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Roche
Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection
Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…
August 7, 2025
Marea Therapeutics
Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease
Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…
August 7, 2025
Vertex Pharmaceuticals
Vertex Reports the P-II Study of VX‑993 in Acute Pain After Bunionectomy
Shots: Vertex announced topline results from its P‑II study of selective NaV1.8 inhibitor VX‑993 in 367 pts with acute pain post-bunionectomy; VX‑993 did not achieve a statistically significant improvement in SPID48 vs placebo VX‑993 was safe and well tolerated at all doses, with AEs mostly mild/moderate; no SAEs related to VX‑993 and no discontinuations due…
August 7, 2025
Jazz Pharmaceuticals Reports the US FDA’s Approval of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma 
Shots:  The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial  Approval was based on data from 50 pts across 5 studies, showing…
August 6, 2025
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