Policy
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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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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President Biden called for the U.S. Senate to approve his Build Back Better legislation to reduce the cost of prescription drugs provided through Medicare.
CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
The speakers extolled the benefits of telehealth while noting the challenges posed by a lack of high-speed Internet in some parts of the country.
kENUP had called the mRNA vaccine efforts in Africa “doomed to fail” since the project likely infringes on BioNTech and Moderna patents on the vaccine.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
As AstraZeneca released its 2021 annual financial report, a BBC documentary suggested that the way scientists and politicians politicized its COVID-19 vaccine may have cost lives.
It’s uncertain if the origins of COVID-19 will ever be determined, but the current top theories split about evenly between a lab leak from the Wuhan Institute of Virology and a natural evolution from bats to animals to humans at a Wuhan “wet market.”
The FDA is slowing down the process of potentially approving dozens of new medications initially developed for the Chinese market.
WuXi Biologics was amongst those on the list, with the U.S. stating that it was unable to verify the legitimacy and reliability of the company in its use of U.S. exports.