Government
Despite the data concerns, the U.S. Food and Drug Administration said it believes the gene therapy should remain on the market. Novartis said it stands behind the safety and efficacy of the therapy.
Supporting rare disease diagnosis, education, and clinical research
Singapore scientists and clinicians have discovered a promising use of antibodies to target a new cancer antigen, as an alternative for chemotherapy
A new high-resolution approach using portable DNA sequencers provides a more complete genomic picture of antibiotic resistance in gut bacteria
As reported yesterday, the Trump administration is evaluating proposals to allow consumers to buy drugs legally from Canada. Today, their efforts became more official as the U.S. Department of Health and Human Services announced their intentions.
On July 18, it was reported by Reuters that Canada is opposed to any U.S. plans to buy Canadian prescription drugs because the country fears it will threaten its own drug supply or raise costs for its own people.
Specifically, the civil subpoenas were issued to determine if the company had violated antitrust laws with its rheumatoid arthritis drug Remicade.
A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.
It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.
As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry.
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