Category: Drugs

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
Bad news on the Alzheimer’s drug development front: Pfizer and Medivation announced negative results from a large late-stage trial of Dimebon, thought to be a promising treatment more potent than those currently on the market.
Dimebon, you may remember, got its start a quarter-century ago as a Russian cold medicine that Pfizer plunked down […]

JGrimes
It seemed like only a question of time, but Bristol-Myers Squibb said this afternoon that Lamberto Andreotti, its president and chief operating officer since last March, would succeed James M. Cornelius as CEO.
Andreotti, a 12-year veteran of the company, is 59 years old and Cornelius is 66. Cornelius was tapped as Bristol-Myers CEO […]

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 […]

JGrimes
New Novartis chief Joe Jimenez (right) is looking at beefing up some business segments with acquisitions, but has nothing in mind as big as its $39.3 billion plan to buy the rest of eye-care company Alcon.
“We may go for smaller, bolt-on acquisitions to help build scale in vaccines, generics and consumer health, but […]

noreply@blogger.com (RCoffield@fsblaw.com)
Patients concerned about side effects associated with aspirin, particularly the risk of gastrointestinal problems such as ulcers, often try taking versions of the drug that are coated with enteric.
Though patients often believe these pills pose a lower risk of stomach upset, they actually don’t appear to have much effect on the more […]