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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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Novo-Nordisk
NEWS

Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease

Shots: Novo Nordisk reported that etavopivat met both co-1EPs in the P-III (HIBISCUS) study, reducing vaso-occlusive crises (VOCs) and improving haemoglobin response in sickle cell disease The study (n=385, ≥12yrs) evaluated Etavopivat (400mg) vs PBO demonstarting reduced VOCs rates by 27% and delayed time to first VOC (~38.4 vs 20.9 weeks), while 48.7% of patients…
April 20, 2026

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Gedeon Richter
NEWS

Gedeon Richter Reports the EC Approval of Fylrevy for Hormone Replacement Therapy (HRT) 

Shots:  The EC has approved Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg) across EEA markets  Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women  Preclinical and clinical data show that estetrol (E4) has…
March 27, 2026

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Amgen
NEWS

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
March 26, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

Merz Therapeutics Enrolls First Patients in P-III Studies Evaluating Xeomin for Migraine Prevention

Shots: Merz Therapeutics has enrolled the first patients in two global P-III studies, MINT-E (episodic migraine, ~990 pts) and MINT-C (chronic migraine, ~780 pts), evaluating the efficacy and safety of Xeomin (incobotulinumtoxinA) for migraine prevention Both studies will recruit ~1,770 adults across 120 sites in North America & Europe, and recruitment in Europe is expected…
August 26, 2025

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VIEWPOINTS_Volker Wacheck_2024
VIEWPOINTS

Volker Wacheck Discusses the Approval of the Lonsurf Combination Drug for the Treatment of Colorectal Cancer

Shots:  Volker Wacheck sheds light on the recent approval of Lonsurf in combination with bevacizumab for patients with metastatic colorectal cancer  While sharing key insights from the pivotal P-III (SUNLIGHT) trial evaluating Lonsurf ± bevacizumab, Volker reveals that the combination drug is proven to prolong both OS and PFS along with QoL benefits and a…
January 2, 2024

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VIEWPOINTS_Liz Hurlburt_2023
VIEWPOINTS

Liz Hurlburt sheds light on DefenCath, a one of the kind, catheter lock solution

Shots:  Liz Hurlburt, Executive Vice President of Clinical & Medical Affairs at CorMedix discusses the revolutionary prospects of DefenCath, a catheter lock solution to prevent CRBSIs in patients receiving hemodialysis via. CVC   Liz sheds light on a serious unmet need for patients affected with catheter-related bloodstream infections. CRBSIs affect approximately 250,000 people annually who receive…
October 31, 2023

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