Archive for March, 2009

Brain Trust or Brain Drain?

Erik Greb PharmTech editorHow do you boost a flagging pipeline? One strategy is to enlist more researchers to find promising drug candidates. Two heads are better than one, and the more minds applied to the task, the more likely they will find increasingly elusive new therapies. The Pfizer–Wyeth and Merck–Schering Plough mergers are partly based on this premise.

Trouble is, the premise might not hold water. Read more »

Obama’s Choice of Hamburg to Lead FDA: Good or Bad?

Patricia Van Arnum PharmTech editor Press reports say that President Barack Obama intends to nominate Margaret A. Hamburg, a former New York City health commissioner, to lead Food and Drug Administration, according to the New York Times, Wall Street Journal, and Time. Joshua Sharfstein, the health commissioner of Baltimore, is expected to be chosen as deputy director. What do these choices mean for the pharmaceutical industry? Read more »

Roche and Genentech Finally Decide on $46.8 Billion Deal

Alexis Brekke Pellek PharmTech editorEnding nearly eight months of negotiations, Roche and Genentech agreed yesterday on a price of $95 per share in cash (approximately $46.8 billion) for Roche to acquire the 44% of Genentech it doesn’t already own. Read more »

Restrategizing Is No Longer an Option

Angie Drakulich PharmTech editorSo far, the first quarter of 2009 has been full of initiatives that call for, if not push for, change in the pharmaceutical industry and in medical science overall. Some may say it started when Obama took office. Within six weeks of leading the country, he announced $1.1 billion for comparative effectiveness research. Then, his proposed FY 2010 budget included support for a regulatory pathway for follow-on biologics. And this week, he reversed the ban on the use of federal funding for stem-cell research.

Read more »

Virus Changes Pose New Difficulties

Maribel Rios PharmTech editorIt is inspiring to read news about the advancements being made in the fight against viral infections, including those against influenza and HIV. However, as comments to recent blog posts have reminded me, the struggle to develop antiviral therapies is highly complicated because viruses have the infamous tendency to mutate and adapt in their fight for survival and conquest of healthy cells. A major part of formulating and developing antivirals is trying to get some handle on a virus’s unpredictable nature, how it will change, and how these modified forms will strengthen our understanding of its interworkings. Read more »

The Other New Jersey Giants

Erik Greb PharmTech editorIt’s déjà vu all over again. Little more than a month after Pfizer (New York) announced that it would acquire Wyeth (Madison, NJ), Merck (Whitehouse Station, NJ) and Schering-Plough (Kenilworth, NJ) have unveiled their own merger agreement. The combined company will be called Merck and be based in Whitehouse Station, New Jersey. Schering-Plough CEO Fred Hassan will help during the merger, but Merck’s CEO Richard Clark will lead the combined company. Read more »

Drug Fact Boxes: A Good Move or Overregulation?

Patricia Van Arnum PharmTech editor A recent article in the New York Times describes the results of a study by Steven Woloshin and Lisa Schwartz, two researchers from the Dartmouth Institute for Health Policy and Clinical Practice, which showed that a drug-fact box improved US consumers’ knowledge of prescription drugs’ benefits and side effects. The researchers presented their findings at a recent meeting of a FDA Risk Communication Advisory Committee, urging the committee to adopt a drug-fact-box labeling system (similar to nutrition-fact panels on food packaging), which would be used in print prescription drug advertisements to quantify the benefits and risks of taking a drug. Read more »

Comparative Effectiveness May Have Influenced Pfizer Already

Angie Drakulich PharmTech editorPfizer announced last week that it was terminating its Phase 3 development programs for the investigational compounds esreboxetine, meant to treat fibromyalgia, and PD 332,334, targeted to treat generalized anxiety disorder.

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To Lead, You Need Followers

Erik Greb PharmTech editorThe wait may soon be over for US Food and Drug Administration employees wondering who their new boss will be. President Obama is expected to introduce Governor Kathleen Sebelius of Kansas today as his new nominee for secretary of the US Department of Health and Human Services. Read more »

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