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Regulatory & Commercial News >>

2009 >>


September 30, 2009: JKS News: The pre-approval of Cervarix, domestically developed by GlaxoSmithKline Japan KK Cervarix packagesCervarix packages - 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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) CSIMC meeting (archival photo)CSIMC meeting (archival photo) - the all-powerful body used for decades by bureaucrats and special-interest groups such as Japan Medical Association Japan Medical Association HeadofficeJapan Medical Association Headoffice 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 Akira Nagatsuma, Minister of MHLWAkira Nagatsuma, Minister of MHLW , 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 Jichi Medical UniversityJichi 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 Novartis Pharma KK logoNovartis Pharma KK logo 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 Kitasato University School of PharmacyKitasato University School of Pharmacy and Harvard School of Public Health Harvard School of Public HealthHarvard 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 Dainippon Sumitomo Seiyaku KK officeDainippon Sumitomo Seiyaku KK office makes a 250 billion Yen TOB for Sepracor Inc. Sepracor's Marlborough headquartersSepracor's Marlborough headquarters as both firms suffer from strong generic competition ... Dainippon Sumitomo products in JAD Databases
September 2, 2009: JKS News: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo pre-approved Cervarix, domestically developed by GlaxoSmithKline Japan KK GSK headoffice in TokyoGSK headoffice in Tokyo 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) DPJ leader Senator Yukio Hatoyama, PhD in front of the election board with red rossetes on winning districtsDPJ leader Senator Yukio Hatoyama, PhD in front of the election board with red rossetes on winning districts - 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 Novartis Pharma KK logoNovartis Pharma KK logo 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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) NIIDNIID unveiled that influenza patients reported per medical institution in Japan has increased to the level indicating start flu epidemic; MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 Toray headoffice in Mitsui Tower, Nihonbashi, TokyoToray headoffice in Mitsui Tower, Nihonbashi, Tokyo , a Mitsui Group company is developing inhalation form of insulin; Novo Nordisk Pharma KK Novo Nordisk Pharma KK headoffice in Marunouchi, TokyoNovo Nordisk Pharma KK headoffice in Marunouchi, Tokyo announced submission of two additional variations of a rapid-acting Insulin Aspart; Nippon Eli Lilly KK Eli Lilly HQ in KobeEli Lilly HQ in Kobe 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 Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg 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 Daiichi-Sankyo brandmarkDaiichi-Sankyo brandmark 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. Biota logoBiota logo ,; 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) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) shares of Nippon Shinyaku KK Nippon Shinyaku headquarters and laboratories in KyotoNippon Shinyaku headquarters and laboratories in Kyoto 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 Daiichi-Sankyo brandmarkDaiichi-Sankyo brandmark : 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. Zenotech Laboratories facilityZenotech Laboratories facility (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 Japan Medical Association HeadofficeJapan Medical Association Headoffice 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 Eisai KK logoEisai KK logo 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo and PMDA PMDA Headoffice in TokyoPMDA Headoffice in Tokyo 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 Eisai KK logoEisai KK logo 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 Shionogi Seiyaku headoffice in OsakaShionogi Seiyaku headoffice in Osaka gained sharply on Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)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 PMDA Headoffice in TokyoPMDA Headoffice in Tokyo published 300-page comprehensive 2008 Annual Report ... PMDA consulting services
July 13, 2009: JKS News: The Minister of MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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 Takeo DoiTakeo 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 MHLW Headoffice in TokyoMHLW Headoffice in Tokyo 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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