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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
In prepared remarks at a Senate hearing today, National Institutes of Health Director Francis Collins is expected to say that there is “growing optimism” that one of the multiple COVID-19 vaccine candidates will prove safe and effective by late 2020 or early 2021. Read More
China’s National Medical Products Administration has approved Innovent Biologics’ Humira biosimilar Sulinno (adalimumab injection) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis. Read More