●September 30, 2009: JKS News: The pre-approval of Cervarix, domestically developed by GlaxoSmithKline Japan KK   - as the first in Japan vaccine for cervical pre-cancerous lesions related to HPV 16/18, made mass media headlines; projected for final approval in October, pricing and market launch in December ... GSK KK products in JAD Databases | Vaccine report preview | Anti-cancer drugs in JAD Databases |
Report: Anti-cancers in Japan |
Cancer epidemiology consulting and data
●September 29, 2009: JKS News: The Committee of Drugs of PAFSC, MHLW  
recommended for approval 20 new products, including two vaccines, anti-emetic, anti-coagulant and anti-diabetics drugs ... Products under approval in JAD Databases | Unapproved products report preview
●September 28, 2009: JKS News: The role of the Central Social Insurance Medical Council (CSIMC)   - the all-powerful body used for decades by bureaucrats and special-interest groups such as Japan Medical Association   to influence the decisions on medical treatment fees and drug reimbursement, to be reformulated in line with the new Government policy ... CSIMC consulting services
●September 16, 2009: JKS News: The new administration of Democratic Party of Japan (DPJ) inaugurated, touted as the first "science" cabinet as having 5 science graduates members; Mr. Akira Nagatsuma   , a lawyer with history of confronting bureaucrats, became the Minister of Health, Labor and Welfare with primary focus on pensions and health insurance ... MHLW & PMDA consulting services | related reading
●September 14, 2009: JKS News: Survey carried out by the Jichi Medical University   revealed that for a second straight year the number of Kawasaki disease patients has exceeded 11,000 ... Epidemiology consulting and data
●September 12, 2009: JKS News: Novartis Pharma KK   to start on September 16 a voluntary safety trial on 200 healthy subjects and 100 children of its imported on emergency new A/H1N1 influenza vaccine, manufactured in canine MDCK cell line and containing unapproved in Japan adjuvant ... Novartis products in JAD Databases | Vaccine report preview
●September 11-12, 2009: JKS News: Kitasato University   and Harvard School of Public Health   jointly organized their 9th Symposium on "Advanced and Global Drug Development Techniques: Significance of Asian Studies in Simultaneous Global Clinical Trials" ...
●September 3, 2009: Dainippon Sumitomo Seiyaku KK   makes a 250 billion Yen TOB for Sepracor Inc.   as both firms suffer from strong generic competition ... Dainippon Sumitomo products in JAD Databases
●September 2, 2009: JKS News: The MHLW announced that the medical expenses in Japan reached 34.14 trillion Yen in FY2007 or 9.11% of GDP, as 52% of expenditures went for treatment of those over 65 years of age; the use of expensive advanced technology one of the reason for the rise ...
●September 1, 2009: JKS News:The Second Subcommittee of Drugs of Pharmaceutical Affairs Committee of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) to the MHLW pre-approved Cervarix, domestically developed by GlaxoSmithKline Japan KK   as the first in Japan vaccine for cervical pre-cancerous lesions related to HPV 16/18 ... GSK KK products in JAD Databases | Vaccine report preview | Anti-cancer drugs in JAD Databases | Report: Anti-cancers in Japan | Cancer epidemiology consulting and data
●August 31, 2009: JKS News: General election winner - the Democratic Party of Japan (DPJ)   - to form a cabinet for the first time starting with setting up the Office For National Strategy, changes in healthcare bureaucracy, policy and budget on the horizon ... related reading
●August 28, 2009: JKS News: After successfully entering Japan - the third largest vaccine market with Vaxem-HibR vaccine for the prevention of infection caused by Haemophilus influenzae type B (Hib), Novartis Pharma KK announced that will initiate on its own accord clinical testing in Japan on the efficacy and safety of its new A/H1N1 influenza vaccine in spite of possible emergency exemption of PAL requirements ... Novartis products in JAD Databases
●August 24, 2009: JKS News: In line with the "Action Program for Promotion of the Safe Use of Generics" the MHLW publicized the results of FY 2008 quality re-evaluation of 876 generic products, two products recalled ... Generic products in JAD Databases | Generics report preview
●August 20, 2008: JKS News: The National Institute of Infectious Diseases (NIID)   unveiled that influenza patients reported per medical institution in Japan has increased to the level indicating start flu epidemic; MHLW declared that outbreak of new H1N1 strain of influenza A has reached pandemic proportion ... Epidemiology consulting and data
●August 18, 2009: Diabetes news: Toray KK   , a Mitsui Group company is developing inhalation form of insulin; Novo Nordisk Pharma KK  announced submission of two additional variations of a rapid-acting Insulin Aspart; Nippon Eli Lilly KK   will seek approval for Exenatide ... Anti-diabetes products in JAD Databases | Metabolic Syndrome report preview | Epidemiology of diabetes data
●August 14, 2009: Survey: Tokyo Shoko Research KK, the oldest credit reporting agency in Japan, found that over 21,000 enterprises in Japan are over 100 old, as Takeda Yakuhin Kogyo KK   the oldest pharma company with 218 year of history - relatively short in comparison with 1,431-year old construction company Kongo Gumi ... related reading
●August 12, 2008: JKS News: Daiichi Sankyo KK   announced the successful completion of Phase III global study on 1,000 patients from Japan, Taiwan, South Korea and Hong Kong of its second generation long-acting inhaled neuraminidase inhibitors (LANI) anti-influenza agent CS-8958 (laninamivir), developed by Australian Biota Holdings Ltd.   ,; found the new product to be more effective than Tamiflu in children aged 9 and lower ... Antivirals in JAD Databases
●August 11, 2009: JKS News: At Tokyo Stock Exchange (TSE)   shares of Nippon Shinyaku KK   rose after the announcement for successful completion of clinical trials of the licensed from Merck Serono International SA acamprosate (Campral) as first treatment of alcoholism in Japan ... Nippon Shinyaku products in JAD Databases
●August 10, 2008: JKS News: Busy days for Daiichi Sankyo KK : established a new "Vaccine Business Planning Department", sold its Shizuoka-based tablets factory; commenced an open offer for the shares of Indian generic biopharmaceuticals maker Zenotech Laboratories Ltd.   (presently blocked by a decision of India Securities Appellate Tribunal); U.S. District Court favored Daiichi Sankyo in a patent litigation against Mylan Inc. / Matrix Laboratories Ltd. for olmesartan-containing Benicar, Benicar HCT and Azor product lines ... Daiichi Sankyo products in JAD Databases
●August 9, 2007: Kyodo News KK: survey found that support to the ruling coalition among the medical practitioners is falling fast prior the general elections; no comments from the special-interest group - Japan Medical Association or its political wing - Nihon Ishi Renmei (Japan Doctors' League) ...
●August 3, 2009: Japan Aerospace Exploration Agency (JAXA) disclosed that the Japanese astronaut on the latest 4-month mission to the International Space Station has self-conducted trial with osteoporosis drug on behalf of anonymous pharma sponsor ... Anti-osteoporosis drugs in JAD Databases
●July 31, 2009: JKS News: The Second Subcommittees of Drugs of PAFSC, MHLW recommended for approval hepatocellular carcinoma treatment, vascular tumor contrast agent, vancomycin eye ointment ... Anti-cancer drugs in JAD Databases | Report: Anti-cancers in Japan
●July 28, 2009: Eisai KK   to seek approval in Switzerland for its first in-house developed anti-cancer drug ... Eisai products in JAD Databases
●July 27, 2009: JKS News: The MHLW and PMDA   reminded the eligible cardiovascular device makers to comply with July 31st deadline for proposals related to the "Pilot Program on Sharing Information Between the US FDA and Japan MHLW/PMDA Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications" aimed to process at least two applications by year-end ... MHLW & PMDA consulting services | "Drug lag" report preview
●July 23, 2009: Eisai KK obtained approval for honey-lemon-flavored jelly formulation of Aricept intended for easier intake by elderly Alzheimer patients ... Eisai products in JAD Databases
●July 22, 2009: JKS News: Stock price of Shionogi Seiyaku KK   gained sharply on Tokyo Stock Exchange (TSE) after the successive announcement of successful completion of Phase IIa clinical trial in South Africa by the Shionogi-GlaxoSmithKline Pharmaceuticals, LLC on an HIV candidate (S/GSK1349572, once-daily, unboosted integrase inhibitor) and highly positive domestic Phase III outcome for new anti-flu drug Peramivir (neuraminidase inhibitor, S-021812) ... Shionogi products in JAD Databases
●July 15, 2009: JKS News: PMDA published 300-page comprehensive 2008 Annual Report ... PMDA consulting services
●July 13, 2009: JKS News: The Minister of MHLW granted approval in July of 20 formulations of 10 products, including the Novartis' first-in-class direct renin inhibitor Rasilez (aliskiren, Tekturna) ... Approved products in JAD Databases
●July 10, 2009: The MHLW in association with major medical universities and teaching hospitals set up a task force to carry out data mining of interferon treatment results of nearly 2 millions patients with Hepatitis C ... Interferon products in JAD Databases | Hepatitis reports
●July 9, 2009: JKS News: In a major domestic and international expansion move Takeda Yakuhin Kogyo KK began the construction of its largest unified research facility in Japan, set up Asian regional headquarters in Singapore, in addition to the three existing subsidiaries (Takeda Clinical Research Singapore Pte Ltd, Takeda Pharmaceuticals Asia Pte Ltd, Takeda Singapore Pte Ltd) ... related reading
●July 7, 2009: JKS News: The MHLW ordered revision of the package inserts for a number of antidepressants and antiepileptic drugs to include warning for such serious side effects as rhabdomyolysis, acute renal failure, interstitial nephritis, suicidal ideation and suicide attempts ... CNS products in JAD Databases | CNS product consulting | Depression report preview
●July 6, 2009: JKS News: Dr. Takeo Doi   , a prominent psychiatry researcher and internationally acclaimed author of seminal "The Anatomy of Dependence" passed away ... related reading
●July 1, 2009: JKS News: The MHLW held the first working meeting to the new "Five-year Clinical Trials Revitalization Plan"; started to review the outcome of the current "Three-year Clinical Trials Revitalization Plan" set up in 2007 to target the hospital-based medical centers and to encourage the investigator-initiated trials ... Report on "Three-year Clinical Trials Revitalization Plan"
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