The U.K.’s medicines and vaccines manufacturing environment needs a complete overhaul, with the worrying decline in exports and investment in the country addressed, if the UK is to beat global competition, the Medicines Manufacturing Industry Partnership believes.
Biomedical Research & Bio-Products (Bio&Bio) AG is laying plans for a phase III trial of its vaccine for preventing methicillin-resistant Staphylococcus aureus infections from sparking toxic shock syndrome, after delivering phase II data showing good safety and immunogenicity. Read More
Privately held Vivacelle Bio Inc. has completed its phase IIa study of VBI-S in treating septic shock patients with severe hypovolemia, a drastic drop in blood pressure that can lead to organ failure and death. In the study, VBI-S, an intravenously injected fluid composed of phospholipid nanoparticles, increased blood pressure and improved organ function. Read More
Emerging biopharma company Mineralys Therapeutics Inc. priced a $192 million upsized IPO, the biggest so far this year, following positive top-line phase II trial results it announced for its lead hypertension candidate lorundrostat in November last year. Read More
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea. Read More
Leveraging ferroptosis, or iron-mediated cell death, Hillstream Biopharma Inc. has turned up intriguing early stage data in non-small-cell lung cancer (NSCLC) when the company’s candidate called HSB-1216 was paired with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.). Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artios, Awkn, Biomedical Research & Bio-Products, Cara, Celyad, Cognition, Eiger, Galapagos, Immvira, Kite, Kura, Nexcella, Redx.. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allegro, Ascend, Cube, Eliem, Ensoma, Freeline, HBM, Mythic, Nona, Nimbus, Nykode, Sunshine, Takeda, TLS, Twelve Bio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bellerophon, Medicinova, Mesoblast, Regeneron. Read More