http://www.jouhoukoukai.com This newsfeed provides enhanced coverage of "Regulatory and Commercial News" delivered by JKS en http://www.jouhoukoukai.com/images/jk_logo_s.gif http://www.jouhoukoukai.com 197 38 Jouhou Koukai Publishing is a business of JK Services LLC Copyright 2008 JK Services LLC regulatory(at)jouhoukoukai.com (Regulatory Dept.) mapping plans for the next 5 years, now soliciting public opinions including American Peptide Co. to expand its ingredients and API capacities for overhaul of social security system, possibly ministry's administrative restructuring an yet unapproved in Japan product indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS) of ICH Harmonised Tripartite Guideline "Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" required for approval of its negative pressure wound therapy (NPWT) technique in national newspapers soliciting Japanese citizens to protest 220 billion Yen health insurance cost-reduction plan of the Government including anti-cancer drugs in summer round of approval international harmonization of the Japanese Pharmacopoeia XV Institute of Medical Science, University of Tokyo admits falsifying IRB approval, retracts the published in May 2008 in Ferrata Storti Foundation medical journal Haematologica article (http://www.haematologica.org/cgi/content/full/93/7/1103); all photographs of the disgraced Arinobu Tojo removed from the web sites of University of Tokyo MHLW to revise the clinical research and tissue handling guidelines final decision on use restriction coming next "Drugs and Medical Devices Production Monitoring - Emphasis on GMP, QSM, Counterfeiting and Narcotics" held in Tokyo (former Head of the Public Affairs Office to the Cabinet Secretariat) as new Director-General of PAFSB, promotes Mr. Kazuhiko Mori to Head of the Safety Division to expand capabilities for "evaluating drug candidates as substrates, inhibitors and inducers of Cytochrome P450 enzymes" , Daiichi-Sankyo KK remains the only contender for Ranbaxy Laboratories Ltd (RLL) after expiration of the legal bid-logging period for dementia and juvenile dementia prevalence Pfizer KK became 3rd largest stockholder in RaQualia Souyaku KK to "prevent some groups or companies from monopolizing the iPS technology", the lead researcher says meaningful therapeutics 30 years away most of the key domestic and foreign pharmaceutical companies conspicuously absent from 650 exhibitors virus 1 during latent infection regulate viral mRNAs" - with a potential new approach for treatment of herpetic infections introduces new logo, content for mobile phone users projected to increase the demand for OTC smoking-cessation aids for executives and regular employees the CEO declares in WSJ interview plans to invest 4 billion Euro in 15 manufacturing sites around the world of Japanese pharma market value due to wider use of generics to be offsetted by 3.3 trillion Yen increase due to improved drug evaluation thus resulting eventually in 1.7 trillion Yen overall market shrinkage launched an original recycled PET bottles plastic caps collection initiative to raise funds for vaccine donations to developing countries in Asia (Amyotrophic Lateral Sclerosis, Parkinson, etc.) and to increase the number of targets from currently designated 123 conditions plan numerically targeting 70% recovery rate, much earlier diagnosis and increase of 5-year liver cancer survival rate from current 25% to 40% for the Second Supplement of the Japanese Pharmacopoeia XV Editions due in Spring 2009 authorized immediate approval of anti-HIV Isentress (Raltegravir) submitted by Banyu Seiyaku, pre-approved other products with Blopres as leading product,a decrease in Japan of biologicals sales to 5% global share in FY2007 to contribute in reaching 1 billion sales in two years held a meeting to discuss pricing methods for new drugs, market share calculations, generics, effect of 2008 cut India's largest pharmaceutical company for 4.6 billion US$ to secure share in world generic market that the in-licensed in 2006 from Protein Sciences Corp. FluBlok anti-H5N1 recombinant influenza vaccine is to enter in June 2008 Phase I trial in Japan underscores again the scale of undetected mental disorders and lack of psychiatric vigilance and the largest non-listed pharma company in Japan announced new corporate symbol and formation of holding organization declare the 2010 introduction of daylight saving time (summer time) unsuitable for Japanese population, forecasting serious damages of national health due to sleep disorders and 120 billion Yen of loses for drugs and medical fees declare the 2010 introduction of daylight saving time (summer time) unsuitable for Japan, forecasting serious damages of national health due to sleep disorders and 120 billion Yen of loses for drugs and medical fees by the description of the MHLW Minister Yoichi Masuzoe of CSIMS practices as "opaque" at the meeting of "Vision for Relief and Desired Medical Care Security" Committee NHI reimbursement prices of 23 formulations of new products; application of DPC (Diagnosis Procedure Combination) to new, high-priced drugs; review of medical treatment fee 2008 revision results opened in Tokyo with two days training sessions and follow-up CDISC Japan Interchange 2008 Conference of selective SGLT-2 inhibitors to GlaxoSmithKline Japan KK for development as anti-diabetic and anti-obesity therapeutics "no neckties, no jackets" summer style as a measure against global warming and for energy preservation that for FY 2007, all of its listed member companies recoded increased sales, including from overseas, but expect 20% decline on pretax profit due to price drug cut the suicides in 2007 including caused by depression and mental disorders is projected to exceed 30,000 for 10th consecutive year including pediatric medications and orphan drugs plan to ask the Government to stockpile anti-influenza vaccines for the entire population increasing its majority holding, but Chugai Seiyaku will not be delisted from Tokyo Stock Exchange increasing its majority holding, but Chugai Seiyaku will not be delisted from Tokyo Stock Exchange Other issues of concerns are the clinical trials, approval examination, trials in Asian region and patent terms extension. The JPMA has set up a task force to work on a proposal for a new drug price system. stock market reacts non-enthusiastically thus becoming one of the first Japanese pharma companies to scrap completely its anti-takeover - 10% of the population is now over 75 years old denouncing HMO and other for-profit initiatives as not applicable to Japan ranked Japan 22nd in "The World Competiveness Scoreboard 2008" among 55 economies to pay dividends and expand share-buyback program to 56 million eligible for the mandatory metabolic syndrome health check, the financial burden not relived by the central Government responsible for creating 10-years "Vision for Relief and Desired Medical Care Security" Mr. Yuya Miwa, a senior lawmaker from the ruling Liberal Democratic Party (LDP)and former Chairman of the LDP's Executive Council and Minister of Health and Welfare, in the keynote presentation at the meeting of the Japan Pharmacies Associations (NPhA) announced that Government's aim for 30% generics by 2012 is achievable even without US-style compulsory prescription demand 500 of listed firms to abolish takeover defenses, to reduce cross shareholding and to appoint 3 outside board members and over 50% drop in projected net profit for FY 2008 procedure for critical invention in biotech, healthcare and other high technologies ... details of Heparin-containing products approved in Japan are available in JAD Databases ... details of products approved in Japan are available in JAD Databases JAD Databases ... details of products approved in Japan are available in the JAD Databases ... details of products approved in Japan are available in the JAD Databases ... details of products approved in Japan are available in the JAD Databases Taisho Seiyaku KK remains as junior co-owner. plans to merge TAP with Takeda Pharmaceuticals North America Inc., to increase the sales staff to 4,300, and to move upward in global ranking from 17th to 14th position. and to dissolve all co-marketing agreements with domestic firms, including Daiichi Sankyo, Chugai Seiyaku, Fujisawa Sanofi-Aventis aiming to become the largest generics maker in Japan. as a part of restructuring its operations in Japan.