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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The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion is interested in how social media affects the public’s perception of drugs.
The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
Now that global responses are fully mobilized, what is being done to identify and develop drugs and vaccines against this novel coronavirus?
Eisai indicated it was voluntarily withdrawing the drug, but in a statement noted it disagreed with the FDA’s interpretation of the data and believes the drug’s benefits outweigh the cancer risk.
Did the price of a newly-approved treatment for a rare autoimmune disease and pressure from U.S. Sen. Bernie Sanders lead to the approval of a rival treatment? That’s what Florida-based Catalyst Pharmaceutical is attempting to show in court.
Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization
Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration for clearance of the test under the emergency use authorization.
The therapy was also granted Rare Pediatric Disease designation for neuronopathic Gaucher disease, the most severe form of the condition.
Steve Hoerter, president and chief executive officer of Deciphera, said the acceptance of the NDA brings the company one step closer to its goal of providing a new treatment option for patients with advanced GIST.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.