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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 Engine As per the deal, Lilly will get exclusive rights of lead candidates & handle further research, development & marketing upon…
April 30, 20250Comments

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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 Q3’25 The P-III Trial assessed Zevaskyn in RDEB pts,…
April 30, 20250Comments

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Insight+_Dipanshu Dixit
INSIGHTS+

Disease of the Month – Myocardial infarction (MI)

Shots:  Myocardial infarction (MI), colloquially known as a heart attack, occurs when blood flow to the heart is severely reduced or blocked, causing tissue damage or mortality due to lack of oxygen  PharmaShots' Disease of the Month report aims to familiarize the general population with conditions impacting communities worldwide. The report outlines disease characteristics, types,…
April 30, 20250Comments

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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

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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 CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…
April 29, 20250Comments

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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 & beyond Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…
April 29, 20250Comments

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Realmada Therapeutics
News

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Shots: Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…
April 29, 20250Comments

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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 H2'25 Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…
April 29, 20250Comments

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