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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Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT is of paramount public importance and demands that the FDA make the data publicly available within eight months.
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
The indictment against the scientists point in specific to GSK’s code of conduct, which prohibits any company information from being shared externally without approval.
Elizabeth Holmes, the founder and former CEO of Theranos, has been found guilty of bilking hundreds of millions of dollars from investors to prop up her company.
Teva Pharmaceuticals will appeal a potential $1.5 billion judgment against the company in the state of New York for its alleged role in the opioid epidemic.
Janssen Pharmaceutical has recently applied for Biologics License Application for its relapsed or refractory (r/r) multiple myeloma drug. Here’s all about it.
Part of what is being discovered about the Omicron variant of COVID-19 is how fast it appears to infect people, a median of about three days, compared to four or five with other variants.
Collegium reached a $2.75 million agreement with a law firm representing 27 U.S. cities, counties and subdivisions related to the opioid crisis and the company’s sale of Xtampza.
Dr. Charles Lieber was convicted Tuesday by a federal jury after being found guilty of lying to the U.S. government about his questionable ties with the People’s Republic of China.
The government charged Chicago-based Daniel V.T. Catenacci, a medical school professor who served as the lead investigator of the company’s cancer drug bemarituzumab.