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Thursday, July 10, 2025 | 10am ET / 7am PT The transition from drug discovery to process development poses significant challenges. Join us for this deep dive into how adopting a collaborative approach between medicinal and process chemistry teams can help address key obstacles and accelerate progress from discovery to early clinical milestones. Register now.
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Today’s Big NewsJun 25, 2025 |
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Thursday, July 22, 2025 | 10am ET / 7am PT Join us to take an exciting look at the forefront of REMS transformation. Learn how leading technology, integrated strategies and operational excellence are redefining what’s possible. Gain the insights you need to reduce complexity, enhance compliance and deliver more value across the REMS lifecycle. Register now.
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| By Fraiser Kansteiner With controversial presentation topics on the docket and the already abbreviated panel suddenly down one member, this week’s meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) is shaping up to be a long, strange two days. |
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By James Waldron Bayer-owned BlueRock Therapeutics is laying off 50 employees and shuttering its research labs in Cambridge, Mass., in order to focus its resources on its priority cell therapies, a spokesperson said. |
By Kevin Dunleavy What kind of uptake can Gilead expect for its long-acting HIV prophylactic injection Yeztugo, which was approved last week by the FDA? A HIV physician, who shared her views with analysts from Mizuho Securities, expects that a “majority” of her 125 pre-exposure prophylaxis (PrEP) users will switch to Yeztugo within the next 12 months, according to an investor note recapping the discussion. |
By Nick Paul Taylor Kymera Therapeutics sweetened news of a setback Wednesday, revealing that Sanofi is pulling back from its lead IRAK4 degrader alongside details of the selection of a follow-up prospect and a $750 million deal with Gilead. |
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The biologics development and manufacturing sector has long been at the forefront of innovation, consistently driving therapeutic advancements for a wide array of complex diseases. While demand has never been greater, there are still many technical challenges. This valuable resource uncovers how to navigate today’s top obstacles. Download now.
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By Angus Liu In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, the agency is investigating two Duchenne muscular dystrophy patient deaths following treatment with Sarepta Therapeutics’ Elevidys. |
By James Waldron Biogen has pointed to an early readout from a small phase 1 trial as evidence that its antisense oligonucleotide salanersen could help children with spinal muscular atrophy (SMA) who are still struggling to sit independently despite having received Novartis’ Zolgensma. |
By Conor Hale The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements. |
By Conor Hale Johnson & Johnson has teamed up with Nvidia and Amazon Web Services to make AI an integral tool in the OR. |
By Nick Paul Taylor Novo Nordisk is under fire over a Spanish obesity awareness campaign. After the campaign stirred up controversy, the Spanish ministry of health wrote to the drugmaker about a possible violation of drug advertising regulations. |
By Zoey Becker The commitment is part of a wider pledge to international vaccine alliance Gavi’s upcoming replenishment phase for 2026 through 2030. |
By Gabrielle Masson While the IPO landscape remains icy, Minovia Therapeutics is skating into the market using a special purpose acquisition company (SPAC) road. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," AbbVie’s Daejin Abidoye, M.D., joins us to discuss the future of antibody drug conjugates. |
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QPS leverages a combination of clinical and regulatory expertise, exceptional data scientists, and AI to deliver RWE studies that support accelerated drug development for biotech clients. Learn More.
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| WhitepaperWe analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance. Presented by Blue Matter, strategic consultants in the life sciences |
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