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Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”
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The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.
On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.
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Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus standard of care in previously untreated adult patients with mantle cell lymphoma.
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Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
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Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S.
In December 2024, Dewpoint Therapeutics CEO Ameet Nathwani said the biotech’s cash runway would last until the third quarter of 2025.
The U.S. Preventive Services Task Force makes recommendations for preventive services—including Gilead’s twice-yearly HIV PrEP Yeztugo—that insurers must cover. A recently postponed meeting has raised concerns that Health Secretary RFK Jr. could abolish or overhaul the group.
There is no certainty that the buyout will come to pass, according to The Financial Times, which first reported the rumors.
From the price of forthcoming weight loss pill orforglipron, to Most Favored Nation drug pricing and the market battle with Novo Nordisk, pricing was the number one issue for Eli Lilly on its second quarter earnings call.
Higher competition for fewer roles remains the status quo for biopharma professionals, based on BioSpace data. Additionally, the U.S. Bureau of Labor Statistics has reported that recent job growth is lower than previously believed.
Strand Therapeutics’ lead asset is STX-001, an intra-tumor self-replicating mRNA therapy that carries a payload expressing the immunomodulatory protein IL-12.
Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ bear scenario for the oral med. Executives brushed off the concerns and said the drug will still have a wide advantage on the market.
Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.