Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System

Shots: Elixir has reported European MDR CE Mark approval & commercial launch of LithiX Hertz Contact (HC) Intravascular Lithotripsy (IVL) System in EU to improve calcium & percutaneous coronary intervention treatment LithiX is a transcatheter device that uses low-profile metal hemispheres on a semi-compliant balloon to apply HC Stress, creating deep & wide fractures while…

ByRidhi RastogiApril 11, 2025

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Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Shots: Womed has entered into licensing agreements with Kebomed Europe & Saesco Medical to distribute Womed Leaf, an intrauterine adhesion barrier film, across Europe As per the agreement, Kebomed will handle distribution across France, Germany, Sweden, Denmark, Norway, Finland, Austria & Switzerland, while Saesco Medical will oversee commercialization in Spain, Italy, Portugal, Belgium, the Netherlands…

ByRidhi RastogiApril 9, 2025

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Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

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Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Shots: The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK's MAA will be filed via MHRA's IRP, with decision anticipated in the coming mos. MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials…

ByRidhi RastogiApril 2, 2025

News

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

Shots: The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway. Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…

ByDipanshu DixitApril 1, 2025

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BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots: The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

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The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…

ByRidhi RastogiMarch 27, 2025

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Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots: The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

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AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

ByRidhi RastogiMarch 17, 2025

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Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Shots: Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…

ByRidhi RastogiMarch 12, 2025

Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System

Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

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