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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Read our takes on the biggest stories happening in the industry.
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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AbbVie’s investigational neurotoxin, designed to prevent postoperative atrial fibrillation, missed the primary endpoint in a Phase II trial, the company announced Monday.
Sensorium Therapeutics, which closed a $30 million Series A Tuesday, is embracing the complexity of neuropsychiatric diseases with nature-inspired psychoactive medicines.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Biopharma’s efforts to conquer immunoglobulin A nephropathy were on full display at ASN’s Kidney Week as Ionis, Chinook and Vera all reported positive data.
Eye specialist Oyster Point Pharma announced is being acquired by Viatris Inc. after Oyster’s board of directors unanimously signed off on the deal, Oyster Point announced Monday.
GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.
The only patient in an FDA-sanctioned clinical trial assessing a CRISPR-based therapy for a rare form of Duchenne muscular dystrophy has died, according to study sponsor Cure Rare Disease.
Eli Lilly’s and Boehringer’s Jardiance met its primary outcome in the Phase III EMPA-KIDNEY study, the largest and broadest SGLT2 inhibitor trial in chronic kidney disease.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
In spite of positive Phase IIb results from a thrombosis prevention trial, Ionis is back on the market for a new partner after Bayer returned the rights to the drug to Ionis.