Author Archive

Tax Breaks for Big Pharma: A Remedy for Unemployment?

Erik Greb PharmTech editorWorried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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Better Quality Could Mean Fewer Drug Shortages

Erik Greb PharmTech editor

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

What Patients Don’t Know Could Hurt Drugmakers

Erik Greb PharmTech editor

A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

Could Wild Gudgeon Be Canaries in a Coal Mine?

Erik Greb PharmTech editor

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

A Call for Clarity about Vaccines

Erik Greb PharmTech editorAs I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

Bright Future, Big Molecules

Erik Greb PharmTech editor

The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

Meet the New Drugs: Same as the Old Drugs

Erik Greb PharmTech editorStock prices have fluctuated wildly in response to factors such as persistently high unemployment, impending cuts in federal spending, and the downgrade of America’s credit rating. The already conservative pharmaceutical industry is hunkering down and socking away cash to be safe. Since January, Merck has saved $1 billion in cash, and Johnson & Johnson has saved $3 billion. The savings have come at the expense of R&D budgets, making observers wonder where the new drugs will come from.

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QbD in Theory and Practice

Erik Greb PharmTech editorThe pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

FDA Follows EMA toward Follow-On Biologics

Erik Greb PharmTech editorDuring this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Georgia Researchers Develop Multicompartment Gel Capsules

Erik Greb PharmTech editorA dosage form that delivers several drugs, either at once or in succession, can have many benefits for patients. The administered drugs could have synergistic effects when delivered together, and the convenient dosage form could improve patient compliance. And, of course, reformulating several drugs for codelivery could help breathe new life into a company’s patents. All of these advantages came to mind when I learned about a multiple-compartment gel capsule developed at the Georgia Institute of Technology. Read more »

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