Shots:FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry
Study showed that it localized disease in ~80% patients & detected double the…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below: Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes Read More: Novo Nordisk Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…
Shots:IMMvention & Novo Nordisk have entered into a strategic collaboration & license agreement to jointly develop oral BACH1 inhibitors for SCD & other chronic conditions
As per the terms, Novo Nordisk will get an exclusive worldwide license of the systemic BACH1 program, while IMMvention retains rights to develop brain-penetrant BACH1 inhibitors, targeting diseases…
Shots:Virbac has launched Zenifel pheromone product in two formats (gel diffuser & Spray) to manage stress-related behaviors in cats & improve their health
Zenifel Gel Diffuser provides ~2mos. of calming effects, covering ~750 sq. ft. & reducing stress by ~80%, while the spray format offers 400+ odorless sprays, plus ensures quick relief for…
Shots:Medidata and Tigermed have expanded their 13yrs. collaboration to leverage the former’s Medidata Platform across all trial phases, enhancing workflows, regulatory compliance & delivery of therapies globally
Tigermed will integrate the platform with their workflow, automate data capture, streamline operations to enhance trial efficiency for accelerating time to commercialize new therapies
The…
Shots:P-Ib/IIa (iLSTA) trial assessed certepetide (LSTA1; iRGD cyclic peptide) ± SoC CT ± Imfinzi in LA inoperable PDAC pts (N=30) randomized into 3 arms, with A1 (n=5) receiving SoC CT + PBO Imfinzi & PBO certepetide; A2 (n=5) receiving SoC CT + certepetide & PBO Imfinzi; A3 (n=20) receiving SoC CT + Imfinzi &…
Shots:The company has begun P-III (ECLIPSE) trial of ASP-1929 (photoimmunotherapy) + Keytruda for HNSCC, with first patient treated at a site across the US. Recruitment is underway in Japan, Taiwan & other regions
This global study aims at assessing safety & efficacy of ASP-1929 + Keytruda vs Keytruda-based SoC as a 1L treatment…
Shots:AbbVie & Neomorph have partnered in a collaboration & option-to-license deal to develop molecular glue degraders for oncology & immunology, using Neomorph's molecular glue discovery
As per the terms, Neomorph will receive upfront & is eligible for ~$1.64B in future option fee & milestones, plus net sales-based royalties
Molecular glue degraders are…
Shots:Tiziana identified new immune biomarkers in na-SPMS patients treated with nasal foralumab, using single-cell RNA sequencing of peripheral blood samples taken before treatment & at 3 as well as 6mos. post-administration
Study showed that after dosing in ongoing ISPPEA (expanded access program; n=10), gene expression changed starting 3mos. incl. modulation of FoxP3 Tregs,…
Shots:P-II neoadj. studies were UNICORN (n=56) & NEST (n=24) in resectable CRC. UNICORN: 93% & 29% pCR with 100% & 36% pMR in dMMR/MSI-H & pMMR/MSS tumors, respectively; NEST: At 18 (NEST-1) & 9mos. (NEST-2) follow-up, all were ctDNA-ve w/o recurrences; pMR improved to 47% in MSS tumors in NEST-2
P-I/II study of BOT/BAL…
