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Krystal Biotech
NEWS

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025 Opinion was based on various clinical data, incl. P-I/II (GEM-1)…
March 3, 2025

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Magnet Biomedicine & Eli Lilly
NEWS

Magnet Biomedicine Partners with Eli Lilly to Advance Molecular Glue Therapeutics in Oncology

Shots: Magnet Biomedicine & Eli Lilly have entered into a collaboration & license agreement to identify, develop & commercialize molecular glue therapeutics in oncology using Magnet's TrueGlue discovery platform As per the deal, Magnet will get ~$40M in upfront, near-term payments & equity, plus more than $1.25B in milestones across development, regulatory, & commercial…
March 3, 2025

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Fapon Biopharma
NEWS

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots: The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…
February 28, 2025

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Abbvie
NEWS

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25 Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper…
February 28, 2025

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BIOTRONIK
NEWS

Teleflex Enters a Definitive Agreement to Acquire BIOTRONIK’s Vascular Intervention Business for ~$797.7M (€760M)

Shots: Teleflex to acquire BIOTRONIK's vascular intervention business for ~$797.7M (€760M) in cash, subject to adjustments. Closing expecting in Q3’25 Acquisition will expand Teleflex’s interventional portfolio with coronary products like Pantera Lux Catheter, PK Papyrus Covered Stent & Orsiro Stent, plus peripheral product like Passeo-18 Lux Catheter, Dynetic-35 Stent, & Pulsar-18 T3 4F Stent,…
February 28, 2025

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Foresight Diagnostic & Allogene Therapeutics
NEWS

Foresight Diagnostic & Allogene Therapeutics Extend Collaboration to Develop Minimal Residual Disease (MRD) Assay

Shots: Foresight & Allogene have expanded their strategic collaboration to develop minimal residual disease (MRD) assay as companion diagnostic to identify candidates for Allogene's ALPHA3 trial assessing cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL) pts As per the collaboration, Allogene & Foresight will develop Foresight's MRD assay in the EU, UK, Canada &…
February 28, 2025

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New Drug Designations - January 2025
INSIGHTS+

New Drug Designations – January 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 January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…
February 28, 2025

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GRIN Therapeutic
NEWS

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Shots: The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk.…
February 27, 2025

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