BioSpace News Archive

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through status for ZYNRELEF.

Novavax, Inc. (Nasdaq: NVAX), today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine’s safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic.

Incyte (Nasdaq:INCY) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib (Jakavi®) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies.

INmune Bio, Inc. (NASDAQ: INMB) (“INMB” or “the Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reviews findings from data presented at AD/PD ™ 2022 - International Conference on Alzheimer’s and Parkinson’s diseases.

The Stock Split is contingent upon stockholder approval of a Restated Certificate of Incorporation that would increase the number of authorized shares of common stock from 200,000,000 to 800,000,000.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA.

Gardner Orthopedics, a recognized figure in orthopedic treatment and surgery located in Fort Myers, Florida, and Shalby Advanced Technologies, a division of Shalby Hospitals, headquartered in Ahmedabad, Gujarat, India, announced today an Indo-US collaboration to form Advanced Orthopedic Centres of Excellence at 11 multispecialty Shalby Hospitals in India and form Shalby Orthopedic Centres of Excellence in Fort Myers, Florida, and across India.

sanofi-aventis Canada Inc. announced the approval of Libtayo® for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody.

Oxurion NV, a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, published its annual report for the financial year 2021.