Shots:Biogen has collaborated with City Therapeutics to develop novel RNAi therapies, leveraging the former’s drug delivery tech & City’s RNAi engineering techAs per the deal, City will receive $46M incl. $16M upfront + $30M investment in exchange for its convertible note, also eligible to receive ~$1B as development & commercial milestones, with high…
Shots:FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vialDesignation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
Shots:The US FDA has granted 510(k) clearance to MotiliCap & MotiliScan for GI motility monitoringMotiliCap is a radiation & sedation-free motility capsule that evaluates gastrointestinal transit across stomach, small bowel, & colon, with detailed GI data exported directly to MotiliScan for analysisMotiliScan is a companion software that offers intuitive visualization, data analysis,…
Shots:GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global developmentAs per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from…
Shots:Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline As per the deal, SiteOne shareholders will receive an upfront payment as well as regulatory & commercial milestones for a total consideration of ~$1B in cash STC-004 is a non-opioid Nav1.8 inhibitor, which will advance into…
Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
Shots:The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regionsOpinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …
