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Alvotech & Advanz Pharma
NEWS

Alvotech Expands its Partnership with Advanz Pharma to Commercialize Three Additional Biosimilars in the EU

Shots: Alvotech has entered into an agreement with Advanz Pharma to expand their commercial partnership to include 3 more biosimilar candidates As per the deal, Advanz will register & commercialize biosimilars of Ilaris (canakinumab), Kesimpta (ofatumumab), & an undisclosed biologic in the EU, while Alvotech will handle development & commercial supply; partners will share revenues,…
May 29, 2025

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Rezolute
NEWS

Rezolute Reports Enrollment Completion in P-III (sunRIZE) Trial of Ersodetug for Congenital Hyperinsulinism

Shots: Rezolute has completed pts enrollment in P-III (sunRIZE/RZ358-301) trial of ersodetug as an add-on treatment of hypoglycemia in congenital hyperinsulinism pts, with 62 pts enrolled, exceeding the target of 56; the US FDA’s BLA filing is expected in 2026 Trial assessed ersodetug (5 or 10mg/kg, Q2W during initial loading then Q4W for 6mos.) + SoC vs…
May 29, 2025

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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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