NEWS

Novo Nordisk Completes P-Ib/IIa Study of Subcutaneous Amycretin in Overweight or Obese People

Shots: The P-Ib/IIa trial assessed amycretin (Q1W) vs PBO in overweight or obese patients (n=125) in 5 parts Part A (single ascending dose) assessed PK & determined the initial dose for Part B (multiple dose arm), which evaluated safety/tolerability over 36wks. Parts C, D, & E (PoC) evaluated weight loss with 3 doses (1.25mg,…

January 27, 2025

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Shots: P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer P2 pts (n=880) received Keytruda (400mg, IV…

January 27, 2025

Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1

Shots: The US FDA has granted FTD to DYNE-101 for treating myotonic dystrophy type 1 (DM1). US Accelerated Approval is anticipated to submit in H1’26 DYNE-101 is being tested in the global P-I/II ACHIEVE trial for DM1 DYNE-101 is an antisense oligonucleotide (ASO) linked to an antibody fragment (Fab) that targets the transferrin…

January 27, 2025

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

NEWS

Novo Nordisk Completes P-Ib/IIa Study of Subcutaneous Amycretin in Overweight or Obese People

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1

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)

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