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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BioSpace talked with Paul Mango, one of the key leaders of Operation Warp Speed, about the experience.
Pfizer will cease operations within Russia and proceeds from its subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine.
The Russian invasion of Ukraine has hampered Ukrainian research to develop new treatments for infection from the SARS-CoV-2 virus and increased the risk of spreading virulent pathogens.
The death toll related to COVID-19 is more than 6 million, according to the Johns Hopkins COVID-19 dashboard, but it has long been suspected that the toll is significantly higher.
The SEC said that Yum China, BeiGene, Zai Lab, HutchMed and ACM Research are all at risk if they do not give U.S. regulators access to their audit records.
Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results and said the company stopped efforts on its COVID-19 vaccine.
More than two dozen people were given the opportunity to confront members of the Sackler family in a virtual environment and share the impactful pain opioid addiction caused their families.
This target date is the latest development in a long series of setbacks that Acadia - and other pharma companies - have experienced getting Alzheimer’s treatments approved.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Pfizer has launched a Phase II/III study to assess its oral antiviral Paxlovid in non-hospitalized symptomatic pediatric patients who are at risk for progression to serious disease.