During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said. Read More
LONDON – Six weeks on from the initial alert, “the window of opportunity” to control the COVID-19 epidemic is “narrowing,” according to the latest assessment from World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus. Read More
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market, a Nasdaq-style tech board, to reap $241 million at a valuation of almost $2 billion. Its share price soared more than 83% during its first trading day. Read More
DUBLIN – Adrenomed AG disclosed Feb. 21 that its first-in-class antibody, adrecizumab, hit the primary safety and tolerability endpoint of a phase II trial in septic shock. Read More
Valrox (valoctocogene roxaparvovec) from San Rafael Calif-based Biomarin Pharmaceutical Inc. moved one step closer to entering the U.S. market, with the company reporting that that the FDA had accepted for priority review the BLA for its investigational AAV5 gene therapy for adults with hemophilia A. Read More
HONG KONG – Beijing-headquartered Canbridge Pharmaceuticals Inc. has completed a $98 million series D financing round to target rare genetic diseases in China, and is considering an IPO after several rounds of financing to further pursue its goal. Read More
HYDERABAD, India – To continue expanding their footprint and capabilities beyond simple generics to biosimilars and new chemical entities, Indian pharmaceutical companies will have to improve their quality controls, compliance capabilities and, just as importantly, adopt more effective digital strategies. Read More
Less than a month after landing a positive opinion from the EMA's CHMP, Esperion Therapeutics Inc. has won FDA approval for bempedoic acid as an adjunct to diet and maximally tolerated statin therapy. Read More
BioWorld looks at translational medicine, including: Noncoding RNA protects blood vessel walls; PD-1 blockade interferes with opioid analgesia; T-cell population is biomarker for beta cell function; Glutaminase 1 is NASH target; Oligodendrocyte-neural connections not just about myelin; Sharper look yields new potential kinase target in ovarian cancer; Structural insights could enable specific activation of GPCRs; Autophagy activation may prevent metastasis; AI finds structurally unique antibiotics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Actinium, Adrenomed, Ampio, Cytodyn, Genfit, Harbour, Intra-Cellular, Nono, Transgene. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aradigm, Arch, Beijing Innocare, Cyclica, Erytech, Genetron, Grifols. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baudax, Biomarin, BMS, DBV. Read More
