A group of bipartisan members in the House of Representatives introduced a bill late Thursday that aims to combat the growing threat of so-called "superbugs" by essentially providing a fast-track route to FDA approval for promising new antibiotics and antifungals.
Its expansion to Europe--and "other markets worldwide in the near future"--underscores Smith & Nephew's commitment to find growth in its wound dressing unit, as its core businesses in knee and hip replacements make their way through a turnaround.
Two years after a stinging rejection at the hands of the same committee, Bristol-Myers Squibb and AstraZeneca got a warmer reception for their diabetes drug dapagliflozin, winning a recommendation from an FDA advisory panel and brightening their odds of approval for the once-rebuffed therapy.
Merck convinced a panel of FDA advisers that its oral grass allergy immunotherapy could successfully reduce symptoms, but the pill may well face an uphill battle if it can make its way onto a market dominated by effective injections.
It's well-documented that antibiotic resistance is a growing public health threat. Drug-resistant bacteria infect about 2 million Americans a year, causing at least 23,000 deaths, according to CDC data. Now, to keep resistance from mounting, the FDA is rolling out a plan to cut down on antibiotics use in livestock, enlisting the drugs' producers--companies like Eli Lilly and Zoetis--to help them do it.
Bristol-Myers Squibb's rare disease treatment metreleptin isn't up to snuff for its desired indication, an FDA committee voted, but agency advisers believe the drug shows some promise in a small subset of patients, giving the drug giant some hope for approval.
St. Jude Medical won a long-awaited CE mark for a larger size of its Portico transcathether aortic heart valve implant, a milestone that expands its overseas market reach and ups competitive pressures on rivals Edwards Lifesciences, Medtronic and Boston Scientific.
When Congress boosted the FDA budget last year to station inspectors in other countries like China, where weak oversight has allowed tainted drug ingredients (and pet treats) into the U.S., China blocked visas for the new regulators. Now, with some intervention from the vice president of the United States, the logjam has been broken.
As an 11th-hour budget deal shapes up for votes in the House and Senate this week, AdvaMed president and CEO Stephen J. Ubl lauded parts of the agreement that call for relief of the FDA user fee sequestration.
The FDA has shrugged off Sprout Pharmaceuticals' female libido drug, further delaying the years-long quest to develop a Viagra equivalent for women, but the drugmaker is appealing the rejection, arguing that the agency is misunderstanding how to measure efficacy.