Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
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.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Eli Lilly’s Cyramza appears to be on its way to picking up its sixth approval from the U.S. Food and Drug Administration as a treatment for some lung cancer patients following narrow support from an advisory committee.
Nexlizet is expected to be on the market in the U.S. in July 2020.
Kiadis Pharma N.V. announced the launch of a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia with off-the-shelf Natural Killer cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform.
A federal judge has ruled that a decade’s worth of unpublished clinical trial data from drug companies, universities and other agencies involved, must now be made public.
The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
The U.S. Centers for Disease Control and Prevention warned the public yesterday to be prepared for it to spread in the U.S., indicating it was “when,” not “if.”
The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which could speed up the process for potential approval.
Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
The company is planning for its drug for cholesterol lowering medications to hit the streets by the end of March. It will provide a new option to all the patients.