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Eli Lilly Partners & Creyon Bio
News
Eli Lilly Partners with Creyon Bio for Accelerated Discovery and Development of RNA-Targeted Oligonucleotides for Various Diseases
Shots:Eli Lilly has entered into a global licensing & multi-target research collaboration with Creyon Bio to identify, develop & market novel RNA-targeted oligonucleotide therapies for Lilly’s named targets using Creyon’s AI-powered Oligo Engineering EngineAs per the deal, Lilly will get exclusive rights of lead candidates & handle further research, development & marketing upon…
April 30, 20250Comments
Abeona Therapeutics
News
Abeona Therapeutics’ Zevaskyn Receives the US FDA Approval for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Shots:The US FDA has approved Zevaskyn (prademagene zamikeracel) for treating wounds in adult & pediatric RDEB pts based on the intra-pts controlled P-III (VIITAL) trial & has also granted RPD PRV to Abeona, which the company intends to monetize; Zevaskyn to be commercially available in Q3’25The P-III Trial assessed Zevaskyn in RDEB pts,…
April 30, 20250Comments
Insight+_Ridhi Rastogi
INSIGHTS+
New Drug Designations – March 2025 
Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA   The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…
April 29, 20250Comments
Personalis
News
Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)
Shots:Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRCAt 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…
April 29, 20250Comments
News
The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
Shots:The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC's decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyondStudy met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…
April 29, 20250Comments
Krystal Biotech
News
Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)
Shots:The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…
April 29, 20250Comments