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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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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
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10x Genomics announced it will report financial results for the third quarter 2022 after market close on Wednesday, November 2, 2022.
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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 Atlanta area is receiving more physical real estate options to foster its burgeoning biotech industry.
Despite being hit with a 20% sales decline due to a plunge in demand for its COVID-19 products, Pfizer on Wednesday reported $14.88 billion in revenue in the first quarter of 2024, exceeding analyst expectations.
J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.
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.