The U.S. National Institutes of Health reported Oct. 14 that it has awarded contracts in the amount of $77.7 million for development and manufacture of a dozen new rapid tests for the SARS-CoV-2 virus. The monies were awarded under the NIH’s Rapid Development of Diagnostics (RADx) program, and will add seven viral antigen detection and five viral RNA detection tests to the suite of offerings. all with an eye toward more rapid turn-around of test results. The news of the new round of RADx grants was followed by 24 hours the announcement that the Department of Health and Human Services has extended the public health emergency (PHE) for the COVID-19 pandemic for another three months.
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Histosonics, Thermo Fisher Scientific.
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Astrazeneca, Eli Lilly, Medigen, Merck, Protalix, RDIF, TG.
The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andau Medical, Detect, Ganymed Robotics, Milestone Scientific, New Al Farwaniya Surgicals and Medical Equipment, Pathai, Roche, Sanolabor.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biothera, Pharmapark, Shortwave, Treadwell, Vaxil and Xortx.
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
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