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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioxcel, Calliditas, Histogen, Melinta, Oryzon, Pharmaessentia, Tetra.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA launches EUA safety dashboard; Fed Circuit claims mandamus jurisdiction in IPR institution; Comment period reopened on Orange Book patents.
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