Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction. Read More
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Read More
Q32 Bio Inc. handed off rights to phase II-stage complement inhibitor ADX-097 in a deal with Akebia Therapeutics Inc. that helps the former extend its cash runway to focus on lead candidate bempikibart in alopecia areata and bolsters the latter’s efforts to build a rare kidney disease pipeline. Read More
Protego Biopharma Inc. closed an oversubscribed $130 million series B financing that will be used to advance PROT-001, the company’s treatment for amyloid light (AL) chain amyloidosis. a plasma cell disorder where the cells produce abnormal, misfolded immunoglobulin light chain proteins. Read More
The data from Inflarx NV that took Wall Street by surprise also served to heighten attention for the hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) spaces, where other news has been bubbling lately on the industry as well as scientific fronts. Read More
Both the FDA and the CDC’s Advisory Committee for Immunization Practices are on the threshold of revising how vaccines are approved and used in the U.S., but whether that opens to a precipice or a new era of stronger evidence and safer use is in the telling of the beholder. Read More
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS (UNAIDS) described “a global system in shock” by sharply reduced funding from the U.S. and other wealthy nations. Scientifically, for now, progress is ongoing. To mark World AIDS Day, Nature published three independent studies on HIV. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Anges, Biosidus, Mural, Prestige, RK, Roche, Vasomune, Xoma, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ascendis, Astrazeneca, Beone, Novo Nordisk, Otsuka, Sun. Read More
