The U.S. Food and Drug Administration issued final guidance on May 17 on master protocols for evaluating prevention and treatment options for Covid-19. The guidance took effect immediately and will remain in effect throughout the pandemic.
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Since the 1800s, scientists have pushed governments to overhaul water supply systems for cleaner, safer water to stop the outbreak of waterborne pathogens. Now, researchers are calling for a similar “paradigm shift” in indoor ventilation systems to combat Covid-19 and other airborne pathogens.
The U.S. Food and Drug Administration approved Apellis Pharmaceuticals’ Empaveli as the first targeted C3 therapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
Sanofi and GlaxoSmithKline reported positive data on their Covid-19 vaccine candidate in all adult age groups in a Phase II trial of 722 volunteers. The companies expect to launch a global pivotal Phase III trial in the coming week.
The U.S. Supreme Court on May 17 dashed Novartis AG’s hopes of launching a generic version of Amgen Inc.’s multibillion-dollar rheumatoid arthritis medicine Enbrel, declining to hear the company’s challenge to two patents on the drug.
The U.S. Supreme Court rejected a bid by Johnson & Johnson to overturn a $70 million jury verdict against the pharmaceutical company for J&J’s failure to warn about risks associated with off-label uses of the antipsychotic drug Risperdal.
The Children’s Eye Foundation of AAPOS unveiled the world’s first interactive children’s book to help screen for color vision deficiency (CVD), commonly known as color blindness. The foundation posted a free digital version of THE CURIOUS EYE at thecuriouseye.org and published a first-run, hardcover book for its member pediatric ophthalmologists.
Incyte Corp. said on May 17 the company’s ruxolitinib cream to treat pigmentation disorder vitiligo met the main goal in a late-stage study.
The Janssen Pharmaceutical Companies of Johnson & Johnson presented data from the Phase 3 VOYAGER PAD study which showed Xarelto (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization compared to aspirin alone regardless of whether it was the first, second, third or subsequent event.
Regeneron Pharmaceuticals said on May 17 the company was resuming the enrollment of patients in two studies testing the experimental lymphoma drug odronextamab after the U.S. Food and Drug Administration agreed to lift a partial clinical hold.