Pharmaceuticals

Affymax, Takeda Recall Anemia Drug Omontys After Deaths

U.S.-based Affymax Inc and Japan's Takeda Pharmaceutical Co said they are voluntarily recalling all lots of anemia treatment Omontys (peginesatide) in the United States due to reports of serious hypersensitivity reactions, including some deaths.

Male Enhancement Pills Recalled ... for Working a Bit Too Well

Super Power, an "all-natural herbal extract" promises enhanced libido and more to the men who take it. But the supplement's manufacturer, Freedom Trading, made sure its pills could deliver male performance by adding a secret ingredient that crossed the line.

Big Pharma Ads Flaunt FDA Rules

Officially, it's the FDA's job to ensure that pharmaceutical ads adhere to guidelines. But the agency's annual compliance budget is $9 million, while drug companies spend $58 billion a year on marketing. So it comes as no surprise that only 18% of ads are in compliance with the rules. But it's still disturbing: This is your health.

How Safe Are the Drugs in Your Medicine Cabinet?

Do you want your new prescription drugs to be made under last century's oversight? Like it or not, that's likely what you're getting -- or worse -- because increasingly, Americans' medicines are made overseas in place where the oversight isn't up to U.S. standards.

Pfizer Sells Capsugel: Will More Asset Sales Follow?

On Monday, Pfizer announced it would sell its Capsugel business to private-equity firm KKR for $2.375 billion. If the hints the drugmaker has been giving lately are true, the move could be the start of two years of major asset sales. Here's what's ahead for the world's biggest pharmaceutical company.

Swine Flu Response Wasn't Influenced by Vaccine Makers

During the H1N1 swine flu pandemic, much criticism was leveled at World Health Organization officials, accusing their response of being too heavily influenced by the pharmaceutical industry. But according to a panel of independent experts, that wasn't the case.

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.

Pfizer Shrinks Its Drug Pipeline Amid R&D Cuts

In an update Tuesday, Pfizer said it is discontinuing 15 of the projects in its development pipeline. The news comes a month after the world's largest pharmaceutical company announced large research and development cuts were on the way.

Top-Selling Drugs About to Lose Patent Protection

The pharmaceutical industry is ready to fall off a cliff -- a "patent cliff." Over the next few years, some of the world's most popular and lucrative medicines will go off patent, and generic competition will siphon an estimated quarter of a trillion dollars from drugmakers' bottom lines.

New Cystic Fibrosis Drug Treats the Disease's Cause

Vertex Pharmaceutical shares soared 15% Wednesday as Wall Street cheered the results of a late-stage study of its new cystic fibrosis drug, an experimental treatment that targets the underlying cause of the disease rather than just its symptoms.

Big Pharma Looks Beyond Drugs to Smartphone Apps

Pharmaceutical companies looking for fresh sources of profit are increasingly investing in a range of health care innovations that aren't drugs at all, from smartphone apps and educational websites to social media platforms and wireless devices, reports Ernst & Young.

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.

Sanofi-Aventis, Genzyme on the Brink of a Merger

It seems that months of merger talks between French pharma Sanofi-Aventis and U.S. biotech Genzyme have entered the home stretch. This week, Sanofi is expected to offer $74 a share for Genzyme, with an option included potentially worth $5 to $6 a share.

More Proof That Whistleblowing on Medicaid Fraud Works

Whistleblowing firm Ven-A-Care has recovered $2 billion for taxpayers by suing drug companies that overcharge the government and create windfalls for participating pharmacies. It also has made $380 million for itself. What's the problem with that?

Pfizer Joins Other Pharmas in Giving a Cautious Outlook

Pfizer reported fourth-quarter earnings on Tuesday that nearly quadrupled from a year ago as revenue rose 6%. But it also lowered its sales guidance for 2012, due to some of its bestselling drugs going off patent. What's ahead for the world's biggest drugmaker:

Another Cancer-Drug Failure Highlights Difficulties Facing Pharmas

Sanofi-Aventis announced its cancer drug candidate iniparib failed in a late-stage clinical trial. Other pharmaceutical companies have also experienced recent setbacks as they scramble to bolster their pipelines ahead of the patent cliff, when they will be forced to compete with cheaper generics.

As Diabetes Explodes, Big Pharma Is Gearing Up

Diabetes is a growing global scourge, but for Big Pharma it's more of a lifesaver -- and many drugmakers are cranking up their research efforts. After all, many existing drugs will soon be losing their patents, and diabetes could be a $55 billion market by 2019.

Government Recoups $4 Billion from Health Care Fraud Cases

The government recouped a staggering $4 billion in fiscal 2010 that was stolen from federal health care programs, the departments of Justice and Health and Human Services announced Monday -- the highest annual amount ever. More than half of the fraud money recovered came from drug companies.

Glaxo Faces First of Many Possible Avandia Trials

Did GlaxoSmithKline's blockbuster diabetes drug Avandia cause fatal heart attacks? The first federal trial of an Avandia lawsuit began this morning in Philidelphia. As many as 50,000 more lurk in the wings.

What Pfizer Sees in Lpath's Innovative Blindness Drugs

Lpath focuses on developing therapeutics that target bioactive lipids for treating a range of human diseases, including cancer and diseases that cause blindness. Its promising drugs have attracted attention -- and lots of money -- from Pfizer. More of both could be coming.

A Depressing Outlook for Big Pharma's Next Few Years

After several years of robust expansion, the leading branded pharma companies will see growth slow to just 1.3% from now to 2015, independent market analyst company Datamonitor said in a new report. The primary culprit: expiring patents and an onslaught of generic competition.