FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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In a speech given at the Brookings Institution preceding the release of the U.S. Food and Drug Administration (FDA)’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb unloaded on big pharma.
In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs that received it.
HIV patients have some good news this morning. The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Symtuza, the first and only complete darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1).
Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.
Shares of Siga Technologies soared more than 11 percent late Friday after the company announced that its smallpox treatment Tpoxx was approved by the U.S. Food and Drug Administration.
July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month there are only four more approvals on the docket, here are the remaining approvals scheduled for July.
The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.
On May 29, the FDA cleared T2 Biosystems’ T2Bacteria Panel for diagnosis of sepsis. In that sepsis is the third-leading cause of death in the U.S., this emphasizes the importance of work in this area.