Investors have known for some time that the GLP-1 receptor agonist class offers tremendous promise for treating the underserved obesity population worldwide, but news from Novo Nordisk A/S on cardiovascular outcomes data sent a shiver throughout the space on Aug. 8. Top-line results from the Select trial comparing subcutaneous once-weekly Wegovy (semaglutide) 2.4 mg with placebo showed the treatment reduced major adverse cardiovascular events by a statistically significant 20%. Read More
Astex Pharmaceuticals Inc. is getting $35 million up front and up to $500 million per program as it extends its drug discovery collaboration with Merck & Co. Inc. to include small-molecule activators of the p53 tumor suppressor protein. The number of programs was not disclosed, but they will target forms of p53 that have lost their function as a result of cancer-induced mutations in the TP53 gene. The aim will be to override the mutation and restore the ability of the wild-type protein to bind DNA and perform its functions as a transcription factor. Read More
Gracell Biotechnologies Inc. stands to gain up to $150 million from an assorted bouquet of private U.S. health care investors to lay a solid foundation for clinical trials of its leading dual-targeting CAR T-cell candidate, GC-012F, and provide a cash runway into the second half of 2026. Read More
Biopharmas raised $5.87 billion through 96 financings transactions in July 2023. The total amount raised is similar to the first six months of 2023 average of $5.48 billion per month, ranging from $3.74 billion in February to $8.02 billion in March of this year. Including July, the 2023 monthly average of money raised in all transactions is $5.46 billion. Read More
South Korean biopharma Connext Co. Ltd. is set on outdoing standard-of-care therapies for Dupuytren’s contracture. The Daegu-headquartered Connext recently secured U.S. FDA IND approval for a phase I/II trial on its recombinant collagenase clostridium histolyticum, called CNT-201, inching closer to its goal of providing an affordable but high-quality therapeutic option for patients with the rare, progressive connective tissue disorder. Read More
A logjam of clinical trial applications that has bult up at the U.K. Medicines and Healthcare products Agency (MHRA) is deterring companies from conducting studies in the U.K., according to the Bioindustry Association. Read More
Building on capabilities developed during the COVID-19 pandemic, the U.K. Health Security Agency’s Vaccine Development and Evaluation Centre hit the ground running. Read More
Calling it a “landmark judgment,” the U.K.’s Competition and Markets Authority welcomed the Competition Appeal Tribunal’s Aug. 8 unanimous decision upholding an £84 million (US$107 million) fine levied against London-based Advanz Pharma Corp. for excessive drug pricing. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Apogee, Bavarian Nordic, Halia, Humanigen, Nektar, Passage, Praxis, Tonix, Vistagen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Bayer, Cardiff, Emergent, Fibrogen, Formycon, Fresenius, J&J, Kiora, Neopharm, Oramed, Scilex, Sorrento, Sparian. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascentage, Biocity, Biogen, Huidagene, Impact, Iveric, Jacobio, MBX, NS, Rhythm, Viatris. Read More
