amgen

The Problem with Fast-Tracking Drug Approvals: Pharmas Fail to Follow Up

To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials than usual. But it turns out that many of the pharmaceutical companies fail to conduct follow-up trials to prove the drugs work.

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.

Amgen, J&J Recall Procrit, Epogen for Possible Glass Issue

Drug-makers Amgen and Johnson & Johnson are voluntarily recalling two brands of an injectable anemia medication because of the possibility that vials of it may also contain tiny glass flakes. The drug, Epoetin alfa, is marketed under the brand names Epogen and Procrit.

Atlantic Media: On a Roll and More to Come

It's a busy time at Atlantic Media. Among President Justin Smith's initiatives are new iPad apps for The Atlantic magazine and a paid version for all Atlantic content. Plus, a total overhaul of National Journal. They're all possible because The Atlantic is set to be profitable again.

Deutsche Bank Initiates Coverage of Biotech Stocks

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

Health Care Stocks: Winners and Losers

As hyperactive and reactive as markets can be, sometimes they get it right. Witness Monday's relief rally after the House voted to overhaul health insurance. The major averages enjoyed vigorous gains, led for much of the session by, yes, the health care sector.

Amgen's New Bone Drug Passes a Crucial Test

Much of the biotech's future rests on the experimental bone drug denosumab, to be sold commercially as Prolia. The drug has had its ups and downs, but Amgen says a pivotal Phase 3 clinical trial pitting denosumab against Novartis's Zometa showed that denosumab worked better.

Marketing Fines: A Cost of Business for Pharma?

The FDA has nearly doubled the warning letters it's sent to drugmakers for questionable promotion in the past year. But some critics say the fines don't go far enough, and that Big Pharma merely views the penalties as the price of doing business.

2010 Could Be Big for Small Biotechs

Biotech stocks surprised in 2009 by surging. Equally surprising was the robust performance of the young and small-cap crowd of mostly development-stage companies, which trumped their large-cap brethren. That pattern could prevail again this year.

Amgen Misses Street's Expectations

Amgen, the world's largest biotechnology company, reported fourth-quarter results that missed Wall Street's expectations, as a 2% increase in sales failed to translate into a stronger bottom line.