Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

Shots: The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts. Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…

ByRidhi RastogiFebruary 6, 2025

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The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots: The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…

ByRidhi RastogiFebruary 6, 2025

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Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC

Shots: Imagene & Tempus AI have collaborated to advance lung cancer diagnostics by enhancing biomarker prediction, integrating AI tools into clinical workflows, & allowing commercial access to diagnostic solutions Collaboration will integrate Imagene's AI multi-gene panel for rapid NSCLC biomarker prediction from biopsy images with Tempus' clinical reach & real-world data, creating a unified…

ByRidhi RastogiFebruary 6, 2025

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Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

Shots: Akeso has completed patient enrollment in the global P-III (HARMONi-6/AK112-306) trial (1/6 P-III trials) assessing ivonescimab + Pt-based CT vs Tevimbra + Pt-based CT to treat 1L squamous NSCLC in China Multiple P-III trials are underway, incl. HARMONi-3 (vs Keytruda + CT) in 1L sq- & non-sq NSCLC (led by Summit Therapeutics), plus trials…

ByRidhi RastogiFebruary 6, 2025

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Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Shots: Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD Data from both trials showed reduced…

ByRidhi RastogiFebruary 5, 2025

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Cumberland Pharmaceuticals Reveals Topline Data from P-II (FIGHT DMD) Trial of Ifetroban for Duchenne Muscular Dystrophy Heart Disease

Shots: Cumberland reported topline data from P-II (FIGHT DMD) trial assessing ifetroban (150/300mg, QD) vs PBO in DMD pts (n=41) for 12mos.; funded via the US FDA orphan products grant Study showed that ifetroban (300mg) led to 3.3% overall LVEF improvement (1EP), with a 1.8% increase vs 1.5% decline; on comparison with matched natural…

ByRidhi RastogiFebruary 5, 2025

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Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC

Shots: Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…

ByRidhi RastogiFebruary 5, 2025

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Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Shots: The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation System features 1min…

ByRidhi RastogiFebruary 5, 2025

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Aldevron Collaborates with TriLink BioTechnologies for CleanCap mRNA Capping Technology

Shots: TriLink & Aldevron have entered into a non-exclusive license & supply agreement for TriLink’s patented CleanCap mRNA capping tech, allowing Aldevron’s clients to use it for developing mRNA-based therapeutics & vaccines As per the agreement, TriLink will provide CleanCap M6, CleanCap AG 3’OMe, CleanCap AG, & CleanCap AU cap analogs to Aldevron for…

ByRidhi RastogiFebruary 5, 2025

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Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation Study demonstrated sustained vision…

ByRidhi RastogiFebruary 5, 2025

Ridhi Rastogi

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Cumberland Pharmaceuticals Reveals Topline Data from P-II (FIGHT DMD) Trial of Ifetroban for Duchenne Muscular Dystrophy Heart Disease

Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Aldevron Collaborates with TriLink BioTechnologies for CleanCap mRNA Capping Technology

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

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