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The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
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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.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
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Takeda presented favorable interim results from a global pivotal Phase 3 randomized, controlled, open-label, crossover trial evaluating the safety and efficacy of TAK-755 replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura, and pharmacokinetics characteristics of TAK-755, as well as long-term data on TAK-755 prophylaxis from a Phase 3b continuation study.
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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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Other notable greenlights this year include Bristol Myers Squibb’s Cobenfy, the first novel therapeutic for schizophrenia in 35 years, and Madrigal Pharmaceuticals’ Rezdiffra, the first-ever treatment for MASH.
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion in 2023. It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic.
The mega-blockbuster weight loss GLP-1 drug is now also approved to treat obstructive sleep apnea in adults with obesity, in combination with diet and exercise.
High profile failures and long timeframes for revenue have shifted investment away from Phase I, as VCs seek to mitigate risk, Pitchbook said in its 2025 outlook.
Following a 90% drop in share price due to an FDA rejection and a warning letter over Applied Therapeutics’ conduct during a clinical trial, the biotech’s CEO has stepped aside.
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space.
Already established as cornerstone therapies in diabetes and obesity, GLP-1 receptor agonists also show potential in several other indications, including cancer, addiction and neurodegenerative diseases.
Novo Nordisk executives set a high bar for itself when it projected CagriSema could achieve 25% weight loss. When the GLP-1 combo didn’t hit that mark, investors reeled.
Galectin’s shares tanked in premarket trading Friday after the biotech revealed its lead asset missed the primary endpoint for its Phase IIb/III trial for patients with a type of liver cirrhosis.