Awaiting the potential U.S. FDA approval of a second product this year, Protagonist Therapeutics Inc. with partner Johnson & Johnson won the go-ahead for oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, to treat moderate to severe plaque psoriasis in adults and pediatric patients 12 and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy. Read More
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act. Read More
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history. Read More
Imperative Care Inc. secured $100 million through an oversubscribed convertible note financing round to support commercialization of its stroke and vascular thrombectomy technologies. The round was co-led by new investors Elevage Medical Technologies and Perceptive Advisors alongside existing investor Catalio Capital Management LP. Also participating were new backers Longaeva Partners LP and Brown Advisory, with continued support from existing investors, including Ally Bridge Group and Bain Capital Life Sciences. Read More
Atrogi AB is making a bid for a slice of the obesity market and has dosed the first overweight subjects with ATR-258, an oral therapy it says mimics the effects of exercise, driving loss of fat whilst sparing muscle. Read More
As AI continues to storm into global life, biopharma companies are figuring out ways to incorporate it into their operations, all with the goal of bringing better therapies to patients faster. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, numerous AI companies presented their offerings to attendees, driving interest and partnerships. Read More
Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. Read More
Neurodegenerative disease and cognitive decline cannot be explained by a single process. Beta-amyloid plaques, hyperphosphorylated tau, alpha-synuclein, activated microglia and astrocytes, altered receptors such as TREM2, mitochondrial dysfunction, epigenetic changes and cerebrovascular alterations all seem to contribute to the development of dementia in Alzheimer’s disease (AD). While scientists attempt to address each of these elements, prevention is growing as a primary goal. Read More
New hires and promotions in the biopharma and med-tech industries, including: Alchemab, Cerus, Field Medical, Galectin, GE, Idorsia, Neuronetics, Outrun, Transpire, Veracyte, VST. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Acumen, Aro, Ascendis, Ataibeckley, Candel, Cognition, Endogenex, Eupraxia, Greenwich, Heartflow, Mdxhealth, Neurosense, Pfizer, Priavoid, Rhythm. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Aldeyra, Biocardia, Fujirebio, Gyre, H.U. Group, Humacyte, Oxos, Perfuze, Polaryx, Polypid. Read More
