Avandia’s Reckoning Day

After years of debate over the safety of GlaxoSmithKline’s diabetes drug Avandia, U.S. and European regulatory agencies have finally made a decision about the future of the drug. European authorities have recommended suspending marketing of the drug, while FDA is severely restricting access to the drug, but seems to be leaving the door open to further actions. GSK, meanwhile, issued a press release saying it would stop promoting...

Read More

Blood Thinner Marketing, Soap Opera-Style

Let’s say your blood thinner got a unanimous thumbs-up from an FDA panel. And now, in anticipation of the drug’s possible approval, you’d like to raise awareness about atrial fibrillation, one of the conditions your drug candidate will treat. Why not send out some well-respected cardiologists or researchers to spread the word to the people? Not sexy enough, you say? OK, then, how about a soap opera star? Yes, this...

Read More
Boehringer’s Blood Thinner Dabigatran (Pradaxa) Unanimously Endorsed
Sep22

Boehringer’s Blood Thinner Dabigatran (Pradaxa) Unanimously Endorsed

After last week’s Meridia and Lorqess drama, I could’ve really used some good news from an FDA panel. And on Monday, I got it- in the form of a unanimous endorsement for a new blood thinner. The drug getting the love is dabigatran etexilate, which was developed by family-owned Boehringer Ingelheim and will be marketed as Pradaxa if approved. It’s one of a cadre of drugs trying to replace warfarin (also known as...

Read More
Genetic Tests And Rimonabant: Coulda, Woulda, Shoulda
Aug18

Genetic Tests And Rimonabant: Coulda, Woulda, Shoulda

Here’s something I missed while finishing up that blood thinner cover story. Last week Reuters reported that genetic testing might have helped save rimonabant, the ill-fated obesity medication once touted as a future blockbuster. Rimonabant, which blocks the cannabinoid-1 receptor, the target of marijuana’s psychoactive ingredient, appeared to help people lose weight. But it also increased the risk of psychiatric side...

Read More
On Blood Thinners And Rat Poison
Aug16

On Blood Thinners And Rat Poison

C&EN’s cover story this week is about finding replacements for the blood thinner warfarin, something that hasn’t happened in the more than fifty years since the drug went on the market. Warfarin prevents blood clots from forming and reduces active clots as well. When it works, it’s great for preventing strokes. As a bonus, it’s a dirt cheap pill, costing on the order of a couple of cents a day. But the...

Read More

Strong Panel Backing For AstraZeneca Blood Thinner Brilinta

The blood-thinning drug club is one step closer to getting a new member. Today, an FDA advisory panel gave a thumbs-up recommendation to Brilinta (ticagrelor), an experimental blood thinner from AstraZeneca. The vote was 7-1 in favor of approval, an enthusiastic endorsement that increases the chances that FDA will decide to approve the drug. The FDA is supposed to make its call on Brilinta by Sept. 16. Brilinta is in the same drug...

Read More