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NEWS
Variational AI Collaborates with Merck to Develop Small Molecule Therapeutics
Shots: Variational AI has entered into a collaboration with Merck to design and optimize novel small molecule candidates against two undisclosed targets using Variational AI’s Enki platform As per the deal, Variational AI will leverage its fine-tuned Enki platform trained on Merck’s proprietary data to generate & optimize small-molecule candidates for Merck’s targets, with Merck…
September 24, 20250Comments
NEWS
AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP
Shots: The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…
September 24, 20250Comments
INSIGHTS+
New Drug Designations – August 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 August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
September 23, 20250Comments
NEWS
Angelini Pharma Enters an Exclusive Option Agreement with Sovargen to Develop and Commercialize SVG105 for Brain Disorders
Shots: Angelini Pharma has entered into an exclusive global option agreement with Sovargen to develop & commercialize SVG105 for the treatment of brain health disorders As per the deal, Angelini & Sovargen will co-lead preclinical development of SVG105, with Angelini having the option to advance it clinically & commercially outside Korea, China, Hong Kong, Macau,…
September 23, 20250Comments
NEWS
Starpharma Inks a ~$569.5M Deal with Genentech to Develop Cancer Therapies
Shots: Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech As per the deal, Genentech will receive an exclusive global license under Starpharma’s IP to develop & commercialize collaboration-derived products, potentially multiple per target, in exchange for…
September 23, 20250Comments
Ionis
NEWS
Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome
Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…
September 23, 20250Comments