Switzerland-based Roche is in talks with the U.S. Food and Drug Administration over the company’s Alzheimer’s drug candidate gantenerumab, which is being evaluated in clinical studies with a large-scale Phase III trial expected to wrap in the second half of 2022.
The World Health Organization recommended using arthritis drugs Actemra from Roche and Kevzara from Sanofi with corticosteroids for Covid-19 patients after data from some 11,000 patients showed they cut the risk of death.
Novartis AG wants Roche Holding AG to return $210 million after accusing the company’s Swiss rival of inappropriately pocketing fees from a 16-year-old patent licensing agreement, according to a lawsuit in U.S. District Court.
The European Commission approved Roche’s injectible drug Enspryng, which can be administered at home to treat neuromyelitis optica spectrum disorder.
U.S. health regulators approved Roche’s arthritis drug Actemra for emergency use to treat hospitalized Covid-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
Roche presented results from several Phase II and III trials at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting held virtually June 19-22.
Pfizer Inc., Merck & Co. Inc., Roche Holding AG, and other companies are racing to produce the first antiviral pill that people could take at early signs of Covid-19. Their shared goal: filling a key treatment hole by helping people recently infected with the novel coronavirus to avoid becoming seriously ill and needing hospitalization.
An immunotherapy showed for the first time it can help early-stage lung cancer patients survive longer without their disease returning, according to data on May 19, a potential turning point for such drugs to be used before tumors spread.
Roche’s cobas SARS-CoV-2 Test received U.S. authorization for testing individuals without symptoms or reasons to suspect a Covid-19 infection, the Swiss drugmaker said on May 18.
India gave emergency use authorization for a Covid-19 antibody drug cocktail developed by Roche and Regeneron, expanding the company’s arsenal of drugs to battle a massive second wave of infections. The decision was taken based on data filed with the U.S. regulators and the scientific opinion of a European regulatory panel, Roche’s India distribution partner for the drug, Cipla, said on May 5.