Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S. Read More
The closely watched pivotal phase III trial called Stellar by Merck & Co. Inc. with sotatercept delivered in a big way for the company, helping to validate the firm’s $11.5 billion buyout about a year ago of Acceleron Pharma Inc. Read More
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua. Read More
In its case to a U.S. FDA advisory committee, the Center for Drug Evaluation and Research makes no bones about its dislike of Makena, (17-hydroxyprogesterone caproate), a drug for preventing miscarriages. It simply doesn’t work, the group maintains. Read More
Andera Partners closed its Biodiscovery 6 fund at €456 million (US$442 million). The venture capital firm will maintain its custom of allocating about two-thirds of the fund to biotechnology and one-third to medical devices and medical technology. The fund just edges past its target of €450 million. It is considerably larger than its immediate predecessor, Biodiscovery 5, which raised €345 million. Read More
Shares in Evgen Pharma plc more more than doubled in value after the biotech signed a deal worth up to $160.5 million with Stalicla SA, to develop sulforaphane-based drug SFX-01 for certain patients with autism spectrum disorder. Read More
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial. Read More
The Biotechnology Innovation Organization (BIO) confirmed Oct. 10 that its president and CEO, Michelle McMurry-Heath, is currently on leave from the trade group. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allogene, Clarity, Icosavax, Mersana, Octapharma, Oravax, Prolynx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beigene, Biontech, Evonik, Gennisium, Immune-Onc, Merck, Phathom, Pierre Fabre, Ridgeback, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Diurnal, Hugel, Knight, Lyell, Revive. Read More
