The first U.S. case of the Omicron variant of COVID-19 was detected in California, top U.S. infectious disease expert Anthony Fauci said on December 1.
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Moderna Inc. could face a patent infringement lawsuit over the company’s COVID-19 vaccine after a federal appeals court on December 1 rejected its challenge to patents belonging to Arbutus Biopharma Corp.
Almost one year after Biogen forged a collaboration with Sage Therapeutics worth $1.52 billion, the development deal for the experimental major depressive disorder treatment zuranolone is bearing fruit that will support an expected rolling New Drug Application during 2022.
Moderna Inc. could have a COVID-19 booster shot targeting the Omicron variant tested and ready to file for U.S. authorization as soon as March 2022, the company’s president said on December 1.
Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The United States on December 1 identified the country’s first known case of Omicron, discovered in a fully vaccinated patient who traveled to South Africa, as scientists continue to study the risks the new COVID variant could pose.
The United States ordered airlines to hand over the names of passengers from southern African countries hit by the Omicron Covid-19 variant and other countries tightened their borders as a European leader urged people to “prepare for the worst.”
Vertex Pharmaceuticals reported the company’s Phase II proof-of-concept trial of VX-147 in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), with the drug hitting a statistically significant and clinically meaningful decrease of 47.6% in the urine protein to creatinine ratio (UPCR) at Week 13 compared to baseline.
Sanofi is expanding the company’s research into skin therapies after agreeing to acquire the Australian firm Origimm Biotechnology, which specializes in treatments for various types of skin diseases.
The White House said on December 1 the U.S. Department of Justice “will vigorously defend” the government’s authority to promote its vaccine requirement in federal contracting after courts blocked the Biden administration from enforcing two vaccine mandates.