Eli Lilly scored another win against diabetes Friday as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration.
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Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.
As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
Since the emergence of the COVID-19 pandemic, there has been increased interest in developing a universal antiviral that would stop a pandemic in its tracks.
Researchers at Yale University published research in Molecular Biology and Evolution describing a new molecular analysis approach to quantify DNA changes that contribute to cancer growth.
Elon Musk’s Neuralink was beaten to the clinic by a rival brain-computer interface company. Synchron enrolled the first patient in the COMMAND study that will assess the New York-based company’s implant in individuals with severe paralysis.
One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
North Korea’s admission that it is battling an “explosive” COVID-19 outbreak raised concerns that the virus could devastate a country with an under-resourced health system, limited testing capabilities, and no vaccine program.
At least one person confirmed to have COVID-19 has died in North Korea and hundreds of thousands have shown fever symptoms, state media said on May 13, offering hints at the potentially dire scale of the country’s first confirmed outbreak of the pandemic.