CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.
The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptamer, Belmont Medical Technologies, Bioiq, Cytosorbents, Diamir, Emulate, Interpace, GE Healthcare, Leinco, Magventure, Mologic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA sets up webpage, template for screening; Stryker’s STAR ankle exhibiting fracture risk.
LONDON – Exevir Bio NV added a further €15 million (US$17.9 million) to close its series A round at €42 million, providing the means to take its nanobody therapy for treating COVID-19 infection through to registration.
Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.
