food and drug administration

Johnson & Johnson Recalls Leaky Insulin Cartridges

Johnson & Johnson has issued another recall, and this time, it's not over a typo. The company's Animas unit recalled five lots of leaking insulin cartridges whose use could lead to serious health problems. The 2-milliliter cartridges can leak, resulting in the delivery of less insulin than intended.

Japan Finds No Link Between Vaccines and Child Deaths

Japan's health ministry says it's continuing its suspension of pediatric vaccines made by Pfizer and Sanofi-Aventis, despite finding no direct link between the vaccines and the deaths of four children. Both drugmakers are cooperating with the government and expect to be cleared.

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.

Senators Propose a New Law to Address Drug Shortages

Health care providers have been reporting unprecedented shortages of prescription drugs, including vital medications such as chemotherapies and antibiotics. Under current law, the FDA has no power to act, so two senators have introduced a bill to help government get a handle on the problem.

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.

Pharma News Briefs: Human Genome, Merck, Novartis

Here's a roundup of some of Wednesday's major pharmaceutical news: An FDA panel gave Human Genome Sciences a boost with a thumbs-up for its lupus drug, Benlysta; Merck's experimental heart drug appears to work well without side effects; and Novartis announced its plans for long-term growth.

Of Four Loko and Student Loans: An Accountability Crisis

Under the threat of an FDA ban, the makers of alcoholic energy drink Four Loko are changing its recipe to remove caffeine, guarana and taurine. But the only problem a ban of Four Loko would solve is to save young people from thinking they have personal responsibility for their choices -- again.

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.

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.

Abbott Pulls Weight Loss Drug Meridia from Market

Drug and medical-device maker Abbott Laboratories announced Friday that it will voluntarily withdraw its controversial obesity drug Meridia, (sibutramine) from the U.S. market at the request of the FDA, due to concerns it increases the risk of heart attacks and strokes.

Novartis Halts Two Drug Development Programs

Swiss pharmaceutical company Novartis announced Tuesday that it had discontinued the development of two drugs -- the hepatitis C treatment Zalbin, and antifungal agent Mycograb. The company will take impairment charges of approximately $590 million in third quarter of 2010.

Roche's Avastin Fails in Early-Stage Colon Cancer Study

Roche's top-selling cancer-fighting drug Avastin has hit another roadblock in testing. In a Phase III study, Avastin failed to improve disease-free survival in early-stage colon cancer patients, the pharmaceutical giant reported.

Allergan Pays $600 Million to Settle Botox Charges

Pharmaceutical firm Allergan has settled criminal and civil charges that it promoted Botox for uses the FDA hadn't approved, agreeing to pay $600 million and enter into a "corporate integrity agreement." Allergan also dropped its related First Amendment lawsuit against the FDA.

Jazz Shares Fall After FDA Panel Rejects Fibromyalgia Drug

Share of Jazz Pharmaceuticals shares sank over 24% in early morning trading Monday after an FDA advisory panel rejected its proposed fibromyalgia drug, Xyrem, Friday. Though Xyrem appeared to help some patients, the panel found the benefits didn't outweigh the risks.

Deutsche Bank Initiates Coverage of Biotech Stocks

Several biotech stocks were on the move Monday after Deutsche Bank initiated coverage on some of them. The bank's analyst, Robyn Karnauskas, took a generally wary view on the biotech sector, only putting buy ratings on Gilead and Dendreon.

FDA Eyes Overhaul of Medical Device Regulation

The Food and Drug Administration is proposing to revamp its regulations of medical devices, the agency said Wednesday. While seeking to improve device safety, the FDA also wants to ease the regulatory environment and foster innovation. But the proposals have the industry concerned.

Dangerous dietary supplements?

A new report by Consumer Reports Magazine says dietary supplements sold in the U.S. are often contaminated and may cause serious health...