Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

Shots: The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks. Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA…

ByRidhi RastogiJanuary 28, 2025

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ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…

ByRidhi RastogiJanuary 28, 2025

NEWS

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

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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

Ridhi Rastogi

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

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

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