FDA approval
FDA Approves First New Lupus Drug in Half a Century
The Food and Drug Administration on Wednesday approved the first new drug to treat lupus in 56 years. It's not terribly effective: It only worked for 35% of the patients tested. But experts say the approval could prompt the development of more effective drugs.
It's Getting Harder to Come Up With a Successful Drug
The odds of shepherding a new drug to market in recent years has fallen to nearly one in 10 -- about half of the previous rate, according to a new study released this week. First, a new treatment must survive several layers of clinical studies -- and then the FDA approval process. That trip is getting tougher.
Two Reasons for Clinical Data Shares to Soar Again
From October 2010 to February 2011, biotech Clinical Data's stock doubled, mostly thanks to FDA approval of its novel antidepressant. But also pushing the stock up -- and making it likely to perhaps double again -- is speculation that a Big Pharma will buy Clinical Data.
FDA Rejects Orexigen's New Diet Drug Over Heart Concerns
In a surprise move Tuesday, the FDA rejected Orexigen's proposed new diet drug Contrave, saying the company needed to run another study of its cardiovascular risks. With this rejection, all three of a slate of similar diet drugs from competing pharmaceuticals have been turned back by the agency.
AstraZeneca's Brilinta Fails to Win FDA Approval
The FDA disappointed AstraZeneca and its investors by not approving its heart drug Brilinta, a blood-thinner that the company -- facing a severe patent cliff -- has high hopes for. If approved, it could be a multibillion-dollar blockbuster. But the FDA wants to see more analyses of results from a major study.
AstraZeneca's Heart Drug Brilinta: The FDA Is Ready to Rule
More than a year after AstraZeneca filed for approval, the FDA will make its decision on Thursday. A large study showed the blood thinner worked better than Plavix for treating acute coronary syndrome -- but approval isn't a sure thing, due in part to some oddities in the study's results.
Tiny Spectrum Pharmaceuticals Is Getting Plenty of Attention
What's Spectrum's particular allure? Beyond being the subject of takeover rumor, it has two oncology drugs approved by the Food and Drug Administration that are already on the market, plus two other promising drugs that are in late-stage clinical trials.
FDA Considers Weight-Loss Implant for the Barely Obese
Allergan's Lap-Band, a device implanted in the stomach to limit the amount of food that can be ingested, is already on the market to help the very obese lose weight. But now the company hopes to win approval for less obese patients to use the band.
Osteoporosis Drug Approved for Cancer Patients
The FDA has approved Amgen's osteoporosis drug denosumab for use by cancer patients with solid tumors whose disease has metastasized to their bones. The indication to prevent complications such as fractures and bone pain among those patients could boost the drug's sales by billions.
How to Approve 'Biosimilar' Drugs? The FDA Has to Figure That Out
Unlike generics, which are the exact chemical copies of a brand-name drug, biosimilars have large and often complex proteins that are made in living cells, and tiny differences can play havoc with the product. It may take years for the FDA to create an approval process.
Pfizer Makes Headway in the Fight Against Lung Cancer
Pfizer's cancer drug crizotinib was able to shrink tumors of non-small-cell lung cancer patients whose tumors carried a specific genetic mutation that fuses two genes. The early-stage study results were published in the New England Journal of Medicine.
Lilly, Amylin, Alkermes Shares Get Crushed After FDA Rejects Diabetes Drug
Shares of pharmaceutical companies Amylin, Alkermes, and Eli Lilly -- partners in a new diabetes drug Bydureon -- have tanked in morning trading as the U.S. Food and Drug Administration declined on Tuesday to approve the drug without additional clinical studies.
Alcoholism Drug Vivitrol Approved for Narcotics Addiction
Drugmaker Alkermes said Tuesday it has received U.S. approval to market its addiction medication for use in patients addicted to narcotics like heroin and morphine. Vivitrol, a monthly injection, is already approved for alcoholism.
FDA Rejects Jazz Pharma's Potential Fibromyalgia Drug
Jazz Pharmaceuticals shares slumped more than 5% in premarket trading Monday after the company announced that the FDA had denied approval for its fibromyalgia treatment, sodium oxybate. While approved to treat narcolepsy, sodium oxybate is illegally sold as the party and date rape drug GHB.