NEWS

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots: China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, &…

January 27, 2025

Cstone Join Forces with SteinCares to Commercialize Sugemalimab in 10 Latin American Countries

Shots: CStone & SteinCares have partnered to commercialize sugemalimab, where SteinCares will gain its commercialization rights in 10 LATAM countries (incl. Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, & Ecuador), & CStone will handle its supply As per the terms, SteinCares will handle regulatory filings & marketing of sugemalimab in exchange for upfront, regulatory & commercial milestones as well as…

January 27, 2025

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

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…

January 27, 2025

IMMvention Therapeutix Partners with Novo Nordisk to Co-develop Oral BACH1 inhibitors for Chronic Conditions

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…

January 24, 2025

Virbac Launches Zenifel Pheromone Product to Address Stress-Related Behaviors in Cats

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…

January 24, 2025

Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally

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…

January 24, 2025

Lisata Therapeutics and WARPNINE Reports Initial Results from P-Ib/IIa (iLSTA) trial of Certepetide Regimen in Pancreatic Ductal Adenocarcinoma (PDAC)

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 &…

January 24, 2025

Rakuten Medical Commences Global P-III (ECLIPSE) Study of ASP-1929 Plus Keytruda as a 1L Treatment of Recurrent Head and Neck Cancer

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…

January 24, 2025

Abbvie Partners with Neomorph to Develop Novel Molecular Glue Degraders for Oncology and Immunology

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…

January 24, 2025

Tiziana Life Sciences Identifies New Immune Biomarkers in Multiple Sclerosis Patients Treated with Foralumab

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,…

January 23, 2025

NEWS

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Cstone Join Forces with SteinCares to Commercialize Sugemalimab in 10 Latin American Countries

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

IMMvention Therapeutix Partners with Novo Nordisk to Co-develop Oral BACH1 inhibitors for Chronic Conditions

Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally

Lisata Therapeutics and WARPNINE Reports Initial Results from P-Ib/IIa (iLSTA) trial of Certepetide Regimen in Pancreatic Ductal Adenocarcinoma (PDAC)

Rakuten Medical Commences Global P-III (ECLIPSE) Study of ASP-1929 Plus Keytruda as a 1L Treatment of Recurrent Head and Neck Cancer

Abbvie Partners with Neomorph to Develop Novel Molecular Glue Degraders for Oncology and Immunology

Tiziana Life Sciences Identifies New Immune Biomarkers in Multiple Sclerosis Patients Treated with Foralumab

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