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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Alnylam is suing Moderna and Pfizer over patent infringements related to its lipid techQnology that have been foundational to the success of the mRNA-based COVID-19 vaccines.
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
On Wednesday, the World Health Organization indefinitely postponed the evaluation of Russia’s Sputnik V COVID-19 vaccine due to the ongoing conflict in Ukraine.
In his new book, Warp Speed, Paul Mango said the realization that many healthcare workers didn’t want the vaccine, for instance, was shocking.
After reviewing the trial’s Independent Data Monitoring Committee, the EMPA-KIDNEY trial announced it would stop early as it met prespecified criteria for positive efficacy.
Two former executives of JHL Biotech were sentenced to a year and one day each in prison after being found guilty of conspiracy and fraud.
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment.
More pharmaceutical companies are joining to put economic pressure on Russia by suspending some or all operations within that country following the invasion of Ukraine.
Now that Omicron is becoming less common, its sister variant, BA.2, seems to be surging worldwide and in the U.S. For that and more, continue reading.