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NEWS
Solid Biosciences & Kinea Bio Partner to Advance KNA-155 Using AAV-SLB101 for Dysferlin-Related Limb-Girdle Muscular Dystrophy
Shots: Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsid As per the deal, Kinea Bio will receive a non-exclusive global license to utilize AAV-SLB101 for the delivery of KNA-155, which will enter IND-enabling studies…
7 hours ago0Comments
NEWS
Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases
Shots: The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…
8 hours ago0Comments
Astrazeneca & Daiichi Sankyo
NEWS
Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer
Shots: The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026) sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…
9 hours ago0Comments
BMS
NEWS
BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat R/R Multiple Myeloma
Shots: BMS has reported the P-III (EXCALIBER-RRMM) trial data assessing iberdomide + daratumumab + dexamethasone (IberDd) vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma The trial has 2 stages: Stage 1 randomized ~200 pts to iberdomide (1, 1.3, or 1.6mg) plus daratumumab & dexamethasone, identifying 1mg as the selected dose; Stage…
11 hours ago0Comments
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…
12 hours ago0Comments
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…
1 day ago0Comments
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,…
1 day ago0Comments
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…
1 day ago0Comments