An estimated one thousand clinical trials have been conducted for gene therapies in the past 20 years, but to date, not a single drug has made it to FDA approval. However, we may be a step closer as Introgen today announced that it has filed applications with FDA and EMEA for marketing approval of Advexin, […]

[Read more →]

Just back from BIO, where two of the most interesting conversations I had were with companies from Down Under.
First was Paul Tan, CEO of Living Cell Technologies, which is officially headquartered in Melbourne Australia, but operates out of Auckland, New Zealand. The company is developing a diabetes therapy that involves implanting specially encapsulated pig pancreas […]

[Read more →]

Last week’s congressional hearings on direct-to-consumer advertising were, as expected, pretty inconclusive—but that doesn’t mean we won’t be hearing a lot more on the topic. The big question, I think, is when (and whether) the debate will ever get to the point of realism about what DTC is and can be. The idea of advertising […]

[Read more →]

The last time Pharm Exec covered Valeant Pharmaceuticals, it was in 2005, and things were looking good for the company. It had a new name, and a sleek new organization, lighter than the old by 8,000 employees. New CEO Timothy Tyson had created a talented and enthusiastic new management team. A new strategy was in […]

[Read more →]

If, in the wake of the sale of Millennium, you’ve been wondering what ever happened to the company’s co-founder and longtime CEO Mark Levin, the answer was in this morning’s deal news, in the announcement that a young biotech called Constellation Pharmaceuticals had closed a $32 million Series A financing. The companies coming up with […]

[Read more →]

I had a chance late last week to moderate a panel at the Healthcare Dealmaking Symposium, sponsored by our friends at The Deal. My panelists, Annarie Lyles, SVP and Head of Corporate Development for Genmab, and Robert Knowles, Senior Director of Worldwide Business Development for Pfizer, had some very interesting insights into the state of […]

[Read more →]

The Supreme Court last Wednesday decided the first of an important series of cases having to do with whether FDA approval and regulation preempts lawsuits at the state level. The case was Riegel v. Medtronic, and it had to do with a balloon catheter that burst during an angioplasty. Though it’s a device case, not […]

[Read more →]

“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules […]

[Read more →]

We read a lot of critiques of the pharma industry, and frankly many of them leave a lot to be desired in terms of logic, clarity, and thoughtfulness.
For an example of the opposite—a truly clear and scorching attack, let us recommend to you a document prepared by Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry […]

[Read more →]

Don’t miss the current issue of Fast Company magazine, which features a look at a fascinating new program at Pfizer. It seems that in the wake of the company’s deep layoffs, Jordan Cohen, senior director of organizational effectiveness, started looking at what executives were doing and discovered that lots of it consisted of menial tasks—researching, […]

[Read more →]