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Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
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With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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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.
The biopharma job market failed to turn around in May, but employers were still hiring, especially in Indiana and California, based on BioSpace data. The two states had the most job postings live on BioSpace last month, with Indiana showing a 108% year-over-year increase.