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NEWS

SetPoint Medical Receives the US FDA’s Approval for its SetPoint System to Treat Rheumatoid Arthritis

Shots: The US FDA has approved the SetPoint System to treat adults with mod. to sev. rheumatoid arthritis (RA) who are inadequately managed by or intolerant to existing advanced therapies, incl. biologics & targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) Approval was based on RESET-RA study evaluating SetPoint System vs sham device in 242 pts, which…
July 31, 2025

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Abbvie
NEWS

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

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NEWS

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

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NEWS

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

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NEWS

Madrigal Pharmaceuticals Signs a ~$2.1B Licensing Deal with CSPC Pharmaceutical for SYH2086

Shots: Madrigal has secured an exclusive global license from CSPC to develop, manufacture, & commercialize SYH2086 for advancing innovative combination therapies targeting MASH As per the deal, CSPC will receive $120M upfront & ~$2B in development, regulatory & commercial milestones, with net sales-based royalties; CSPC may also develop other oral GLP-1s in China under certain…
July 30, 2025

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NEWS

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

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NEWS

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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Eli lilly
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Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…
July 30, 2025

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