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Astrazeneca
AstraZeneca Reports the Data from PURSUIT P-IIb Study Evaluating AZD0780
Shots: AstraZeneca presented data at the ACC'25 and simultaneously published data in JACC from the PURSUIT P-IIb study (n=480) evaluating the efficacy, safety, and tolerability of AZD0780 (1mg, 3mg, 10mg & 30mg QD) added to SoC statin therapy vs PBO in dyslipidemic patients with LDL-C levels ≥70 and <190 mg/dL on moderate or high intensity…
April 1, 2025
Visby Medical
Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use
Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…
March 31, 2025
Spirited Paw
Spirited Paw Launches Calm Chewable Wafers for Dogs and Cats
Shots: Spirited Paw (Standard Process' Brand) has launched Calm supplement to manage stress-related behaviors like occasional anxiety in cats & dogs Calm consists of scientifically-backed ingredients along with plant-based nutrients like Kalette, ginger & chamomile extracts, grown on Standard Process’ 868-acre USDA-certified organic farm   Calm contains L-Theanine, L-Tryptophan, & marine-derived Magnesium, with L-Theanine tested in…
March 31, 2025
Astrazeneca
AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL)
Shots: The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regions Opinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…
March 31, 2025
Sanofi & Regeneron
Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)
Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
March 28, 2025
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