Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots: Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…

ByRidhi RastogiJanuary 28, 2025

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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,…

ByRidhi RastogiJanuary 27, 2025

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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…

ByRidhi RastogiJanuary 27, 2025

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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%, &…

ByRidhi RastogiJanuary 27, 2025

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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…

ByRidhi RastogiJanuary 27, 2025

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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…

ByRidhi RastogiJanuary 27, 2025

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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…

ByRidhi RastogiJanuary 24, 2025

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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…

ByRidhi RastogiJanuary 24, 2025

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Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 for treating small cell lung cancer (SCLC) The designation is based on promising P-Ia/Ib trial data of ZL-1310 as monotherapy and with atezolizumab in treatment-experienced ES-SCLC patients, presented at the ENA Symposium 2024 ZL-1310 is a novel ADC targeting DLL3…

ByRidhi RastogiJanuary 23, 2025

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Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

Shots: Holon Health reported the development of Holon Vibe, a multi-modal therapeutic app to provide health evaluations & care plan management for people with SUD in Indiana & Arizona, with more states to be added in 2025 Primary data for the app showed a 65%+ appointment show rate for users, a 61-day increase in…

ByRidhi RastogiJanuary 23, 2025

Ridhi Rastogi

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

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

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

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

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