Truly innovative devices that do not have a substantially equivalent predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices.
GlaxoSmithKline may be suffering from R&D setbacks, generic competition and corruption investigations in a dozen countries, but its HIV-oriented venture ViiV Healthcare is racking up new OKs. Friday, the company scored the FDA's blessing for a combo drug pegged at $5 billion in peak sales.
Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.
The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.
ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, picked up FDA approval for a single pill that combines three antivirals and promises to challenge a leading treatment from Gilead Sciences.
The FDA is coming down on drug compounder Wickliffe Pharmaceuticals for poor compliance to manufacturing practices after receiving a report that two horses died following adverse reactions to drugs produced by the Lexington, KY-based operation.
Beleaguered Indian drugmaker Ranbaxy Laboratories set aside about $40 million in its last quarter for "ongoing settlement discussions." Now sources are suggesting the drugmaker's need for the funds: a settlement with the state of Texas.
Pfizer and Bristol-Myers Squibb's Eliquis has been lagging since launch time, trailing behind predecessors Pradaxa and Xarelto. But lately, the drugmakers' efforts have been paying off when it comes to market share, and a new indication may help keep the ball rolling.
AliveCor announced Aug. 21 that it has received FDA clearance for an algorithm to detect atrial fibrillation, and next month it plans to incorporate the new ability into its AliveECG app for monitoring the heart.
Lexington, MA's Cubist Pharmaceuticals is inching toward its second drug approval of the year, hoping to win European and U.S. clearance for a new anti-infective as analysts wonder whether the company is in line for a Big Pharma takeout.