FDA approval

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.

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

AstraZeneca failed to win FDA approval for its potential heart drug Brilinta, a drug the company -- which is about to face a severe patent cliff -- had high hopes for. Shares in the U.K. drugmaker dropped in London and were over 5% lower in premarket trading in New York.

AstraZeneca's Heart Drug Brilinta: The FDA Is Ready to Rule

More than a year after AstraZeneca filed for approval of its heart drug Brilinta, 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.

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.

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.

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.

FDA Sends Warning Letters to Electronic Cigarette Makers

The FDA issued warning letters to five electronic cigarette distributors, saying the products are being marketed illegally as safer alternatives to smoking and even as smoking-cessation aids. The agency says they must seek FDA approval in order to continue making those claims.

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.

Weight-Loss-Drug Maker Vivus Soars on FDA Review

An expert panel will review Vivus' potential blockbuster drug Qnexa on Thursday, with the FDA making a decision in October. The FDA acknowledges the drug's effectiveness in cutting weight, but it will certainly draw scrutiny over its side effects.