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Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
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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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U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Gilead’s Trodelvy ® for Pre-Treated HR+/HER2- Metastatic Breast Cancer.
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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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In a bid to improve competition in the industry, the U.S. Federal Trade Commission is challenging the patents of 20 different pharmaceutical products, disputing the accuracy and relevance of their patents.
Neurocrine Biosciences on Tuesday won the FDA’s approval for a sprinkle capsule formulation of Ingrezza, providing a more convenient route of treatment for Huntington’s disease patients with trouble swallowing.
This week’s legal losses by J&J and BMS reinforce the notion that Medicare drug price negotiation is here to stay, and investors continue to favor biologics over small molecules.
The FDA has cleared a clinical trial of an ex vivo prime editing candidate in patients with a rare disease, Prime Medicine announced Monday. The technique taps CRISPR technology to rewrite defective genes without breaking DNA double helix strands.
Under the latest teaming between the two companies, who have worked together since 2010, Novartis will pay $180 million upfront to PeptiDream to find new radioligand therapies.
Thanks to strong sales of its blockbuster drugs Mounjaro and Zepbound, Eli Lilly on Tuesday reported nearly $8.77 billion in revenue in the first quarter of 2024, while raising its full-year revenue guidance by $2 billion.
A federal court issued a summary judgment saying that the IRA provision does not represent an unconstitutional taking of property but did not rule on suits by Novartis and Novo Nordisk.
Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment.
On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug.