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Before the bell this morning, the ever-popular Dendreon put out a press release ahead of its presentation later today at the Bank of America Healthcare Conference in Las Vegas. You can listen to the presentation via Webcast at 1 p.m. ET. The company says that the Food and Drug Administration has confirmed that it will "accept either a positive interim or final analysis of survival" from the ongoing, larger clinical trial on Dendreon's highly controversial prostate cancer treatment Provenge.
Wyeth's drug Torisel won U.S. approval to treat patients with a type of advanced kidney cancer known as renal cell carcinoma, the Food and Drug Administration said.
A warning issued to MedImmune over manufacturing issues at a United Kingdom plant shouldn't significantly disrupt company production of its nasal spray flu vaccine, federal health officials said.
Vegetable oils, salad dressings, crackers and other oil-containing foods made by PepsiCo's Frito-Lay unit will now carry claims that products with unsaturated fat can curb heart disease risk, U.S. regulators said.
In the middle of the Avandia blowup, GlaxoSmithKline this week is launching the new over-the-counter diet pill "Alli." The company says it's spending 150 million bucks on the first-year marketing of the formerly prescription-only Xenical from Roche.A big chunk of that is going toward a multi-pronged educational campaign to convince dieters they have to change their eating habits and exercise if they want to get the maximum benefit from Alli. That's crucial with this drug because the more fat you eat, the worse the gastrointestinal side effects. Clue: Glaxo is telling Alli users to wear dark pants and bring an extra pair to work. The company has gone so far as to set up an exhibit in New York City this week where people can get more information about Alli.
Women looking for a simple way to avoid their menstrual period could soon have access to the first birth control pill designed to let women suppress monthly bleeding indefinitely.
So, let's start with GlaxoSmithKline's Avandia. The stock is rebounding a little bit today after the pummeling it took yesterday. Once again, the New England Journal of Medicine study saw an "embargo break" by another media outlet. That means the news hit in the middle of the trading day yesterday, catching just about everyone by surprise. The embargo was supposed to have lifted at 5 p.m. ET yesterday, which would have given all of the stakeholders -- chiefly Glaxo -- the ability to issue their prepared press releases at the same time.
While I'm watching the webcast of the FDA Advisory Committee Meeting on the anemia drugs (Amgen, Johnson & Johnson), I wanted to hop on my TV versus print soapbox one more time.As I posted yesterday, I had asked a Dendreon spokeswoman for an interview with CEO Dr. Mitchell Gold in the wake of the FDA sending the company an "approvable letter" for its prostate cancer treatment Provenge.
Shares of Biotech drug maker Dendreon sank more than 50% after the FDA requested more clinical data on the effectiveness of its prostate cancer treatment, Provenge, delaying the drug's approval.
GlaxoSmithKline's Alli (pronounced "ally" -- don't ask me why they put an "i" at the end) is the new over-the-counter version of prescription Xenical from Roche. It's a diet pill, but as I previously blogged, it has potentially embarrassing side effects. On the plus side, GSK says you can subtract 50% more pounds if you use Alli as directed. But, if you still eat too many fatty foods, you could run into trouble.
Analysts have projected peak sales of up to $1 billion a year for the allergy treatment, which is chemically known as fluticasone furoate.
The decision was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.
Eli Lilly announced Wednesday it has received approval from the FDA to market Reconcile, the first selective serotonin reuptake inhibitor (SSRI) class of antidepressants approved by the FDA for treatment of canine separation anxiety in conjunction with behavior modification training.
Mylan Laboratories spacer said U.S. regulators approved its generic version of Sanofi-Aventis' sleeping pill, Ambien, in the 5 mg and 10 mg strengths.
A bird flu vaccine made by Sanofi Aventis is the first to gets federal approval as a stopgap measure against a potential pandemic until more effective vaccines can be developed.
Boston Scientific said on Monday it had resolved deficiencies that U.S. regulators had found at a plant that manufactures heart rhythm devices, sending its shares up nearly 7%.
Merck's new pain reliever drug Arcoxia, which was proposed as a successor to Vioxx, was rejected by a federal health advisory panel. A Food and Drug Administration drug safety expert earlier told the panel that the drug may increase substantially the risk of stroke and heart attack and is no more effective for pain relief than other medicines in the same class.
An analyst sounded a warning note on shares of biotechnology company Dendreon on Monday, which have more than tripled in value since March 30, but the stock continued to rise.
The Food and Drug Administration doesn’t have the staff to inspect all food imported to the U.S., raising basic health concerns and forcing consumers to take producers' word that it’s safe, a food expert said.
Shares of Dendreon shot up after a panel of FDA advisers voted Provenge is both safe and effective in treating advanced prostate cancer.