| Today’s Big NewsMar 15, 2024 |
| By Angus Liu Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee still believe that the drug’s long-term benefits outweigh its risks. |
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By Max Bayer Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving US funding thus far, according to a regulatory disclosure. |
By Annalee Armstrong Madrigal Pharmaceuticals’ metabolic dysfunction-associated steatohepatitis drug has been approved, to be sold as Rezdiffra. For the other companies with up-and-coming treatments in the clinic, the question is: What now? |
By Kevin Dunleavy After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023. |
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Wednesday, March 27, 2024 | 10am ET / 7am PTThere can be numerous challenges encountered during biopharmaceutical process development. Join usfor an important look at formulation development specifically. Featuring real-world examples, this insightful discussion will explore key challenges, as well as the latest techniques and solutions for effectively overcoming current obstacles. Register now.
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By Conor Hale Intuitive Surgical has received an FDA green light for the fifth generation of its multiport da Vinci robot, following more than a decade of research and development. |
By Andrea Park As GLP-1 drugs like Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic and Wegovy have spent the last couple of years skyrocketing in popularity—with no signs of slowing down—it was perhaps only a matter of time before they further shook up the pharma industry. |
By Max Bayer Biogen CMO Maha Radhakrishnan has departed the company, a spokesperson confirmed. It was her second stint at the company after she rejoined in 2020. |
By Kevin Dunleavy Two months after Keytruda became the first PD-1 drug to be approved in the U.S. in combination with chemoradiotherapy (CRT) to treat patients with stage 3 to 4a cervical cancer, Merck’s superstar immunotherapy has strengthened its resume in the indication. A pre-specified interim analysis from the KEYNOTE-A18 trial shows that the combo regimen significantly improved overall survival versus CRT alone in patients with earlier-stage cervical cancer, the company reported on Friday. |
By Nick Paul Taylor Merck’s dominance of the PD-1/L1 checkpoint inhibitor space extends to the digital realm. That is the topline finding of a study of digital marketing trends, which found Merck has the highest traffic to patient and unbranded U.S. sites about non-small cell lung cancer (NSCLC). |
By Nick Paul Taylor Geron has triumphed in its latest uphill battle. Facing questions about the trade-offs of its blood cancer drug candidate imetelstat, the biotech won over an FDA advisory committee and secured a 12 to 2 vote in its favor—triggering a surge in its share price. |
By Conor Hale The goal will be to provide an end-to-end platform that applies extra-long nanopore sequencing reads to whole genomes—initially in order to help identify variants associated with rare diseases, before expanding the project’s scope into cancer testing. |
By Angus Liu Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf. |
Fierce podcastsDon’t miss an episode |
| | In this episode of 'The Top Line,' Fierce Biotech Senior Editor Annalee Armstrong interviews Karen Correa, Ph.D., from Takeda, discussing the crucial need for pharmaceutical companies to prioritize diversity in clinical trials. |
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Monday, April 22, 2024 | 10am ET / 7am PTExplore cutting-edge NASH research with a novel NAFLD/NASH animal model mirroring patient experiences. Witness Resmetirom's impact on fat accumulation using human cell-based in vitro models. Expect clinical relevance, quick insights in 12-16 weeks, and cost savings. Register now!
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| WhitepaperExplore the nuanced approaches necessary for successful pediatric drug development. Sponsored by: PPD |
| Whitepaper This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment. Presented by Blue Matter, strategic consultants in the life sciences |
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