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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AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.
Court documents outline J&J’s involvement in a dermatology experiment 50 years ago on incarcerated individuals, most of whom were African American.
China has become a leader in biotech in the last five years, especially in CAR-T therapies. Companies like Johnson & Johnson are on the prowl to acquire Chinese companies to form collaborations.
Robert Califf became the new commissioner of the U.S. Food & Drug Administration and emphasized the use of real-world evidence (RWE) in Agency decisions.
Several cases of Japanese encephalitis have been confirmed in Australia and may have spread from pigs to humans, although it can also spread from horses.
As COVID-19 cases fall in the wake of the latest surge from the Omicron variant, the question on the minds of many is, what comes next for these Pfizer and Moderna?
The FDA turned down Ocugen’s Emergency Use Authorization request for Covaxin in children 2 to 18, which the company is co-developing with India’s Bharat Biotech.
Members of the Sackler family will dedicate at least $5.5 billion plus 100% of the debtors’ assets to opioid abatement and victims.
On Wednesday, Massachusetts-based ConforMIS said it was suspending all distribution of its orthopedic medical devices to Russia and any Russian-based entities.
President Biden announced updates to the “Test to Treat” initiative that will allow people to get tested for COVID at a pharmacy and receive a treatment round of Pfizer’s Paxlovid at no cost.