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While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked reduction in body fat. Biohaven plans to launch a Phase II trial in obesity by the end of the year.
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The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
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Bristol Myers Squibb Canada (BMS) today announced that Health Canada has approved SOTYKTU (deucravacitinib tablets), the first-in-its-class oral tablet for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches.
Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.”
The European Commission has tagged India-based pharma Alchem as being part of a global cartel that coordinates the pricing of a pharmaceutical ingredient in the antispasmodic drug Buscopan.
The U.S. Supreme Court on Thursday upheld access to the abortion pill mifepristone, unanimously rejecting a challenge by a group of anti-abortion doctors seeking to undo the FDA’s approval of the drug.
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
Moderna said Thursday it plans to talk to regulators about the next steps after showing its next-generation candidate is more efficacious in adults than the biotech’s existing Spikevax COVID-19 shot.
Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.
With Versant Ventures as a founding investor, Santa Ana Bio emerged from stealth Thursday with $168 million in combined Series A and B funding to support plans to have two programs in the clinic by next year.
Results of a large Stanford Medicine study, published Wednesday in The New England Journal of Medicine, finds CAR-T therapies carry a low risk of secondary malignancies not related to the T cells.
Coherus BioSciences and Junshi Biosciences’ PD-1 inhibitor Loqtorzi significantly boosted progression-free and overall survival in a late-stage study of patients with advanced hepatocellular carcinoma.