Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ayrmid, Incyte, Junshi, Ocular.
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.
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).
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.
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.
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.