Pharmaceuticals, Biotechnology and Life Sciences
Achieving classical herd immunity against SARS-CoV-2, the virus that causes COVID-19, may not be attainable, according to a new perspective published in The Journal of Infectious Diseases.
Abzena Thrusday announced a new round of investment. Funding sources for the additional $65 million include majority-owner Welsh, Carson, Anderson & Stowe (WCAS), Biospring Partners, and other affiliated investors.
US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s a 2.0 mg dose of Ozempic (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes.
Moderna, Inc. (NASDAQ:MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and adults 18 years of age and older with certain kinds of immunocompromise.
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) have announced the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone for DMD has been granted Fast Track Designation by the FDA.
Boehringer Ingelheim has announced new data from the pivotal Phase II Effisayil 1 trial, presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston.
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, has announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional.
GenNext Technologies, Inc., a growth-stage company providing biopharmaceutical drug discovery systems and services, has announced the receipt of a two year, Phase II SBIR grant for a project titled “In-Cell Automated Flash Oxidation (IC-AutoFox™) Protein Footprinting System.”
The US Food and Drug Administration (FDA) has approved Novartis’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer