Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
The lively antibody-drug conjugate (ADC) space chalked another collaboration as Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing agreement worth as much as $1.03 billion with Ipsen SA, of Paris, for antibody-drug conjugate FS-001, which is said to bear first-in-class potential. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said.
Nonalcoholic steatohepatitis was renamed, for the first time in 34 years, to metabolic dysfunction associated steatohepatitis (MASH), but a name change is far from being the biggest development in the field, according to experts at Bioplus Interphex (BIX) Korea 2024.
Silicon Valley-based Biomap is setting up a new global biocomputing innovation hub, dubbed Biomap Innohub, in Hong Kong as the local government ramps up investment to build supercomputing prowess, Vicky Qu, senior vice president of Biomap, told BioWorld. The goal is to accelerate novel drug product development and commercialization with biocomputing.
Kazia Therapeutics Ltd.'s stock shot up 248% on July 10 after the Sydney-based company reported that paxalisib showed a 3.8-month improvement in overall survival, a 33% improvement, for newly diagnosed unmethylated patients with glioblastoma (GBM) compared to the concurrent standard-of-care arm in the pivotal GBM-Agile phase II/III study.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Arcutis, Curium, Longeveron, Pharmassêtx.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Context, Cosette, Ensol, Esteve, Evotec, Link, Oragenics, Perrigo, Pfizer, Smartcella, Spine, Xylocor.
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