/home/corante/public_html/pipeline/ en-us derekb.lowe@gmail.com 2013-05-02T11:18:39-05:00 hourly 1 2000-01-01T12:00+00:00 http://pipeline.corante.com/archives/2013/05/02/aveo_gets_bad_news_on_tivozanib.php The kinase inhibitor tivozanib (for renal cell carcinoma) was shot down this morning at an FDA committee hearing. There are going to be a lot of arguments about this decision, because feelings have been running high on both sides of... 76386@/home/corante/public_html/pipeline/ Cancer 2013-05-02T11:18:39-05:00 http://pipeline.corante.com/archives/2013/03/27/the_nih_pfizer_and_senator_wyden.php Senator Ron Wyden (D-Oregon) seems to be the latest champion of the "NIH discovers drugs and Pharma rips them off" viewpoint. Here's a post from John LaMattina on Wyden's recent letter to Francis Collins. The proximate cause of all this... 76306@/home/corante/public_html/pipeline/ Academia (vs. Industry) 2013-03-27T06:50:28-05:00 http://pipeline.corante.com/archives/2013/03/25/the_fdas_new_alzheimers_guidance_wonder_or_blunder.php You can get either answer, depending on whom you ask. Last month, the agency unveiled new guidelines for developing Alzheimer's therapies. They're trying to deal with the difficulty of showing actual cognitive improvement in more advanced patients, while at the... 76302@/home/corante/public_html/pipeline/ Alzheimer's Disease 2013-03-25T10:51:25-05:00 http://pipeline.corante.com/archives/2013/03/11/suing_a_generic_drug_maker_when_and_how.php The great majority of prescriptions in this country are for generic drugs. And generic drugs are cheaper in the US than they are in Europe or many other areas - they're a large and important part of health care. And... 76268@/home/corante/public_html/pipeline/ Regulatory Affairs 2013-03-11T07:02:00-05:00 http://pipeline.corante.com/archives/2013/03/04/von_eschenbach_takes_another_whack_at_phase_iii_trials.php Here's a new editorial on clinical trials and drug development by Tomas Philipson and Andy von Eschenbach (former head of the FDA). It continues his earlier theme of scaling back Phase III trials (which I commented on here). These Phase... 76250@/home/corante/public_html/pipeline/ Clinical Trials 2013-03-04T08:06:48-05:00 http://pipeline.corante.com/archives/2013/02/11/2012s_new_drugs.php Thanks to Lisa Jarvis at C&E News, here's a chart (PDF) of the 39 drugs approved last year by the FDA. Last year was a good year, by almost any measure. The question as we go on will be whether... 76205@/home/corante/public_html/pipeline/ Regulatory Affairs 2013-02-11T13:05:43-05:00 http://pipeline.corante.com/archives/2013/02/11/phrma_and_why_people_dislike_the_drug_industry.php John LaMattina takes off after PhRMA's effectiveness here at Forbes. His two points are release of clinical trial data and openness about consultant payments to physicians. And I agree with him on both of those - as I've said here... 76204@/home/corante/public_html/pipeline/ Regulatory Affairs 2013-02-11T09:19:40-05:00 http://pipeline.corante.com/archives/2013/02/07/ducts_down_with_useless_clinical_trial_acronyms.php I'm not the first person to complain about these things, of course. Even by 2003, there were sixteen different clinical trials in the literature with the acronym HEART. It appears that the cardiovascular field picked up the acronym bug early,... 76196@/home/corante/public_html/pipeline/ Clinical Trials 2013-02-07T08:15:20-05:00 http://pipeline.corante.com/archives/2012/12/11/free_to_promote_offlabel_not_so_fast_.php Steve Usdin at BioCentury has a very interesting article (free access) following up on that surprise decision that the FDA's restrictions on off-label promotion are a violation of the First Amendment: But companies and individuals who take the decision as... 76062@/home/corante/public_html/pipeline/ Regulatory Affairs 2012-12-11T11:22:37-05:00 http://pipeline.corante.com/archives/2012/12/05/offlabel_promotion_is_legal_you_say.php You'll have seen the headlines about off-label promotion of drugs by pharma companies. No, not the ones that decry it as a shady marketing technique, punishable by huge fines. I mean the ones about how a federal court has ruled... 76046@/home/corante/public_html/pipeline/ Business and Markets 2012-12-05T07:12:44-05:00 http://pipeline.corante.com/archives/2012/11/14/budgets_and_revenues.php Note: politics ahead. This will not be a regular feature around here, but when events warrant, it'll rear its scaly head. BioCentury has an interesting piece this week on the growing budget impasse and its implications for both academic and... 75996@/home/corante/public_html/pipeline/ Regulatory Affairs 2012-11-14T08:27:19-05:00 http://pipeline.corante.com/archives/2012/10/31/the_coming_battle_over_alzheimers_disease.php Solanezumab is a story that won't go away. Eli Lilly's antibody therapy for Alzheimer's is the subject of a lot of arguing among investors: some people (and I'm one of them) think that there is no strong evidence for its... 75973@/home/corante/public_html/pipeline/ Alzheimer's Disease 2012-10-31T06:57:47-05:00 http://pipeline.corante.com/archives/2012/10/26/basically_theyre_a_bunch_of_lemmings.php True, but that's unfair to lemmings. This is Raghuram Selveraju of Aegis Capital, talking about deal-making executives in the big pharma companies and the string of costly blowups so far this year. That link has the list, and it's quite... 75965@/home/corante/public_html/pipeline/ Business and Markets 2012-10-26T06:53:07-05:00 http://pipeline.corante.com/archives/2012/10/18/the_generic_wellbutrin_problem_whose_fault_is_it.php One of the questions I get asked most often, by people outside of the drug industry, is whether generic medications really are the same as the original branded ones. My answer has always been the same: that yes, they are.... 75941@/home/corante/public_html/pipeline/ Regulatory Affairs 2012-10-18T06:29:53-05:00 http://pipeline.corante.com/archives/2012/09/06/accelerated_approval_and_its_discontents.php This may sound a little odd coming from someone in the drug industry, but I have a lot of sympathy for the FDA. I'm not saying that I always agree with them, or that I think that they're doing exactly... 75849@/home/corante/public_html/pipeline/ Regulatory Affairs 2012-09-06T07:07:01-05:00