Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Quince Therapeutics Inc. is scrapping work with dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) for patients with ataxia-telangiectasia (A-T), and Boral analyst Jason Kolbert said “the core value driver has been effectively removed, and the equity appears fully impaired at this stage.”
Laborie Medical Technologies Corp. secured a new gem for its maternal health with the acquisition of the Jada system from Organon & Co. The terms of the deal, first announced in November, included payment of $440 million at closing, with an additional $25 million tied to 2026 revenue targets.
A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a problem qualifies as an adverse event. Perhaps of greater interest to companies in the organ container business is that the Centers for Medicare & Medicaid Services is intent on increasing the availability of organ donations to deal with an insatiable demand for donated organs.
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
Oncology-focused Eikon Therapeutics Inc. set the terms of its IPO Jan. 28, selling 17.648 million shares at a price range between $16 to $18 per share. At the top of the range, the Millbrae, Calif.-based biopharma company would raise about $317.7 million.
The presbyopia space gained another player as Tenpoint Therapeutics Ltd. won the U.S. FDA’s go-ahead for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%, previously known as Brimochol PF), the first and only dual-agent eye drop for the treatment of adult presbyopia.
In its fourth major biopharma deal since its 2019 founding, Repertoire Immune Medicines signed a partnership with Eli Lilly and Co. to develop tolerizing therapies for several autoimmune diseases, gaining an up-front payment of $85 million, with a potential $1.84 billion in development and commercial milestone payments coming later, along with tiered royalties.
En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.