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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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The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.
Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint.
Noubar Afeyan, founder of Flagship Pioneering and Moderna, spoke at an event hosted by the Institute of Global Health Innovation.
With COVID-19 still very much a threat to the public, researchers are working on developing new treatments. Read on for more updates.
Patient deaths associated with Astellas Pharma’s gene therapy candidate underscore the risks of developing potential one-and-done treatment options for serious diseases.
WHO is raising flags against the concerns surrounding a mysterious illness (related to pediatric liver disease) that is increasing following a reported death.
One of the most common types of leave is family leave, and navigating it can be a long, arduous process. To help, we’ve created a guide to answer your questions about family medical leave.