Pharmaceuticals, Biotechnology and Life Sciences
Novartis has announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.
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.
Rentschler Biopharma and Vetter, two globally operating Contract Development and Manufacturing Organizations (CDMOs), have announced that the companies are unveiling Xpert Alliance, a joint visualization of their strategic collaboration.
The European Medicines Agency (EMA) has validated Bristol Myers Squibb-s type II variation application for Opdivo (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial.
Rejuvenate Biomed NV (“Rejuvenate”), a biomedical company developing novel combination drugs for age-related diseases, has provided an update on its development pipeline and strategy.
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.
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.