AstraZeneca had a very busy week of international news, with progress being shown in China, positive recommendations for two drugs in Europe, and a positive clinical trial update.
Tag Archive for: clinical trials
Shares of Angion Biomedica Corp. are falling fast after the company announced it had discontinued a mid-stage study of an oral tyrone kinase inhibitor in patients with primary proteinuric kidney diseases due to safety reasons. And Novo Nordisk also hit a wall, reporting that its diabetes drug Ozempic (semaglutide) failed to inprove liver fibrosis in NASH-related cirrhosis.
Initial results from Jazz Pharmaceuticals’ Phase III study on Sativex (JZP378) for the treatment of multiple sclerosis failed to achieve the primary endpoint of an improvement in muscle tone.
Germany’s BioNTech, Pfizer’s partner in COVID-19 vaccines, said the two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year.
Adopting digital transformation is now an industry standard for success – but what precisely does that mean for the clinical development landscape? Gary Shorter, Head of Artificial Intelligence at IQVIA, explores the answers.
The U.S. Food and Drug Administration has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event (SAE).
Sarepta Therapeutics announced Thursday that the U.S. Food and Drug Administration has put the Phase II trial of its Duchenne muscular dystrophy (DMD) candidate SRP-5051 (vesleteplirsen) on clinical hold following a serious safety signal.
For years, PTC Therapeutics has attempted to win regulatory approval for its Duchenne Muscular Dystrophy drug, Translarna (ataluren), but time and time again, the U.S. Food and Drug Administration has rejected the attempts. Now, the company believes it has data that will support another filing for possible approval.
North Carolina-based 9 Meters Biopharma, a clinical-stage company that creates treatments for digestive diseases, is discontinuing its Phase III trial studying larazotide for the treatment of celiac disease due to disappointing interim results.
June is Myasthenia Gravis Awareness month. As with so many rare diseases, the standard of care for myasthenia gravis (MG) doesn’t address the root of the illness and comes with side effects that can be serious. Nipocalimab, which is in Phase III development at Janssen, goes to the cause of the disease.
