http://www.qdinformation.com/qdisblog A blog about chemistry, drug development, science, and technology Sun, 11 May 2008 23:50:40 +0000 http://backend.userland.com/rss092 en Wow! I read today that the EU performed raids on almost all the major drug companies on Wednesday. This includes Pfizer, Sanofi-Aventis, GlaxoSmithhKline, Astrazeneca, Merck, and Johnson & Johnson.E.U. raids drug companies in broad inquiryThe authorities are looking for evidence of abuse of patents and illegal deals to ... http://www.qdinformation.com/qdisblog/2008/01/17/eu-raids-major-drug-companies/ As you may have noticed I've had some time to get caught up on programs I tivo'ed. Another program I really enjoyed was Nova's "Absolute Zero: The Conquest of Cold" which you can watch online for free.I've always been a big fan of Nova and it is on my ... http://www.qdinformation.com/qdisblog/2008/01/15/nova-episode-conquest-of-cold/ I Tivo'ed Frontline's "The Medicated Child" recently and finally got around to watching it the other night. This is a follow up from an episode they did on this back in 2001. You can watch and read about it online. It was somewhat disturbing at parts especially ... http://www.qdinformation.com/qdisblog/2008/01/15/pbs-frontline-the-medicated-child/ The subject of pharma spending on R&D versus Marketing is one that comes up frequently. Recently FierceBiotech has had an article on this.Drug industry spends nearly twice as much on marketing than on research and development - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News:Here is the ... http://www.qdinformation.com/qdisblog/2008/01/15/spending-on-marketing-vs-rd/ This is the kind of stuff that gives the pharma industry a bad name. I've long had a problem with some of those on the marketing side who see Congress questions Jarvik's Lipitor lip service, credentials as part of celebrity-pitch probe - International Herald Tribune:I think the pharma industry ... http://www.qdinformation.com/qdisblog/2008/01/10/dr-jarvik-lipitor-and-ethics/ Here are a couple of good blog postings about the low number of drug approvals in 2007.The IN VIVO Blog: Another Dismal Year for New Drug Approvals:Where have all the new drug's gone: Industry's medicine cabinet running empty on compounds- NJ.comWith only 18 approvals it is the lowest since 1983 ... http://www.qdinformation.com/qdisblog/2008/01/10/drug-approvals-in-2007/ Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of ... http://www.qdinformation.com/qdisblog/2008/01/02/pharmalive-pfizer-receives-approvable-letter-from-fda-for-dalbavancin/ It will be interesting to see how things develop with regards to new drug approvals and the FDA in 2008. My guess is that for new drugs for which treatment already exists that the FDA will continue to demand evidence of not only of safety and effectiveness but also that is ... http://www.qdinformation.com/qdisblog/2008/01/02/the-fda-and-2008/ Here are a few of the important articles from the last couple of weeks.Glaxo set to axe staff as crisis hits drug - Telegraph Generic Biotech Drugs Won't Be in U.S. Legislation Bloomberg.com: News The Scientist : New patent rules hurt biotech? Chemical & Engineering News: Government & Policy - Patent Reform ... http://www.qdinformation.com/qdisblog/2007/10/04/review-of-important-items-from-sept-17-30/ Looks like PDL Biophrma after going through some tough times and laying-off people is finally up for sale. Here are just some of the articles recently.PDL to lay off 250, sell four drugs, shift focus - San Francisco Business Times PDL BioPharma up for sale - Examiner.com San Jose Mercury News ... http://www.qdinformation.com/qdisblog/2007/10/03/pdl-up-for-sale/ I must apologize for not posting more but I have been extremely busy with work and have some personal family issues to deal with. I'm hoping to get back into regularly posting on a daily basis later this month but for the next two weeks it will be hit ... http://www.qdinformation.com/qdisblog/2007/10/03/reasons-for-not-postings-recently/ Forbes recently had an article on fighting the FDA.You Can't Fight The FDA - Forbes.comI have been watching this drama play out for sometime now and for me it is like watching a train wreck. You know what's going to happen, you know it isn't going to be pretty ... http://www.qdinformation.com/qdisblog/2007/09/08/encysive-the-fda-and-the-dispute-resolution-process/ Reuters is reporting that the new FDA legislation is unlikely to have any biogenerics in it.UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress ... http://www.qdinformation.com/qdisblog/2007/09/07/no-generic-biologics-in-fda-legislation/ I'm not going to comment on these other than to say the merger mania continues. Here are some recent headlines. PharmaLive: Shareholders Approve Peptech-EvoGenix Merger : PharmaLive: Ametek Acquires Cameca SAS PharmaLive: GeoPharma Announces Shareholder Approval of Merger with Dynamic Health Products Meda AB to Buy MedPointe Pharmaceuticals for $800 Million in Cash, ... http://www.qdinformation.com/qdisblog/2007/09/07/more-on-mergers/ This is a somewhat unusual post. I have now made available an application I had someone develop for me that takes an enhanced podcast (AAC) with a m4a or m4b extension and takes the chapter names, URLs and time code from the file and exports that into html for ... http://www.qdinformation.com/qdisblog/2007/08/25/podchapter-exporter-now-available/ Amgen is now cutting jobs too and there have been several articles regarding this.Amgen cutting costs as key anemia drug sales fall: Financial News - Yahoo! Finance Hometown feeling Amgen's pain - Los Angeles Times Amgen to Cut Up to 2,600 Jobs - washingtonpost.com Amgen slows its Bay Area expansion - San Francisco Business ... http://www.qdinformation.com/qdisblog/2007/08/20/amgen-cutting-costs-as-key-anemia-drug-sales-fall/ I've been talking about this for a while and there is finally an AP story outlining all the big pharma job cuts. Drug Industry Sees Big Job Cuts: Financial News - Yahoo! Finance Here is a summary: Johnson and Johnson 4,800 Pfizer 10,000 Merck 7,000 AstraZeneca 7,600 Schering-Plough 1,100 Bristol-Myers Squibb unspecified ... http://www.qdinformation.com/qdisblog/2007/08/06/major-job-cuts-in-big-pharma/ There seems to be another round of lay-offs downsizing or whatever else they are calling it now in the pharmaceutical industry. Johnson & Johnson Plans to Cut 4,800 Jobs - New York Times J&J restructuring to cut up to 4,820 jobs Alza to cut 600 jobs, exit Mountain View HQ: Financial News ... http://www.qdinformation.com/qdisblog/2007/08/03/big-pharma-job-cuts/ I'm trying to get caught up on a lot of stuff since taking a few days of to visit family and friends. Here are some of the stories recently regarding mergers & acquisitions as well as deals.PharmaLive: SurModics Acquires Brookwood Pharmaceuticals Surmodics is a drug delivery company and Brookwood ... http://www.qdinformation.com/qdisblog/2007/08/03/mergers-acquisitions-and-deals/ I came across this article recently and found it thought provoking. Seems many drug industry critics are taking to YouTube to get their message out.Big Pharma on YouTube - not a pretty picture | Trusted.MD Network:The main video talked about in the article is one from a former Lilly ... http://www.qdinformation.com/qdisblog/2007/07/25/big-pharma-and-youtube/ Encysive has brought in Morgan Stanley to evaluate options. Let me translate that. They are going to be up for sale but they need to slash expenditures to make them look better. Morgan Stanley to help Encysive evaluate options - Houston Business Journal Here's the interesting quote from this article. Encysive ... http://www.qdinformation.com/qdisblog/2007/07/19/encysive-to-evaluate-options/ Encysive may have set a new record for the number of approvable letters for one single product. Recently the FDA gave them their THIRD approvable letter for the product Thelin (sitaxsentan sodium)Press Release: FDA Issues Third Approvable Letter for Thelin - FierceBiotech:TheStreet.com has an insightful article on this.How Encysive ... http://www.qdinformation.com/qdisblog/2007/07/09/fda-issues-third-approvable-letter-to-encysive-for-thelin/ Allos had a disappointing failure in phase III for efaproxyn for treatment of brain cancer that originated from breast cancer.Allos' Brain Cancer Drug Flops in Phase 3 - Health - RedOrbit:In typical upbeat company fashion, they said they were disappointed but immediately started proclaiming their pipeline and how promising it ... http://www.qdinformation.com/qdisblog/2007/07/09/allos-brain-cancer-drug-fails-phase-3-trials/ Novartis has done a deal with Intercell an Austrian company for access to one of their vaccines. It is for IC31 against influenza.Chemical & Engineering News: Latest News - Novartis expands its vaccines portfolio through a sweeping $366 million deal with Intercell:Novartis actually has an article on this on their ... http://www.qdinformation.com/qdisblog/2007/07/09/novartis-in-a-deal-with-intercell-for-366-million/ Faced with an advisory panel that unanimously had safety concerns, Sanofi has decided to withdrawal their NDA for Accomplia (rimonabant).Sanofi Withdraws Obesity Pill From FDA - Forbes.com:Sanofi stated they had plans to resubmit the NDA at "a later date". It should also be noted that Sanofi plans to use ... http://www.qdinformation.com/qdisblog/2007/07/06/sanofi-withdraws-obesity-pill-from-fda-consideration/ Amgen is the latest to get into the merger mania and has offerd $420 million for Ilypsa. Amgen to pay $420 mln cash for Ilypsa - MarketWatch Amgen wants access to Ilypsa'a ILY101 a drug for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on hemodialysis. Here is the press ... http://www.qdinformation.com/qdisblog/2007/06/25/amgen-to-purchase-ilypsa-for-420-mln/ Amgen has another merger in process, now with Alantos for $300 million.RED HERRING | Amgen to Acquire Alantos:Now they also are purchasing Ilpysa which I posted about recently. Altantos has a phase II drug for diabetes a somewhat crowded market. I personally think they may have overpiad for what ... http://www.qdinformation.com/qdisblog/2007/06/25/amgen-to-acquire-alantos/ I wanted to let readers know that the QDIS Blog now is mobile ready! If you want to look at the blog from a cell phone or other mobile device, then feel free. It will detect that you are accessing it on a mobile device and format it ... http://www.qdinformation.com/qdisblog/2007/06/25/qdis-blog-is-mobile-ready/ After upgrading to the latest Wordpress version about two weeks ago I had some problems getting my old theme to work. I finally got that fixed and the QDIS Blog is back now. The only minor issue right now is with the page navigation at the top. ... http://www.qdinformation.com/qdisblog/2007/06/23/qdis-blog-normal-theme-and-look-is-back/ Since I use Ambien on occasion it was good to hear Dr. Reddy's Lab is no approved to sell generic Ambien.Dr. Reddy's Gets Generic Ambien Approval - Forbes.com:I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription ... http://www.qdinformation.com/qdisblog/2007/06/16/dr-reddys-to-market-generic-ambien-2/ CNN Money had an article back in late May that discusses how the major pharma companies are becoming more like biotechs. Biotech drugs contribute heavily to Big Pharma sales - May. 29, 2007:This isn't too surprising if you consider the fact that biologic drugs have no generic competition. ... http://www.qdinformation.com/qdisblog/2007/06/02/biotech-drugs-contribute-heavily-to-big-pharma-sales/ I will be traveling on business to southern CA next week and so will likely not be able to post much. http://www.qdinformation.com/qdisblog/2007/06/01/traveling-next-week/ Dendreon hit a major snag last week when the FDA declined to approve the drug without further data. THese are somewhat misleadingly called "approvable letters. For more on approvable letters see What Do Approvable Letters Mean? from Mark over at Ee on FDA.Dendreon will delay Provenge, cuts jobs:This ... http://www.qdinformation.com/qdisblog/2007/05/29/dendreon-will-delay-provenge-cuts-jobs/ Contract Pharma has an article on Albany Molecular purchasing manufacturing facilities in India.AMRI Acquires Manufacturing Facilities in India - Contract PharmaWhat is surprising to me is how little they paid for it; $11 million for these assets which earned $5 million in revenue last year!It is interesting that some contract ... http://www.qdinformation.com/qdisblog/2007/05/29/amri-acquires-manufacturing-facilities-in-india/ I recently upgraded Wordpress and now my old theme for controlling the look of the site no longer works properly. I'm going with the Wordpress default until I can get the usual theme working again. Sorry for the change. http://www.qdinformation.com/qdisblog/2007/05/26/change-in-blog-look/ Avandia, the diabetes drug has been in the news quite a bit recently due to it possibly raising the risk of heart attack.UPDATE 1-EU agency says already aware of Avandia heart risk | Reuters FDA study said to show Avandia risk - Yahoo! News While I appreciate the information, I think it ... http://www.qdinformation.com/qdisblog/2007/05/25/avandia-and-heart-risk/ Seems three Indian companies have already moved to copy Sanofi's Acomplia (rimonabant) before it is even for sale in Europe and the US. The companies identified are Sun Pharmaceuticals, Torrent Pharma and Zydus Cadila.Sanofi's Acomplia already copied in India - paper:It should be noted that India patent law does ... http://www.qdinformation.com/qdisblog/2007/05/25/sanofis-acomplia-copied-in-india/ Merck is moving away from a long time approach of internal organic growth to one of strategic acquisitions of small companies.Merck & Co. keen on small acquisitions: executive - washingtonpost.com:It will be interesting to keep an eye on this and see how they mange this. THey are getting late ... http://www.qdinformation.com/qdisblog/2007/05/24/merck-to-acquire-small-companies/ Newsday has an article that illustrates how tough it is to deal with conflicts of interest in this case between advocacy groups and the pharmaceutical companies.Drug company payments to advocates an issue - Newsday.com:While the FDA has cracked down on advisory committee members and their ties to drug companies, the ... http://www.qdinformation.com/qdisblog/2007/05/23/conflicts-of-interest-in-pharmaceuticals/ Forbes has a report on Novartis purchasing the rights to NicQb, an anti-smoking vaccine from Cytos Biotechnology AG up to $500 million. The initial upfront payment is $29 million.Novartis Buys Right to Experimental Drug - Forbes.com:It will be interesting to watch and see how NicQb comes along. Currently ... http://www.qdinformation.com/qdisblog/2007/05/22/novartis-buys-right-to-anti-smoking-drug/ Since I use Ambien on occasion it was good to hear Dr. Reddy's Lab is no approved to sell generic Ambien.Dr. Reddy's Gets Generic Ambien Approval - Forbes.com:I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription ... http://www.qdinformation.com/qdisblog/2007/05/21/dr-reddys-to-market-generic-ambien/ Seems my old company is now paying $10.5 million to resolve claims that they were promoting Trisenox for uses that were not approved.Cell Therapeutics to pay $10.5 million:I always thought they were leaving them selves open for this sort of problems back when I was working for them given the ... http://www.qdinformation.com/qdisblog/2007/05/21/cell-therapeutics-to-pay-105-million/ Express scripts is now reporting that in five eyars, by 2012, biotech drugs will account for 25% of all expenditures on drugs. The market was $54 billion in 2006 and is expected to reach $99 billion by 2010. SignOnSanDiego.com > News > Business > Biotechnology -- Spending on biotech ... http://www.qdinformation.com/qdisblog/2007/05/21/spending-on-biotech-drugs-to-reach-25-by-2012/ This news is somewhat dated now but the M&A activity in the pharmaceutical industry continues. Now AsraZeneca is purchasing Medimmune for $15.6 billion.AstraZeneca to buy MedImmune for $15.6B - Yahoo! NewsThe two main products of interest are the children's respiratory drug Synagis and a refrigerated version of FluMist inhaled ... http://www.qdinformation.com/qdisblog/2007/04/28/astrazeneca-to-buy-medimmune-mergers-and-acquisitions-continue/ It isn't surprising that the FDA rejected Merck's NDA for Arcoxia, its follow on to Vioxx since an advisory committee already voted 20-1 against its approval. Forbes has an article on it. FDA Rejects Merck's Vioxx Successor - Forbes.com: It is interesting to note though that Arrcoxia is on sale in ... http://www.qdinformation.com/qdisblog/2007/04/28/fda-rejects-mercks-arcoxia/ Unfortunately I didn't take notes on Sunday during the talks so I'm having to write this from memory so it might not be as detailed as the previous two days. Most of the slides from the presentations will eventually be available to AIIP members on the AIIP website. Information Entrepreneur: Lesson ... http://www.qdinformation.com/qdisblog/2007/04/24/aiip-conference-2007-sunday/ Roger Summit Award Lecture Ambient Findability and the Future of Search Peter Morville, Semantic Studios The following is just my impressions of the talk and not a full well thought out posting. It's just sort of my thoughts. Peter has made the presentation available on his website and the link is ... http://www.qdinformation.com/qdisblog/2007/04/24/aiip-conference-2007-saturday/ Here are some of my reflections on Friday program of the 2007 AIIP conference. Awards Eiko Shaul, Presidents Award Ed Vawter (your truly), Sue Rugge Memorial Award Jan Davis, Connections Writers Award Jothi Nedungadi, Myra T. Grenier Award Keynote Speech ichael Roby - Motivational Speaker | Sales Trainer | Keynote Speaker | Sales Coach Becoming the ... http://www.qdinformation.com/qdisblog/2007/04/20/aiip-conference-2007-friday/ I apologize for not posting for a while. I have recently taken a new job and have been busy trying to get podcasts set up for my church and for an organization I belong to. These have eaten up large portions of my time. I do have a ... http://www.qdinformation.com/qdisblog/2007/04/16/not-posting-for-a-while/ Replidyne is continuing to refine its phase III efforts for the antibiotic faropenem. Replidyne Defines Preliminary Phase III Development Plan for Faropenem: Financial News - Yahoo! Finance: This new antibiotic may be the first to be approved under the FDA's new community standards for antibiotics. Technorati Tags: Faropenem, Replidyne http://www.qdinformation.com/qdisblog/2007/03/28/replidyne-defines-development-plan-for-faropenem/