The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space. Read More
In June 2023, biopharmas collectively raised $6.82 billion through 109 financing transactions. The amount raised is 32.95% more than last June’s $5.13 billion, and the number of transactions is up 26.74%, compared to 86 in June 2022. This echoes the 23.34% increase seen in financings in the first half of 2023 compared to last year. Read More
Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market. Read More
After 50 years of censorship, there is now growing pressure on EU policymakers to stand up and play a role in promoting the development of psychedelics as medicines and in preparing the ground to ensure equitable access once there are approved products. Read More
Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD). Read More
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allarity, Aslan, Biodexa, Celldex, Eli Lilly, Horizon, Novavax, OSE, Pfizer, Photocure, Revive, Simcha, Tolerogenixx, Ultragenyx, Vaxart, Verastem. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan. Read More
