Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution. Read More
Actuate Therapeutics Inc. said its lead candidate, elraglusib, in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to convince investors. Read More
Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy. Read More
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration. Read More
Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court. Read More
In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients. Read More
U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies. Read More
New hires and promotions in the biopharma industry, including: Biontech, Biovie, Innospera, Mammoth, Mendus, Rakovina, Rose Hill, Tharimmune. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptose, Chemomab, Eupraxia, Immutep, Janus, J&J, Nanobiotix, Opus, PTC, Recursion, Regeneration, Spyre, Theralase, Unity. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alterity, Alvotech, Capricor, Ichnos, Immunitybio, Novo Nordisk, Rezolute, Teva, Vanda. Read More
