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Samsung Bioepis and Organon
NEWS

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
May 28, 2025

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AnX Robotica
NEWS

AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring

Shots: The US FDA has granted 510(k) clearance to MotiliCap & MotiliScan for GI motility monitoring MotiliCap is a radiation & sedation-free motility capsule that evaluates gastrointestinal transit across stomach, small bowel, & colon, with detailed GI data exported directly to MotiliScan for analysis MotiliScan is a companion software that offers intuitive visualization, data analysis,…
May 28, 2025

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GRIN Therapeutics & Angelini Pharma
NEWS

GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

Shots: GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global development As per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from…
May 28, 2025

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SiteOne Therapeutics
NEWS

Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

Shots: Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline  As per the deal, SiteOne shareholders will receive an upfront payment as well as regulatory & commercial milestones for a total consideration of ~$1B in cash     STC-004 is a non-opioid Nav1.8 inhibitor, which will advance into…
May 28, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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Astrazeneca
NEWS

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery   …
May 27, 2025

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Remegen
NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…
May 27, 2025

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GSK New
NEWS

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively    SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…
May 27, 2025

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