NEW YORK – With Congress’s end-of-year legislative deadline closing in, the fates of two bills that could significantly impact the lab industry remain up in the air. Lawmakers continue to wrangle over whether to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act — which would give the US Food and Drug Administration authority over…
Last summer, when Boston cancer surgeon Monica M. Bertagnolli heard she might be selected to lead the National Cancer Institute, she asked a friend whether she would be able to do the job. It was a disarming display of humility from an accomplished professional who has removed gastrointestinal tumors as big as pumpkins and herded…
A band of medical device, public health, and patient and consumer advocacy organizations are pressuring Congress to pass a key diagnostics reform bill in a year-end package as the deadline for funding the government looms and talks of a potential longer term continuing resolution ramp up. The bill at issue, the Verifying Accurate Leading-edge IVCT…
HUMIRA RAISES ATTENTION ON BIOSIMILAR MARKET — The first copycat alternatives to a blockbuster anti-inflammatory drug will hit the U.S. market next year, marking an important moment for the drug and insurance industries as they determine how biosimilar products for one of the top-selling brand names will be priced, Lauren reports. Biosimilars to Humira will roll out…
WASHINGTON – Theranos, and the company’s notoriously inaccurate blood tests, could potentially have been stopped earlier if Congress had acted to fix a regulatory loophole. Lawmakers are weighing now whether it’s better late than never. Key decisionmakers in Congress are closer than they’ve been in years to revamping the way the government regulates some of…
The US Food and Drug Administration’s oncology and device groups are working together to set minimum standards for cancer diagnostics that all sponsors can use. Oncology Center of Excellence Director Richard Pazdur said the pilot program in the works with the Center for Devices and Radiological Health would add criteria for tests to clinical trials.…
The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG and other drugmakers to remake plans for their drugs or pull them from the market. Under the accelerated-approval program, the FDA clears the use of prescription medicines faster than it normally would. The agency…
The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research. “Given the amount of existing data, it doesn’t have to be a trial that asks…
The phase III trial evaluating the efficacy of ramucirumab plus pembrolizumab in non-small cell lung cancer establishes a new paradigm for clinical trial design. The word “streamlining” is heard with increasing frequency in oncopolitics these days, as NCI, FDA, industry, academia, and advocacy groups push back on clinical trials that, to quote the FDA Cancer…
Pragmatica-Lung is the first of what is likely to be a series of simpler trials with relaxed enrollment criteria and streamlined data collection requirements. The results of such trial would be more generalizable to real-world patient populations. “How do we make these trials simpler? We don’t need a 50-100-page document. We want to try to…
