Drugs

Drug Safety Data Threat Growing: PwC Report

A PriceWaterhouseCoopers Health Research Institute (HRI) report says the drug industry is facing a growing threat from safety data on drugs being produced. “FDA has fostered unprecedented transparency on drug safety data,” the report says, “forcing companies to manage novel challenges from parties already busy mining those data: regulators, the public, and data analytics firms. In this climate, pharmaceutical companies have the opportunity to find ways to mitigate risks, unlock savings, make new discoveries, and create competitive advantages.”

Changes made by FDA identified in the report include increased transparency, requiring electronic submission to the agency of adverse events reports, increasing cooperation with global regulators, and new regulatory authority to approve drugs more quickly.

“These changes come as FDA prepares to use new approaches to approve products more quickly using new types of data,” the report says. “Drug safety data will play an even bigger role in determining which products succeed.”

The report’s HRI impact analysis covers:

companies’ use of data to gain competitive advantage, including finding new uses and indications for drugs, predicting safety issues in other products, designing better clinical trials, and assessing drugs’ economic impact;
using automation and artificial intelligence to analyze increasing volumes of structured and unstructured adverse event data more rapidly; and
using data to manage risk and become a value-producing safety organization.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome