Regulatory
The new designation could speed up the time for approval and could also provide a period of market exclusivity for generics of branded medicines that have no competition.
Two of the three drugs that were up for review in mid- to late-February received much earlier approval in December 21, the day before the federal government shutdown. The shutdown ended on January 25, 2019.
Following international concern and outrage over a gene editing treatment of human embryos in China, the World Health Organization is taking action.
If the new funding bill is signed by the president, the FDA will have some extra funds to support various initiatives.
Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera.
DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of Peanut-Allergic Children 4 to 11 Years of Age
Eisai Co., Ltd. announced that it has submitted an application to the European Medicines Agency for its in-house discovered antiepileptic drug Fycompa seeking approval for use in pediatric patients with epilepsy.
History shows just how slow public health officials, the federal government, regulators and pharmaceutical companies were to respond to the emergence of HIV in the 1980s. The reasons are numerous—it was a puzzling viral disease, it first appeared in what was then a largely stigmatized patient population, gay men, and there weren’t really any existing treatments for viral diseases.
After the U.S. Food and Drug Administration (FDA) took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
Lawmakers continue to hear concerns over drug prices, as well as proposals to fix the issue.
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