Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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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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Marion Gruber, director of the agency’s Office of Vaccines Research & Review is leaving at the end of October. Phil Krause, OVRR’s deputy director, is exiting in November.
Two former executives of JHL Biotech were indicted on charges of orchestrating the theft of trade secrets, wire fraud exceeding $101 million, and money laundering.
The bill may lead to a 15% to 25% reduction in expected returns for drugs in the top quintile of expected returns. Meaning a decrease in new medications entering the market in the following years.
An alleged plan by Johnson & Johnson to spin off a company solely responsible for its talc-based products in order to mitigate lawsuit damages is still on the table following a ruling by a federal judge.
Gilead won the most recent battle when a U.S. appeals court threw out a $1.2 billion ruling against the company.
The CDC is taking a proactive stance and establishing a center that will use forecasting and outbreak analytics to guide public health decision-making.
The petition was posted on Monday by shareholder rights law firm Labaton Sucharow.
Studies are also continuing on the value and efficacy of booster shots, particularly against the Delta variant. Read on for more information.
The report also highlighted that an unvaccinated individual is five times more likely to get COVID-19 than someone who is fully vaccinated.
Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. FDA.