Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Genmab, GSK, Halozyme, Sarepta, Terns, Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC, Astrazeneca, Axon, Brink, Clinuvel, Cmab, Cobra, Combigene, Fresenius Kabi, Gain, Generate, Havn, Immunomic, Immunoprecise, Kempharm, Know, KVK-Tech, Laekna, Ligand, Nabriva, Orion, Rockwell, Sumitomo Dainippon, Totient.
Vaccine hesitancy could slow the development of herd immunity for COVID-19 in the U.S., but there could be other ways to help reach it. Testifying at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9, Surgeon General Jerome Adams said the numbers needed for herd immunity vary from expert to expert, but it ranges from 60% to 80% of the population.
The Lifetime Initiative released a roadmap to revolutionize health care in Europe by implementing cell-based interceptive medicine in a perspective article published Sept. 7 in Nature.
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alydia Health, BD, Dreamed Diabetes, Sight Sciences.
With phase III COVID-19 vaccine trials each enrolling 30,000 participants or more in the U.S. and randomizing half of them to a placebo arm, only 150 incidents of the coronavirus infection are needed in a trial to show if the vaccine is at least 50% effective, NIH Director Francis Collins testified at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9.
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