The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed. Read More

The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA. Read More

The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit. Read More

Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25. Read More

Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased. Read More

A 24‑week pregnant woman fears for her unborn baby, who is developing with a sacrococcygeal teratoma so large and vascularized that it nearly surpasses the size of the fetus itself. Faced with this threat, surgeons operate inside the uterus in an open procedure that partially exposes the baby to remove the tumor and give the baby a chance to survive until birth. According to scientists presenting at the American Society of Gene & Cell Therapy's special meeting on Breakthroughs in Targeted In Vivo Gene Editing, this could be avoided. Read More

In October 2025, BioWorld tracked 252 clinical trial updates across phases I-III, roughly in line with September’s 230 but markedly higher than the 95 logged in August. Of those, 27 phase III studies reported positive results, while four disclosed failures. Clinical trial updates logged by BioWorld in October comprised 91 phase I reports, 75 from phase II, and 87 from phase III studies. Read More

BioWorld's offices will be closed in observance of Thanksgiving in the U.S. No issues will be published Thursday, Nov. 27, or Friday, Nov. 28. Read More

Managing Editor Anette Breindl talks about covering research breakthroughs that later became industry defining. Read More

Biopharmas raising money in public or private financings, including: Faron, Nuvalent, Pharmacyte, Tempest, Zetagen. Read More

Clinical updates, including data readouts and publications: Ascentage, Junshi, Novo Nordisk. Read More

Biopharma happenings, including deals and partnerships, and other news in brief: Geneditbio, Gilead, Liora, Lixte, Lunai, Psyence, Sprint, Toolgen. Read More

Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, BMS, Eisai, Innovent, Novartis, Otsuka, Regeneron, Sanofi, Sarepta, Teva. Read More