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The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More
In another hurdle for BioMarin Pharmaceutical’s investigational hemophilia A gene therapy valoctocogene roxaparvovec, the European Medicines Agency (EMA) has now asked the company to provide a full one-year follow up data from its ongoing phase 3 trial. Read More
The FDA has approved GlaxoSmithKline’s (GSK) and Innoviva’s Trelegy Ellipta (fluticasone furoate /umeclidinium /vilanterol) as a maintenance treatment for asthma in patients ages 18 years and older whose asthma is uncontrolled with inhaled corticosteroids and long-acting beta agonist therapy. Read More
As the race for COVID-19 vaccines intensifies, the unprecedented problems of distributing them once they get regulatory approval are coming into focus — including the need for refrigeration throughout the supply chain. Read More
Novartis and Roche have been hit with a combined $526 million in fines by France’s competition regulator for using “abusive practices” to boost sales for an expensive age-related macular degeneration (AMD) drug by discouraging a much cheaper alternative. Read More
FDA Commissioner Stephen Hahn made clear on Thursday that he will not intervene in any decisions made by career staff on COVID-19 vaccine approvals, even though he has the authority to overrule them. Read More
The National Institutes of Health (NIH) launched two phase 3 trials yesterday, evaluating different types of blood thinners to treat COVID-19 patients. Read More
As long as a safety review of an AstraZeneca COVID-19 trial that’s been paused due to an illness allows the trial to resume, the drugmaker expects to stay on track and submit its vaccine candidate for regulatory approval by the end of the year. Read More