The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a phase I trial, while potential fast-followers from Nurix Therapeutics Inc. and Recludix Pharma Inc. advanced via respective partnerships with Sanofi SA.
After reporting in April that its gastrointestinal reprogramming product (Garp) failed to meet the primary efficacy endpoint in a phase II trial in irritable bowel syndrome (IBS), Anatara Lifesciences Ltd. conducted a further analysis that shows a positive trend toward efficacy.
New dose-escalation data from Verastem Oncology’s phase I/II cancer study in China prompted the company to say it was encouraged by the efficacy results. However, investors felt otherwise, as the stock lost about 20% of its value the day the initial results were released.
Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases.
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
After reporting in April that its gastrointestinal reprogramming product (Garp) failed to meet the primary efficacy endpoint in a phase II trial in irritable bowel syndrome (IBS), Anatara Lifesciences Ltd. conducted a further analysis that shows a positive trend toward efficacy.
Four months after Vertex Pharmaceuticals Inc.’s U.S. FDA nod for Journavx (suzetrigine) as the first drug targeting NaV1.8 for treating pain, Eli Lilly and Co. is joining the potential competition via a buyout of Siteone Therapeutics Inc., a privately held firm developing small-molecule sodium channel inhibitors, including a phase II-ready NaV1.8 inhibitor.
GSK plc knew a good thing when it swooped in nearly three years ago to rescue Spero Therapeutics Inc.’s oral antibiotic from a complete response letter (CRL). New pivotal phase III study data showed tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infections (cUTI), including pyelonephritis, hit its primary endpoint.
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