Citius Pharmaceuticals Inc.’s retooled version of withdrawn cancer drug Ontak (denileukin diftitox) is not quite ready for prime time, according to the U.S. FDA, which issued a complete response letter (CRL) for the interleukin-2-diphtheria toxin fusion protein known as Lymphir. The agency is asking for Citius to incorporate enhanced product testing and additional controls but did not raise any concerns regarding safety and efficacy, the company said. Read More
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia. Read More
Positive top-line phase II results caused Mymd Pharmaceuticals Inc.’s stock (NASDQ:MYMD) to surge 31.8% on July 31 to close at $1.45 per share. The data behind the push were for MYMD-1 (isomyosmine) for treating chronic inflammation associated with sarcopenia. Read More
South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial. Read More
The notion of taking aim at the galectin pathway across varied therapeutic areas has gained major traction in recent years, with a handful of companies drawing Wall Street’s interest as efforts plow forth in conditions as varied as cancer, liver fibrosis and Alzheimer’s disease. Read More
Biopharmas raising money in public or private financings, including: ABVC, Alvotech, Checkpoint, Cyclerion, Okyo Pharma, Oncolytics, Tisento. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Belite, Chinook, Cullgen, Genenta, Homology, Immutep,
IO Biotech, Merck, Synthekine.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Amarin, Astrazeneca, Biontech, Chiesi, Dare, Instadeep, Ionish, Lotus, Mithra, Orion, Pfizer, Riparian, Santhera, Searchlight, Siga. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Gilead, Keros, Peptomyc. Read More
