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Although the FDA has been especially vigilant towards websites selling sham COVID-19 products during the pandemic, it’s still keeping an eye out for unlawful opioid vendors, and it issued multiple warning letters last week to online firms that illegally sold opioid products. Read More
Roche has unveiled new data for its multiple sclerosis drug Ocrevus (ocrelizumab) that further supports its ability to hinder disease progression. The positive new findings come shortly after the FDA’s recent approval of Novartis’ Kesimpta (ofatumumab), a drug that could prove to be a formidable rival to Roche’s blockbuster product. Read More
AstraZeneca announced on Saturday that it has resumed its phase 3 COVID-19 vaccine trial in the UK after pausing it last Tuesday due to a single “unexplained illness.” Read More
Refocusing new drug R&D to a more patient-centric approach, an using new technology alongside soft skills like empathy and collaboration, are among the changes the pharmaceutical industry can expect in coming years. Read More
The abuse-deterrent formulation of Purdue Pharma’s OxyContin (oxycodone Hcl) does have some benefit in reducing abuse of the opioid medication, a joint meeting of two FDA advisory committees decided in three separate votes on Friday. Read More
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