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.
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.
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.
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.
Mirum Pharmaceuticals Inc. is buying privately held Bluejay Therapeutics Inc., an $820 million purchase that will bring it Bluejay’s lead asset, brelovitug, for treating chronic hepatitis D virus.
GSK plc said in paperwork filed with the U.S. SEC that the potentially whopping deal inked in the summer of 2020 with Ideaya Biosciences Inc. has gone down the tubes.
Viatris Inc. is padding its coffers with $400 million in cash through the sale of its equity stake in Biocon Biologics Ltd., which also involves $415 million in newly issued equity shares, for a total deal value of $815 million.
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