Clovis Oncology, whose market value has plummeted by more than 80% over the past year, has secured a date with FDA advisers to make the case that its lung cancer treatment merits approval despite some disappointing data.
While much of the news in recent months on warnings issued by the U.S. Food and Drug Administration centered on alerts issued to Indian pharmaceutical manfacturers, active pharmaceutical ingredient and drug manufacturers in China have also received their own set of alerts under the FDA's Form 483 regime, according to a report by the Regulatory Affairs Professionals Society.
Research is advancing rapidly to validate imaging and blood biomarkers that can easily identify concussions and other traumatic brain injuries on the battlefield, in the sports arena and in emergency care rooms. The FDA demonstrated that the issue is a top priority for it by setting up a public meeting on March 3 to address the scientific developments, regulatory challenges as well as big data standardization, sharing and analysis issues raised by the hunt for TBI biomarkers.
Imprimis Pharma is striking out at notorious price hikes once again. The compounder that rolled out a cheaper alternative to toxoplasmosis treatment Daraprim now plans a cut-rate rival for the suddenly pricey kidney drug Thiola.
The U.S. Food and Drug Administration rejected more than 13,000 products made in India in the 5 years between 2010 and 2015, according to FDA data cited in an Economic Times report, and rejected slightly more than 15,000 products made in China.
The FDA intends to change the way it handles plant inspections, using metrics to suggest which plants may be having issues and making more frequent trips to those that appear at risk. While those companies committed to quality may be rewarded for their efforts, a new report warns that those that are already struggling with quality can expect to be more under the thumb of regulators.
Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.
FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency.
The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Calif, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.
The pharma industry heralded 11 new blockbusters in 2015, an act that's tough to follow. But while 2016 may not see quite that many, it's still on track to ring in 7 new therapies that have a shot at cracking the billion-dollar sales mark, a new analysis says.