Day two of the J.P Morgan Healthcare Conference rolled on with positive data from Sling Therapeutics Inc. that is leading the company to a phase III study in treating thyroid eye disease. The privately held company posted top-line efficacy and safety results from a phase IIb/III study of its lead candidate, linsitinib, which hits its primary endpoint with statistical significance at the twice-daily, 150-mg oral dose. Read More
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025. Read More
A global commission has proposed a fundamental change to the way obesity is defined and diagnosed. If the change is implemented, obesity would be considered a health risk in some contexts, and a disease in others. “The commission is reframing obesity... in a way that allows for the nuanced reality of obesity,” Robert Eckel told reporters at a press briefing announcing the proposal, which was published online in The Lancet Diabetes & Endocrinology on Jan. 14, 2025. Read More
In a deal potentially worth $810 million for Regenxbio Inc., Nippon Shinyaku Co. Ltd. is partnering on the U.S. and Asian development and commercialization of iduronate-2-sulfatase enzyme RGX-121 for Hunter syndrome and RGX-111 for Hurler syndrome. Read More
CSPC Pharmaceutical Group Ltd. on Jan. 13 gained the National Medical Products Administration’s approval of Shanzeping (prusogliptin tablets; DBPR-108) as a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor to treat adult patients with type 2 diabetes. Read More
Roche AG’s disclosure in December that prasinezumab, partnered with Prothena plc, fell short of its primary phase IIb endpoint put the spotlight on microtubule binding region (MTBR)-targeting therapies in neurological disorders. Read More
An experimental tuberculosis (TB) vaccine with a dual mission – self-destruction after inducing immunity – improved the design of the Bacillus Calmette-Guérin (BCG) immunotherapy, a vaccine also used against cancer. Scientists at the University of Pittsburgh engineered this strain with a double break, which is effective and safer after an intravenous administration, according to their results in nonhuman primates and mice. Read More
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender. Read More
Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions. Read More
The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Read More
BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025. Read More
BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the financing trends of the past year and the regulatory actions likely to affect med-tech into 2025. Read More
Biopharmas raising money in public or private financings, including: Ashvattha, Calidi, Immunis, Immunovant, Naya, Normunity, Tune, Verastem. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Sanofi. Read More
