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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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Early data from a combination of Cue Biopharma’s CUE-101 and Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.
PACT Pharma shared results of a first-of-its-kind trial using CRISPR technology to swap a gene in a patient’s immune cell to treat solid tumors.
At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
A trio of well-known biopharma executives invested $20 million in a Series A extension for San Diego’s Lipidio Pharmaceuticals.
The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer.
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
While Biogen and Seagen made the biggest C-suite splashes this week, other companies across the biopharma industry also bolstered their leadership teams with new talent.
After six months of searching for its next chief executive, Washington’s largest biotech firm has found its match. On Thursday, Seagen named David R. Epstein as CEO.
GSK and Sanofi veteran Christopher A. Viehbacher will take over as chief executive officer for Biogen. He replaces Michel Vounatsos, whose departure was announced in May.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.