Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celularity, Chinese Academy, Peptomyc, Precigen, Sangamo.
Responding to concerns about last-minute changes the Trump administration made to the Part D Payment Modernization Model for calendar year 2022, the Centers for Medicare & Medicaid Services (CMS) said March 16 that it is not moving forward with the formulary flexibilities that could have restricted Medicare patients’ access to necessary drugs.
A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Ambrx, Merck.
A new multilateral working group could bring deeper scrutiny to biopharma mergers, both past and future. The group, made up of competition experts from Canada, the EU, U.K. and U.S., is taking on the job of identifying fresh approaches to analyze and address the competitive concerns raised by biopharma M&As.
The latest global regulatory news, changes and updates affecting biopharma, including: TGA: VTE common, but not with vaccine; FDA looking at investigational labeling risks; ICER to review myasthenia gravis drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Arch, Corat, Cytocom, Meissa, Merck & Co., Pep-Therapy, Sagimet, Spectrum, Visus.
While World Trade Organization members continue to debate a proposal to waive intellectual property rights for COVID-19 vaccines and therapies, Biolyse Pharma Corp. is threatening to apply for a compulsory license of Johnson & Johnson’s one-dose vaccine through the Canadian Access to Medicines Regime.
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