Posts Tagged ‘Fda’
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Wednesday, March 10th, 2010 at 10:23 | Comments Off
InterMune’s Lung Drug Gets Backing From FDA PanelCategories: Wall Street Journal
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 pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.
This all comes as good news for ..read more
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Wednesday, March 3rd, 2010 at 08:20 | Comments Off
Teva Gets 180-Day Headstart to Sell Generics of 2 Merck DrugsCategories: Wall Street Journal
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 the 180 days of exclusivity that usually goes to the first applicant seeking FDA approval to make a generic versions of drugs — in this case, ..read more
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Tuesday, March 2nd, 2010 at 08:51 | Comments Off
Microsoft Hires Ex-Regulator in Health PushCategories: Wall Street Journal
You probably wouldn’t put Microsoft on the list of companies in the market to hire former FDA officials, but the software giant snagged a top medical-device regulator today.
Donna-Bea Tillman, head of the office of device approvals, says her jump to Microsoft isn’t as unusual as it may seem. She told colleagues in a memo she has long had “a love for all things computer.”
Tillman elaborated in an interview with the Health Blog, saying she moonlighted writing software programs for engineering ..read more
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Friday, February 19th, 2010 at 06:53 | Comments Off
FDA Discourages Use of Some Asthma Drugs After Years of ReviewCategories: Wall Street Journal
Safety experts advising the FDA have been sending up flares about various asthma drugs for several years. In 2007, a panel said GlaxoSmithKline’s Serevent and Advair should carry a warning about risks to children. In 2008, experts said Serevent and Norvartis’s Foradil shouldn’t be used for asthma any more.
Today, the FDA itself said it had heard enough. The agency said it plans to impose new “safety controls” over those three drugs as well as AstraZeneca’s Symbicort, warning that they ..read more
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Tuesday, February 16th, 2010 at 13:21 | Comments Off
As Food-Safety Push Grows, Consumers Sort Out Dos, Don’tsCategories: Wall Street Journal
With new food-safety legislation making its way through Congress, safety advocates are hoping the FDA will soon have sweeping new powers to protect the nation’s food supply, as I write in the Informed Patient column today.
But in the debate over how to make food safer, it can be tough for consumers to figure out what’s safe to eat. Take a study released earlier this month by Consumers Union, which analyzed 208 samples of bagged, pre-washed salad, and reported ..read more
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Wednesday, February 10th, 2010 at 00:47 | Comments Off
Cholesterol Drug Approved for People Without High CholesterolCategories: Wall Street Journal
Statins’ global conquest continues. The class of cholesterol drugs already includes Pfizer’s megablockbuster Lipitor as well as simvastatin, the hugely popular generic that Merck sold under the brand name Zocor.
Now, AstraZeneca’s statin Crestor has crossed a new threshold: It’s the cholesterol drug for people who don’t have high cholesterol.
The FDA just expanded the drug’s approval to include reducing the risk of heart attack and stroke in people who meet all of the following criteria:
Older than 50 for men, older than ..read more -
Tuesday, February 9th, 2010 at 04:43 | Comments Off
Tough Questions Await Cell Therapeutics’ Cancer DrugCategories: Wall Street Journal
Cell Therapeutics’ experimental lymphoma drug pixantrone faces rough sledding from an FDA advisory committee after an agency staff review raised questions about the drug’s effectiveness and side effects. The news sent the company’s shares sharply lower.
One of the chief studies of the drug was supposed to involve 320 patients but only 140 were enrolled. Cell Therapeutics told the FDA it had trouble finding participants for the study because doctors preferred to use multiple chemotherapy drugs or supportive care, Reuters said, ..read more
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Thursday, January 28th, 2010 at 09:37 | Comments Off
Pfizer Offers First Look Inside Its Post-Merger PipelineCategories: Wall Street Journal
Pfizer gave its first pipeline update since it took over Wyeth in October. Bottom line: The company now has has about 500 products somewhere along the path between early-stage human trials and registration, down from about an initial 600 in the combined company’s pipeline.
The company also announced it had dropped its bid to combine its Lyrica pain medication with other treatment for generalized anxiety disorder. Lyrica is already approved for fibromyalgia. Pfizer recently failed to win FDA approval to ..read more
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Saturday, January 23rd, 2010 at 10:06 | Comments Off
What the New MS Drug Does (and What It Doesn’t Do)Categories: Wall Street Journal
The FDA just approved a new multiple sclerosis drug called Ampyra. The drug (also known as Fampridine-SR) helps some patients walk faster.
Trouble walking is a serious problem for many MS patients. But only a minority of patients seem to benefit from Ampyra. In one study, 35% of people who took the drug showed improved walking speed, compared with 8% of those who took a placebo. In another study, 43% of patients showed improvement, compared with 9% who took a placebo.
Still, ..read more
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Thursday, January 7th, 2010 at 06:29 | Comments Off
Can a Japanese Cloth Company Make Drugs? FDA Says YesCategories: Wall Street Journal
What kind of company gets a drug through the FDA? If you’re a Japanese company, it seems to help if your main business isn’t prescription pharmaceuticals.
Perusing the list of FDA new drug approvals from Washington Analysis, we found four that originated in the labs of Japanese companies. A new drug for gout came from Teijin, a major textile maker. (Teijin licensed U.S. rights to Takeda.)
The Otsuka group of companies, best known in some circles as the maker of ..read more

