DUBLIN – Glaxosmithkline plc and Anaptysbio Inc. were able to get over some of the disappointment arising from a delayed FDA decision on their PD-1 inhibitor, dostarlimab, earlier this month, as the EMA came through Feb. 26 with a positive recommendation for the drug in endometrial cancers that are deficient in DNA mismatch repair or that are categorized as having high microsatellite instability.
In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
In its first decision on excessive drug pricing, the European Commission (EC) accepted a commitment Feb. 10 from Aspen Pharmacare Holdings Ltd. to immediately drop the price of six essential cancer drugs in Europe by an average of 73% and to continue to supply the drugs for at least the next five years.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.