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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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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.
BioNTech will get CureVac’s early-stage cancer assets, including its mRNA-based glioblastoma therapy currently in Phase I development. CureVac had previously sued BioNTech for copyright infringement related to mRNA vaccine technology.
Nuvation Bio’s first approved product is Ibtrozi, a CNS-active ROS1 inhibitor that in pivotal studies showed high rates of treatment response in patients with non-small cell lung cancer.
The rehired staff, who number around 460, work with the CDC’s viral disease prevention efforts and sexual health testing labs, among others. The reinstatements are a ray of light in an acrimonious week that also saw protests and the complete overhaul of the agency’s vaccine advisory committee.
The eight new committee members replace the 17 Kennedy removed earlier this week. In “repopulating” the committee, the HHS Secretary fulfilled the fears of some analysts, naming scientists who appear to reflect his anti-vaccine views.