With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV. Read More
Stable disease in about half the patients tested wasn’t enough for Wall Street, and shares of Vincerx Pharma Inc. (NASDAQ:VINC) nosedived by $3.72, or 78%, to close April 9 at $1.06 on the disclosure of preliminary phase I data with small-molecule drug conjugate VIP-236 in metastatic solid tumors. Read More
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases. Read More
Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies. Read More
A day after investing $40 million in China’s D3 Bio Inc., London-based venture capital firm Medicxi is investing $25 million to co-found a new U.K.-based company called Petalion Therapeutics Ltd. that will focus on an early stage oncology asset from Australia’s Starpharma Holdings Ltd. to develop novel dendrimer-based treatments. Read More
The biopharma sector secured $13.84 billion in financings in March, marking a 38% decline from February’s $22.3 billion, yet a 27% increase from January’s $10.9 billion. In 2023, biopharma financings averaged $5.91 billion per month. March brought two biopharma IPOs, totaling $2.65 billion, driven by Galderma Group AG’s inaugural offering of more than $2 billion. Read More
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years. Read More
New hires and promotions in the biopharma industry, including: Artios, Asklepios, Astria, Bioage Labs, Curevo Vaccine, G.ST Antivirals, Oncozenge, Opthea, Plus, Tela, Xencor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Antibe, Basilea, CASI, ICER, Juventas, Lonza, Medincell, Milestone, Nanoform, Neurosense, Nuance, Nurix, Nvelop, Plusvitech, Sanofi, Transcenta, Varian, Windtree. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Delta-Fly, Janssen, Junshi, Ocugen, Oryzon, Shorla, Stealth, Supernus, Viiv. Read More
