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As more and more groups call for the health secretary’s removal from office, senators will question Kennedy on his recent moves, including the controversial firing of CDC Director Susan Monarez.
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Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”
Big Pharmas like Eli Lilly, Sanofi and Novartis headed back to the dealmakers table multiple times, with 32 total deals counted across the industry for the first half.
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
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Amgen will host a webcasted call for the investment community at 1:00 p.m. PT on Monday, May 20, 2024 following the presentation of new data from TEZSPIRE® in chronic obstructive pulmonary disease at the American Thoracic Society International Conference on May 19 and 20, 2024.
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Read our takes on the biggest stories happening in the industry.
After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Sarepta’s troubles had nothing to do with Arrowhead’s assets, and yet both companies have seen their stock prices decline this past month. BioSpace caught up with Arrowhead’s Chris Anzalone to talk about the biotech’s role as an RNAi pipeline savior.
For $1.3 billion in aggregate—including upfront and milestone payments—Bayer will get exclusive global access to Kumquat Biosciences’ small-molecule KRAS G12D blocker.
The stop order came on Aug. 5, the same day Health Secretary Robert F. Kennedy Jr. terminated 22 mRNA vaccine projects under the Biomedical Advanced Research and Development Authority, though Vaxart’s candidate is protein-based.
The Annals of Internal Medicine ran a large-scale study in July, pointing to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions. The Health Secretary, in an opinion piece earlier this month, called the paper a “ballyhooed study.”
Leaders at Eli Lilly believe heavy investment in the company’s manufacturing footprint “sets a high standard that newcomers may find challenging to match.” At least one of those newcomers disagrees.
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
Gray Delany’s ouster comes days after Health Secretary Robert F. Kennedy Jr. controversially axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority.
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors.
An interview with Philip Vanek, chief commercialization officer of the International Society for Cell & Gene Therapy (ISCT), reveals both promising developments and significant concerns shaping the advanced therapies sector’s trajectory through 2025 and beyond. This interview was conducted with support from Tozaro.