A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Source: Drug Industry Daily
BridgeBio’s investigational cardiomyopathy molecule acoramidis (AG10) fell short of the phase 3 finish line this week, when it not only failed its primary endpoint, but was associated with decreases in…
Two doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Ad26.COV2.S) cut the risk of a COVID-related hospitalization by 85 percent, the company has reported — and the benefit may…
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy…
Amylyx Pharmaceuticals has scored a priority review by the FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for amyotrophic lateral sclerosis (ALS). Source: Drug Industry Daily
With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval marks the Denmark-based company’s…
People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South…
In terms of approvals of new products, 2021 was the second-best year for cell and gene therapies and tissue products (The best year was 2016, when nine therapies were approved.).…
FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints. Source:…
The FDA has approved Novartis’s new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago because of manufacturing concerns. Source: Drug Industry Daily