While AZ resumes its COVID-19 vaccine trial in ...

Moderna's COVID-19 vaccine triggers an immune response in older adults Moderna showed robust phase 1 results for its COVID-19 vaccine in adults up to 55 last month. It is now following up with data from a small group of older adults, and they look positive. The phase 1 study that is being run by the National ...

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial  Novartis recently declared the results of its Phase III COMBI-I trial evaluating its experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) for patients, previous...

FDA rejects BioMarin's gene therapy and Gilead's filgotinib over concerns The FDA refused to approve BioMarin's hemophilia A gene therapy valoctocogene roxaparvovec. The U.S. regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) lett...

Researchers call out Gilead over the diversity of remdesivir trials Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Bla...

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy  The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in muscle atrophy, in adults and...

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. The Indian company informed that the DNA vaccine was well tolerated in the first stage of t...