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NeurentMedical
News

Neurent Medical Receives the US FDA’s 510(k) Clearance of NEUROMARK System for Chronic Rhinitis

Shots: The US FDA has granted 510(k) clearance to the next generation NEUROMARK system for pts with chronic rhinitis The new system optimizes posterior nasal nerve treatment by providing real-time feedback for accurate electrode placement & confirming treatment delivery, with a flexible shaft & atraumatic leaflets that conform to pts anatomy for maximizing treatment coverage…
June 12, 20250Comments

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Johnson& Johnson
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Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Shots: The P-IIIb (APEX) trial assessed Tremfya (Q4W or Q8W) vs PBO for 24wks. in biologic-naïve PsA pts with inadequate response to SoCs, followed by a 24wk. active treatment period then a 12wk. safety follow-up; pts could enter a 2yr. extension phase prior to the final safety follow-up Trial showed reduced joint damage progression per…
June 12, 20250Comments

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Abbvie
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AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

Shots: The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis Label expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks. Trial…
June 12, 20250Comments

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MAGAZINE

PharmaShots Magazine-June-2025 Edition

Decentralized Clinical Trials (DCTs) colloquially known as hybrid trials were popularized during COVID-19. With the changing healthcare landscape, trial sponsors are looking for practices that are feasible and cost-effective. DCTs offer holistic solutions to mitigate the gaps in traditional clinical trial models by integrating emerging technologies and gadgets into the nuanced aspects of data capturing.…
June 12, 20250Comments

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News

Deep Apple Therapeutics Enters a Research Collaboration and Licensing Deal with Novo Nordisk to Advance Oral Small Molecules

Shots: Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…
June 12, 20250Comments

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News

Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B

Shots: Philochem and RayzeBio (BMS) entered into a development and commercialization agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize its radiopharmaceutical agent OncoACP3 for prostate cancer  Under the agreement, Philochem will receive $350M up front and is eligible for up to $1B in development, regulatory, and commercial milestones, plus…
June 11, 20250Comments

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News

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

Shots: The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026 Preclinical studies showed that NVC-001 significantly improved survival and cardiac function. They planned a P-I/II trial, a 52-week, open-label, multicenter ascending-dose study to assess the safety, tolerability, and…
June 11, 20250Comments

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News

OS Therapies & EVERSANA Partner to Commercialize OST-HER2 in the US for Pediatric Osteosarcoma

Shots: OS Therapies joined hands with EVERSANA to commercialize OST-HER2 in the US for the treatment of pediatric lung metastatic osteosarcoma This partnership leverages EVERSANA’s integrated commercialization platform, including market access, medical affairs, field deployment, patient services, and stakeholder engagement enabling OS Therapies to bring OST-HER2 to market rapidly and cost-effectively OS Therapies recently secured…
June 11, 20250Comments

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