Orshe

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.

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.

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.”

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.

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.

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:

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.

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 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.

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.)