other biopharma companies are ramping up support to Ukraine in the face of the continuing Russian invasion.
Gilead Sciences scored a legal victory regarding fraudulent HIV reimbursements, securing a court order against a number of clinics, labs and prescribers in Florida that were engaging in the alleged fraud.
The company brings to the arena bioengineered tissues that repair, restore or replace an organ or tissue functioning, called Tissue Therapeutics.