Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Aquestive, ARS, Astrazeneca, Cynosure Lutronic, Elevar, Exelixis, Galderma, GE, Incyte, Moonlake, Natera, OS Therapies, Pharming, Tuhura.
At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.
Lixa Pty Ltd. has formed a partnership with the Global Antibiotic Research & Development Partnership and announced a AU$28 million (US$20 million) series B round to take Neox-121 to the clinic to fight antimicrobial resistance.
Medtronic plc is continuing to put its money where its mouth is as it plans to exercise its option to acquire Cathworks Ltd. for up to $585 million. The company said last month it was committed to expanding its pipeline through strategic investments and targeted acquisitions. The move for Cathworks comes on the heels of Medtronic’s $90 million investment in Anteris Technologies Global Corp.
Following on from a successful phase IIa proof-of-mechanism study in myasthenia gravis, NMD Pharma A/S has added clinical data on a second neuromuscular disorder, reporting positive phase IIa results for ignaseclant, in both type I and type II Charcot-Marie-Tooth disease.
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