Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination showing an 83.4% rate of progression-free survival at three years vs. 29.7% for standard of care. Read More
Exicure Inc.’s buyout early this year of GPCR Therapeutics Inc. is paying off in a big way with data from the finished phase II trial testing burixafor (GPC-100). The agent is used with propranolol and granulocyte colony-stimulating factor to mobilize hematopoietic progenitor cells in patients with multiple myeloma (MM) undergoing autologous hematopoietic cell transplant. Read More
Immutep Ltd.’s stock surged 31% on Tuesday morning following the news that it out-licensed rights to Dr. Reddy’s Laboratories Ltd. to develop and commercialize eftilagimod (IMP-321, efti) in selected territories in a deal worth AU$528.4 million (US$349.5 million). Read More
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half. Read More
The UK Health Security Agency has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. Read More
Relation Therapeutics Ltd. will collaborate with Novartis AG in a $1.7 billion deal to develop multiple programs to find and advance targets for treating atopic diseases caused by immune dysregulation. Novartis will pay Relation an up-front amount, an equity investment and R&D funding of $55 million. It’s the company’s second deal with big pharma in the past 12 months. Read More
A month after besting rival Novo Nordisk A/S in a bidding war for obesity drug developer Metsera Inc., Pfizer Inc. is again adding to its GLP-1 arsenal, this time via a $2 billion licensing and collaboration agreement with Yaopharma, a subsidiary of China’s Fosun Pharmaceutical Co. Ltd. Read More
While the U.S. Congress has yet to address the artificial line it created between biosimilars and interchangeables when it passed the Biologics Price Competition and Innovation Act in 2010, the FDA is erasing that distinction for all practical purposes. Read More
The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ayrmid, Incyte, Junshi, Ocular. Read More
