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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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Belite Bio
NEWS

Belite Bio Reveals Interim P-III (DRAGON) Trial Data of Tinlarebant for Adolescent Stargardt Disease

Shots: Belite Bio has reported 1yr. interim data from P-III (DRAGON) trial assessing tinlarebant vs PBO in adolescent stargardt disease pts (n=104). Completion expected in Q4’25 with DSMB recommending data submission for regulatory review The global Phase III trial utilized an adaptive sample size re-estimation design to evaluate atrophic lesion growth rate, safety & tolerability…
February 27, 2025

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