Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icad, Imbio, Inspire Medical Systems, Medtronic.
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.
The U.S. Centers for Medicare & Medicaid Services (CMS) has imposed a 60-day delay in the implementation of the Medicare Coverage of Innovative Technologies (MCIT) program, stating that the MCIT draft rule was developed under a flawed assumption about the volume of eligible breakthrough devices. CMS said the situation suggests that the public did not have an appropriate opportunity to comment on the proposed rule, a predicament that suggests the possibility that the MCIT program might not survive the Biden administration’s regulatory review.
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA comments on two patent term extensions; Comment period reopened on Orange Book patents.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
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.
RSS
