Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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The U.S. Securities and Exchange Commission has launched an investigation into Texas-based Cassava Sciences.
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the company’s Marketing Authorization Application for Aduhelm.
While COVID-19 appears to be surging again in the U.S. and Europe, the government is spending billions to acquire antibody and antiviral therapies and edging toward vaccination boosters.
Pfizer’s oral antiviral treatment for COVID-19 is making its way through regulatory hurdles. The company is working with global manufacturers to ensure a steady supply of the medication.
Thanks partly to Biogen’s pricey new Alzheimer’s drug, Medicare enrollees will be burdened with higher monthly premiums for their Part B coverage.
President Joe Biden has nominated former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm.
Moderna responded to claims that the government should be co-patent owners of the mRNA vaccine developed by the company and said its mRNA sequence was exclusively selected by Moderna scientists.
Houston-based money manager Alan Eisenman testified in the ongoing Elizabeth Holmes fraud trial that he sought “straight answers” about the company’s work for several years.
Between January 4, 2020 and October 30, 2021, COVID-19 accounted for 576 deaths among children 17 and younger, compared to 189 from influenza, according to the CDC.