Sanofi and Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd., have announced promising results from the RELIEVE UCCD phase 2b study, which met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD). The study…
GSK plc has announced that ViiV Healthcare, the global HIV-focused company majority owned by GSK with Pfizer and Shionogi as shareholders, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…
Grifols, a global healthcare leader and prominent manufacturer of plasma-derived medicines, has achieved the distinction of being ranked the number one biotechnology company in the S&P Dow Jones Sustainability Indices (DJSI). This marks the company’s fifth consecutive year in the…
Lupin Limited, a leading global pharmaceutical company, has announced the acquisition of three key anti-diabetes trademarks—GIBTULIO®, GIBTULIO MET®, and AJADUO®—from Boehringer Ingelheim International GmbH. This strategic move is aimed at strengthening Lupin’s diabetes portfolio in India. According to the terms…
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending acoramidis for marketing authorization in the European Union (EU). Acoramidis is a selective, orally administered small molecule designed to…
Eli Lilly and Company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Omvoh® (mirikizumab) for approval. Omvoh, an interleukin-23p19 (IL-23p19) antagonist, is proposed for the treatment of…
AbbVie has announced a definitive agreement to acquire Nimble Therapeutics, a biotech company specializing in the discovery and development of innovative oral peptide therapies. This acquisition includes Nimble’s lead investigational oral peptide IL23R inhibitor, currently in preclinical development for psoriasis…
Merck known as MSD outside the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional approval of WELIREG® (belzutifan), an oral hypoxia-inducible factor-2…
Celltrion has announced that Health Canada has approved Omlyclo™, the first and only biosimilar referencing Xolair® (omalizumab) in Canada. Omlyclo™ is now authorized for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also known as chronic spontaneous…
SK pharmteco, a global leader in contract development, manufacturing, and analytical testing services for the pharmaceutical and cell & gene therapy industries, has announced a groundbreaking brand unification initiative. This strategic effort consolidates the expertise and capabilities of several renowned…
AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) and granted it Priority Review. The application seeks approval for IMFINZI as a treatment for patients with muscle-invasive bladder…
Today, the European Commission officially approved the acquisition of Catalent, Inc. by Novo Holdings A/S, a deal that will further expand the capabilities of the Novo Group. Catalent, a global leader in contract development and manufacturing services based in New…