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Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.
The deal is an expansion of an existing production agreement between the companies and just one of several deals with large pharma companies that the Korean biotech has scooped up this year.
After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.
The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.
In the largest biotech Series C financing so far this year, Generate:Biomedicines raised $273 million, while Neumora and RayzeBio announced IPO pricing valued at more than $560 million combined.
The first annual BioTechX USA, held in Santa Clara in September, bridged the communication gap by bringing together life sciences leaders in all areas of the industry.
The Swiss pharma’s shareholders on Friday approved spinning off the generics and biosimilars division, with plans to launch at least five additional biologic drugs.
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.
While achieving FDA approvals in rare cancers such as multiple myeloma and diffuse large B-cell lymphoma, Karyopharm’s cancer drug has a variety of scientific and market hurdles to clear.
PRESS RELEASES
Shareholders Must Recast Their Votes to be Counted
Integration into McKesson’s Medical-Surgical Solutions marketplace serving a nationwide customer base
Phase I results provide platform-level validation supporting AdJane’s broader development programs in pandemic preparedness, respiratory infectious diseases and antimicrobial resistance
International experts from leading universities, global biopharmaceutical companies, and investment organizations will convene in Riyadh, Saudi Arabia, September 14–16, 2026, for the fourth edition of RGMBS.
Leinfelden, Germany. Recent infectious disease events—from hantavirus outbreaks and meningitis cases to recurring disease outbreaks in livestock farming—highlight the need for flexibly scalable vaccine manufacturing processes. To address this challenge, Stuttgart-based technology company KyooBe Tech has developed a platform designed to accelerate vaccine production. This technology is now also available to external users for studies at the Fraunhofer Institute for Cell Therapy and Immunology (IZI).
AmesNet’s Task-Conditioned Learning architecture outperforms FDA, MIT, Tencent, and the University of Sydney models in both sensitivity and balanced accuracy on out-of-domain chemical data on a public dataset; AmesNet is built on top of ChemPrint, the core and proprietary deep-learning engine of the GALILEO platform that powers the company’s drug pipeline.