Category: FDA

JGrimes
Getting one drug through the FDA approval process is hard enough but getting the go-ahead for multiple medicines at once so they can be used together in so-called drug cocktails can be Herculean.
Now the agency is devising guidelines to speed up testing and approval of multidrug regimens for some of the world’s most […]

JGrimes
Boston Scientific is back in the regulatory doghouse after the medical-device maker failed to report to the FDA changes in how it manufactures its line of implantable heart defibrillators
The company has recalled the devices and halted further shipments until it resolves the reporting issue with the FDA. The business accounts for 15% of […]

JGrimes
The FDA says it added its strongest warning today to the label of the widely used bloodthinner Plavix, Bristol-Myers’ best-selling drug, to help physicians treat patients correctly. But the warning could make doctors’ job more difficult.
Docs prescribe Plavix to reduce the risk of heart attacks, strokes and other serious heart problems. The […]

JGrimes
There have long been safety questions — and lawsuits — over whether bone-building drugs like Merck’s Fosamax can actually increase the chance of femur fractures. Today, the FDA said it was going to take another look at the safety issues.
In a posting on its Web site, the FDA said a 2008 examination of […]

JGrimes
The Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.
FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug […]

JGrimes
Another day, another stock-price jump.
First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.
The FDA is expected to decide by early May whether to go along with the panel’s recommendation on […]

JGrimes
The FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.
The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage […]

JGrimes
The FDA plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report, the WSJ said this morning.
In a letter to Sen. Chuck Grassley, the FDA says an internal […]

JGrimes
All is not well in the land of insulin pumps — the devices that deliver insulin to mostly Type 1 diabetics — and the FDA wants to put a spotlight on the problem.
Noting that there had been 18 recalls of pumps over five years because of hardware and software problems, the FDA said […]

JGrimes
In what could be a win-win decision for both Teva Pharmaceutical and Merck, a federal court said that Teva was entitled to six months of exclusivity to sell generic versions of two hypertension medicines made by Merck.
A district court ruled in July that Teva, the largest of the generic drug makers, had forfeited […]