In 2020, the Conference on Retroviruses and Opportunistic Infections (CROI) was the first medical conference to go virtual, with two days advance warning, when news of infections resulting from a Biogen Inc. conference with about 150 attendees made it abundantly clear that SARS-CoV-2 was circulating, well, probably everywhere.
DUBLIN – Grifols SA is acquiring Gigagen Inc. outright by paying $80 million for the remaining 56% of the company’s equity it does not already own. Its total outlay comes to $115 million, as it had previously acquired a 35% stake in South San Francisco-based Gigagen back in 2017.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Affibody, Alphamab, Altrubio, Amylyx, Cyclo, Huya, Inmagene, Melior, Oncopeptides, Rocket.
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
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