Skip to content Skip to footer
Subscribe Now
VIEWPOINTS
Combating Hematologic Malignancies: Dr. Petri Bono from Faron Pharmaceuticals in Conversation with PharmaShots 
Shots:   Myelodysplastic Syndrome (MDS) is a rare and aggressive blood cancer in which the bone marrow fails to produce enough healthy blood cells  As resistance to traditional treatments continues to rise among MDS patients, Faron Pharmaceuticals' Bexmab emerges as a promising alternative  Dr. Petri Bono, Chief Medical Officer at Faron Pharmaceuticals, highlights Bexmab’s unique mechanism…
July 30, 20250Comments
NEWS
Madrigal Pharmaceuticals Signs a ~$2.1B Licensing Deal with CSPC Pharmaceutical for SYH2086
Shots: Madrigal has secured an exclusive global license from CSPC to develop, manufacture, & commercialize SYH2086 for advancing innovative combination therapies targeting MASH As per the deal, CSPC will receive $120M upfront & ~$2B in development, regulatory & commercial milestones, with net sales-based royalties; CSPC may also develop other oral GLP-1s in China under certain…
July 30, 20250Comments
NEWS
Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases
Shots: The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
July 30, 20250Comments
NEWS
Viridian Therapeutics Enters a ~$385M Deal with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan
Shots: Viridian & Kissei have entered into an exclusive collaboration & license agreement to develop & commercialize veligrotug & VRDN-003 in Japan As per the deal, Kissei will secure an exclusive license to develop & commercialize veligrotug & VRDN-003 in Japan, with the responsibility of all development, regulatory, & commercialization activities, & related costs in…
July 30, 20250Comments
Eli lilly
NEWS
Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL
Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…
July 30, 20250Comments
NEWS
IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)
Shots: The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond Approval was backed by P-III (IB1001-301) study assessing Aqneursa vs PBO in pts (≥4yrs.; n=60) with NPC, which showed improved neurological symptoms & function across all 1 & 2EPs within 12wks.,…
July 30, 20250Comments
Apellis
NEWS
Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN
Shots: The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.) Approval was based on P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli Trial met…
July 30, 20250Comments
INSIGHTS+
New Drug Designations: June 2025 
Shots:      PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…
July 29, 20250Comments