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Abbvie
AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia
Shots: The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL) sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing Venclexta + acalabrutinib ± Obinutuzumab vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation Trial showed that Venclexta + acalabrutinib a 35% reduction…
July 31, 2025
Purpose Pharma’s Attrogy Secures the EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis   
Shots:  The EC has approved Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or 2 polyneuropathy in all EEA states   EC approval was based on a P-III trial showing that diflunisal significantly slowed disease progression in patients with TTR amyloidosis. At 24 mos. baseline, 1EP met diflunisal led to…
July 31, 2025
PBI-Gordon Companies Reports US Availability of Felycin-CA1 to Treat Feline Hypertrophic Cardiomyopathy
Shots: PBI-Gordon Companies has reported US availability of Felycin-CA1 (sirolimus delayed-release tablets) via licensed veterinarians Felycin-CA1 has been conditionally approved by the US FDA for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM) based on RAPACAT study The company is seeking a full new animal drug approval of Felycin-CA1 for cats with HCM through the…
July 31, 2025
Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment
Shots: The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function  Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…
July 31, 2025
Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases
Shots: The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
July 30, 2025
Viridian Therapeutics Enters a ~$385M Deal with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan
Shots: Viridian & Kissei have entered into an exclusive collaboration & license agreement to develop & commercialize veligrotug & VRDN-003 in Japan As per the deal, Kissei will secure an exclusive license to develop & commercialize veligrotug & VRDN-003 in Japan, with the responsibility of all development, regulatory, & commercialization activities, & related costs in…
July 30, 2025
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