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The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR Pharmaceuticals for use in up to five of Alexion’s gene therapies.
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Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
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Merck, known as MSD outside of the United States and Canada, announced that Merck for Mothers, the company’s global maternal health initiative, has reached more than 30 million women through programs promoting safe, high-quality, respectful care, surpassing its goal of reaching 25 million women by 2025.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta.
According to an internal email, the agency may be in for more consolidation in areas including human resources, communications, travel and acquisitions.
Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from acute liver failure, a known side effect of adeno-associated virus-based gene therapies.
AstraZeneca, Pfizer and more are leveraging the computational power of AI to better design trials, predict the potential efficacy and safety profiles of their molecules and synthesize massive multi-omic information to gain a more complete understanding of challenging cancers.
While cancelled NIH grants and regulatory uncertainty are less hospitable to clinical research in the U.S., Europe must play its cards right to attract more studies.
Later this month, HHS Secretary Robert F. Kennedy Jr.'s revamped CDC vaccine advisory committee will discuss RSV vaccination guidelines for the newly approved patient group, high-risk adults 18 through 49. Analysts and other experts have warned that the new panel includes some who have documented anti-vaccine sentiments as well as those who have spoken out against mRNA technology specifically.
Friday’s deal with CSPC fits neatly within AstraZeneca’s business development strategy of upping investments in AI and in China.
Martin Kulldorff and Robert Malone, both outspoken vaccine skeptics, have received compensation for their expert participation in various vaccine-related cases against Merck.
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Scientists and analysts express concern that the newly appointed ACIP members—which include known anti-vaxxers—could relitigate recommendations that have already been made. Many are imploring Sen. Bill Cassidy to step up.