The Food and Drug Administration (FDA) had granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.
Genomic data can have a significant effect on other areas of society. Insurance premiums, familial impact, identification. As we enter the genomic era, policy will need to reflect these new considerations.
FDA Commissioner Scott Gottlieb said he will do everything “within my lane” to combat high drug prices and that he sees drug companies “gaming the system to try to block competition” in a multitude of ways in the marketplace.
At a biohacking conference this week, a biotech CEO dropped his pants and injected himself in the thigh with an experimental herpes treatment created by his company, leaving other biohackers worried.
Drugmaker company, Roche has been granted FDA approval for its breakthrough therapy designation for Balovaptan to treat Autism Spectrum Disorder (ASD), potentially accelerating its development and approval.
This is the first U.S. approval for this kind of treatment, known as peptide receptor radionuclide therapy.
A KHN data analysis finds the door of opportunities connecting Capitol Hill, the federal government, and the drug industry likely spins in Big Pharma’s favour. Exhibit A: Alex Azar.
Former drug industry executive, Alex Azar was confirmed by a Senate vote on Wednesday as the next secretary of the Department of Health and Human Services.
Southern Illinois University’s medical school has halted all herpes research, one of its most high-profile projects, amid growing controversy over a researcher’s unauthorized methods offshore and in the U.S.
U.S. researchers are relieved to hear that their government shutdown is finally over. Congress approved legislation on 22 January to fund government operations until 8 February, with U.S. President Donald Trump signing soon after.
Over the weekend, the U.S. saw its government partially shutdown, after the U.S. Senate failed to advance funding legislation. A large number of science groups are now left figuring out if they can keep working.
For some federal health programs, a shuttered government means business as usual. But the congressional impasse over funding will hit others hard.
The European Patent Office (EPO) has revoked a patent granted to the Broad Institute for fundamental aspects of the technology, in the latest installment of the CRISPR patent battle.
For those of you who haven’t experienced the process to secure Food and Drug Administration approval, it can be quite the minefield. Helping to solve those woes is new company Enzyme.com.