/home/corante/public_html/pipeline/ en-us derekb.lowe@gmail.com 2012-01-05T11:18:28-05:00 hourly 1 2000-01-01T12:00+00:00 http://pipeline.corante.com/archives/2012/01/05/reaction_to_andy_groves_clinical_trial_proposals.php I should mention that Science is publishing some letters that it received in response to Andy Grove's proposal to rework the clinical trial system for drug development. Sidney Wolfe and Michael Carome of Public Citizen aren't too happy with the... 75366@/home/corante/public_html/pipeline/ Clinical Trials 2012-01-05T11:18:28-05:00 http://pipeline.corante.com/archives/2011/12/05/rexahn_rides_again.php You may remember Rexahn Pharmaceuticals being mentioned here in 2010. They're the company whose lead antidepressant drug Serdaxin showed no significance versus placebo in Phase IIa trials, and whose CEO (Dr. Ahn himself) then calmed the investment community by saying... 75309@/home/corante/public_html/pipeline/ The Central Nervous System 2011-12-05T07:31:21-05:00 http://pipeline.corante.com/archives/2011/11/08/targacepts_antidepressant_fails_and_how.php Bad news yesterday from Targacept, a small company that's been developing an antidepressant with AstraZeneca. TC-5214 (the S enantiomer of the nicotinic ligand mecamylamine) missed its endpoints in a trial of 295 patients in Europe who had not responded to... 75264@/home/corante/public_html/pipeline/ The Central Nervous System 2011-11-08T08:28:37-05:00 http://pipeline.corante.com/archives/2011/11/03/medivation_comes_through_with_mdv3100.php Remember Medivation? That's the small biotech that was trying to develop a Russian compound as an Alzheimer's drug, an effort which blew up completely in early 2010. The company did have one other compound in development, targeting prostate cancer, a... 75257@/home/corante/public_html/pipeline/ Cancer 2011-11-03T07:08:19-05:00 http://pipeline.corante.com/archives/2011/11/01/exelixis_fights_city_hall_and_city_hall_looks_like_winning.php So what happens when you and the FDA disagree on the clinical trials needed to show efficacy for your new drug? Well, this happens: your stock opens down 40%. That's what's going on with Exelixis today - here are the... 75251@/home/corante/public_html/pipeline/ Business and Markets 2011-11-01T09:20:26-05:00 http://pipeline.corante.com/archives/2011/10/11/too_many_cancer_drugs_too_few_about_right.php According to Bruce Booth (@LifeSciVC on Twitter), Ernst & Young have estimated the proportion of drugs in the clinic in the US that are targeting cancer. Anyone want to pause for a moment to make a mental estimate of their... 75217@/home/corante/public_html/pipeline/ Cancer 2011-10-11T08:01:51-05:00 http://pipeline.corante.com/archives/2011/09/28/andy_groves_idea_for_opening_up_clinical_trials.php The last time I talked here at length about Andy Grove, ex-Intel CEO, I was rather hard on him, not that I imagine that I ruined his afternoon much. And in the same vein, I recently gave his name to... 75198@/home/corante/public_html/pipeline/ Clinical Trials 2011-09-28T07:29:12-05:00 http://pipeline.corante.com/archives/2011/08/05/bernard_munos_rides_again.php I've been meaning to link to Matthew Herper's piece on Bernard Munos and his ideas on what's wrong with the drug business. Readers will recall several long discussions here about Munos and his published thoughts (Parts one, two, three and... 75116@/home/corante/public_html/pipeline/ Business and Markets 2011-08-05T09:19:36-05:00 http://pipeline.corante.com/archives/2011/08/01/laquinimod_fails_for_multiple_sclerosis.php If you haven't been reading carefully, you might have had trouble figuring out Teva's oral therapy for multiple sclerosis, laquinimod. After all, earlier this year, the company was blowing the horn for the compound at neurology meetings, touting how safe... 75106@/home/corante/public_html/pipeline/ The Central Nervous System 2011-08-01T11:57:35-05:00 http://pipeline.corante.com/archives/2011/07/08/the_duke_cancer_scandal_and_personalized_medicine.php Here's a good overview from the New York Times of the Duke scandal. Basically, a team there spent several years publishing high-profile papers, and getting high-profile funding, and treating cancer patients based on their own tumor-profiling biomarker work. Which was... 75081@/home/corante/public_html/pipeline/ Cancer 2011-07-08T08:29:48-05:00 http://pipeline.corante.com/archives/2011/06/30/an_unethical_clinical_trial.php Well, here's one from the Archives of Internal Medicine that most certainly did get published. It's an analysis of an old clinical trial, STEPS, which was conducted for Neurontin (gabapentin) during the 1990s. But that's not quite right. The authors... 75073@/home/corante/public_html/pipeline/ The Dark Side 2011-06-30T10:09:49-05:00 http://pipeline.corante.com/archives/2011/06/27/making_the_numbers_confess.php Adam Feuerstein calls this not just "post hoc data mining", but "extreme post hoc data mining". Take a look and see what you think. Update: more here.... 75066@/home/corante/public_html/pipeline/ Clinical Trials 2011-06-27T11:20:14-05:00 http://pipeline.corante.com/archives/2011/05/27/niacins_unexpected_flop.php Let's add to the uncertainty about whether we understand cardiovascular disease, OK? The NIH has been conducting a large statin-plus-niacin trial, which is definitely a combination worth looking at. The statin will lower your LDL, and niacin will raise your... 75018@/home/corante/public_html/pipeline/ Cardiovascular Disease 2011-05-27T11:01:22-05:00 http://pipeline.corante.com/archives/2011/05/27/the_ethics_of_avastin.php When we last spoke about the Avastin-and-breast-cancer story here, the FDA had rescinded its provisional approval for that indication, and a number of people were shouting that here it was, health care rationing based on price, right in front of... 75017@/home/corante/public_html/pipeline/ Cancer 2011-05-27T07:17:52-05:00 http://pipeline.corante.com/archives/2011/05/18/fenofibrate_good_for_much.php Abbott has some difficult times ahead with their fenofibrate franchise. That's TriCor, and its newer formulation, TriLipix. Fenofibrate, as I've mentioned here before, is an oddity among drugs. It was discovered way before anyone had a mechanism of action, and... 75002@/home/corante/public_html/pipeline/ Cardiovascular Disease 2011-05-18T12:37:00-05:00