Shionogi launches global Phase 2 trial for late-onset Pompe disease treatment

Esprit is a multicenter, randomized, placebo-controlled, double-blind study assessing the safety, pharmacodynamics, and preliminary efficacy of S-606001 as a substrate reduction therapy

Roche breaks lab barriers as FDA clears mass spec tests for wider use

The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio

Clariant boosts US pharmaceutical production with Clear Lake expansion

The Clear Lake facility marks Clariant’s first U.S. site dedicated to PEG excipient production

SK bioscience bags fresh backing to accelerate fight against respiratory disease

RSM01, a preventive treatment targeting respiratory syncytial virus (RSV), was licensed earlier this month from the Gates Medical Research Institute

Pfizer reports breakthrough in advanced prostate cancer with TALZENNA Plus XTANDI

The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI

Glenmark Therapeutics USA launches fluticasone propionate nasal spray

The Flonase Allergy Relief Nasal Spray, 50 mcg per spray market achieved annual sales of approximately $384.7 million

BioDuro and Cenra API Solutions forge global API manufacturing joint venture in Taiwan

The Taipei facility boasts 10 GMP API production lines, with a total reactor volume exceeding 350,000 liters

GenScript launches first European mRNA production hub in Delft, bolstering EU biotech leadership

QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system

The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals