If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apstem, Asieris, Avrobio, Genprex, Insignis, Mesoblast, Oncosec, Pepromene, Rafael, Regeneron, Tricida.
With the world heading straight into a "very tough" stretch of the COVID-19 pandemic in which "too many countries are seeing an exponential increase in cases," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus, two lucrative deals announced Oct. 28 showed little slack in efforts to confront the virus, even as evidence is still developing.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Astellas, Astrazeneca, Daiichi Sankyo, Insmed, Passage, Qualigen, Revision, Taysha Gene Therapies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allergan, Alx, Ampio, Aurinia, Boehringer, Castle Creek, Clinuvel, Finch, Galera, Gyroscope, Highlight, Orasis, Mediwound, Regentree, Therapeutics Solutions.
LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers.
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