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Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.
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Price-negotiation provisions that are out of step with reality are discouraging funders and Big Pharma partners from investing in potentially transformative therapies. Fixing some of the unintended consequences of the IRA will clear the way for innovative medicines to reach patients in need.
Non-opioid pain therapies are entering an unprecedented era, marked by the landmark FDA approval of Vertex’s Journavx and a growing number of alternative approaches. Their ultimate uptake, however, remains to be seen.
With the modality now in early clinical trials, experts say more efficiency, broader editing capabilities and delivery breakthroughs are needed to propel RNA editing to the next stage.
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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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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.
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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.
The downsizing comes after a year of workforce cuts and reorganization for Roche’s subsidiary.
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.