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Regulatory & Commercial News >>

2010 >>


March 31, 2010: JKS News: PMDA PMDA Headoffice in TokyoPMDA Headoffice in Tokyo to announce the results of bidding for building and maintaining an intra-agency system for new drug application dossier reviewing and eCTD handling ... eCTD consulting and data  |  Key reports
March 26, 2010: JKS News: GlaxoSmithKline PLC GSK headoffice in TokyoGSK headoffice in Tokyo to purchase from Mitsui Busan Principal Investments KK Office building of Mitsui Busan Principal Investments KK in Otemachi, TokyoOffice building of Mitsui Busan Principal Investments KK in Otemachi, Tokyo over 3 millions common shares of Nippon Chemical Research KK JCR KK logoJCR KK logo - a developer of enzyme-replacement therapies (ERT) and biosimilars thus gaining 25% control of the company ... Biosimilars consulting  |  Related reading
March 24, 2010: JKS News: In a long time not seen pharma company IPO, the API maker Daito KK Daito KK logoDaito KK logo debuted in the second section of the Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) , stock raised over the initial price ... Generics in JAD Databases | Generics report preview
March 18, 2010: JKS News: PMDA PMDA Headoffice in TokyoPMDA Headoffice in Tokyo published an extensive report on the agency's activities in the FY 2009 related to quasi-drug new requirements, approvals and review ... Quasi-drug consulting services
March 16, 2010: Drugstore industry realignment: Two major drugstore operators to be delisted from the Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) due to industry reshaping mergers and acquisitions: the leading leading retailer Aeon KK Aeon KK headoffice in ChibaAeon KK headoffice in Chiba to obtain controlling 51% stake in CSF Corporation KK CSF Corporation logoCSF Corporation KK logo, plans to make it core for drugstore and cosmetics operations; Cocokara Fine Holdings KK Cocokara Fine Holdings KK logoCocokara Fine Holdings KK logo to absorb Allied Hearts Holdings KK Allied Hearts Holdings KK logoAllied Hearts Holdings KK logo and form a new entity on October 1, 2010 ... Drugstore operations and OTC consulting
March 12, 2010: Flu pandemic in Japan update (9) - epidemics abates: The National Institute of Infectious Diseases (NIID) NIIDNIID estimated the number of infected to have reached 20.63 millions, however the epidemics clearly abates - the number of patients per monitoring institution drops to 0.77 - all time low; the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo announce that none of the Britain's GlaxoSmithKline PLC GSK headoffice in TokyoGSK headoffice in Tokyo and only 150 of the Switzerland's Novartis AG Novartis Pharma KK logoNovartis Pharma KK logo - manufactured flu vaccines have been actually applied, 99 millions remain and now expiring; approximately one-third of all domestically-produced 54 million anti-flu shots have been used, what makes the number of vaccinated about 18 millions ... Anti-flu products in JAD Databases | Epidemiology consulting and data
March 10, 2010: Research findings cited by Nihon Keizai Shimbun Nihon Keizai Shimbun HQNihon Keizai Shimbun HQ show that in spite of sales deregulations for OTC drugs the actual sales in 2009 have decreased by 0.4% due to the significant number of people visiting clinics instead of purchasing cold medicines by themselves ... OTC registration and consulting services
March 8, 2010: JKS News: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo in conjunction with the Drug Price Subcommittee of the Central Social Insurance Medical Council (CSIMC) CSIMC meeting (archival photo)CSIMC meeting (archival photo) announced the plan for 10 years post-approval price protection for all patented drugs; orphan and other niche products are projected to benefit most ... Drug price services | Report preview
March 5, 2010: JKS News: Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) announced the 2009 Listed Company Awards: Kyowa Hakko Kirin KK Kyowa Hakko Kirin KK logoKyowa Hakko Kirin KK logo granted the 15th Corporate Disclosure Award ... Kyowa Hakko Kirin products in JAD Databases March 4, 2010: JKS News: PMDA PMDA Headoffice in TokyoPMDA Headoffice in Tokyo released the updated Japan Drug Master Files listing of over 7,000 entries ... JMF details in JAD Databases  |  Key report reading
March 3, 2010: JKS News: The Japanese subsidiary Lundbeck KK Lundbeck Japan KK office building in Kamiyacho, TokyoLundbeck Japan KK office building in Kamiyacho, Tokyo to start with Takeda Yakuhin Kogyo KK Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg two local trials of new investigational anti-depressants ... Lundbeck products in JAD Databases | Full text | Depression report preview | Epidemiology of depression in Japan | Previous news
February 22, 2010: In the Nihon Keizai Shimbun Nihon Keizai Shimbun HQNihon Keizai Shimbun HQ 2010 annual survey for the 100 most desirable companies to work conducted among the future graduates from major universities nation-wide the only pharmaceutical company - Takeda Yakuhin Kogyo KK Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg ranks at 66th place (down from 48th in 2009) ... Takeda products in JAD Databases
February 12, 2010: JKS News: The price at Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) of SS Seiyaku KK SS Seiyaku KK logoSS Seiyaku KK logo gained 20% after Boehringer Ingelheim GmbH / Nippon Boehringer Ingelheim KK Nippon Boehringer Ingelheim KK headoffice in ThinkPark Tower OsakaNippon Boehringer Ingelheim KK headoffice in ThinkPark Tower Osaka launched a tender offer for all outstanding shares of third largest OTC / generic maker in Japan ... products details in JAD Databases
February 1, 2010: JKS News: PMDA PMDA Headoffice in TokyoPMDA Headoffice in Tokyo updates the comprehensive information on quasi-drug regulations, including the draft requirements for the raw ingredients ... OTC, BTC and quasi-drug consulting services
January 25, 2010: Diabetes news: Banyu Seiyaku KK Banyu Seiyaku KK office building in TokyoBanyu Seiyaku KK office building in Tokyo , a Merck &C. group company buoyed by the prospects for the first-of-class DPP-4 (dipeptidyl peptidase IV) inhibitor Januvia (sitagliptin) in the diabetes market in Japan, projected to grow by 50% by 2017 to 377 billion Yen ... Anti-diabetes products in JAD Databases | Metabolic Syndrome report preview | Epidemiology of diabetes data
January 21, 2010: Flu pandemic in Japan update (8) - vaccine glut: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo approved the use, but may cancel part of the purchase contract for 9.9 million doses of foreign-made anti-H1N1 vaccines (7.4 million doses of Pandemrix and 2.5 million doses of Celtura) after only one prefecture in Japan requested just 200 doses of products imported by the domestic subsidiaries of by Britain's GlaxoSmithKline PLC GSK headoffice in TokyoGSK headoffice in Tokyo and Switzerland's Novartis AG Novartis Pharma KK logoNovartis Pharma KK logo ; the distribution of the imported vaccines - made by using cell cultures and containing no unapproved adjuvant (MF59) to start in February as 10,000-subject PMS is scheduled to offset the limitation of emergency 100-subject pre-approval trial; the National Institute of Infectious Diseases (NIID) NIIDNIID estimated the number of infected to have reached 19.23 millions ... Anti-flu products in JAD Databases | Epidemiology consulting and data
January 3, 2010: Generics News: The JV company Teva-Kowa Pharma KK Building with the Headquarters of Teva Pharmaceuticals KK in TokyoBuilding with the Headquarters of Teva Pharmaceuticals KK in Tokyo to launch on 5th of January, 37 new generics - first batch of scheduled nearly 300 products ... Generics in JAD Databases | Generics report preview
January 13, 2010: Flu pandemic in Japan update (7): Shionogi Seiyaku KK Shionogi Seiyaku headoffice in OsakaShionogi Seiyaku headoffice in Osaka granted Marketing and Manufacturing Approval for two formulations of Rapiacta (Peramivir): 300 mg bag for i.v. drip infusion and 15 mg vial for i.v. drip infusion, developed in Japan under license from BioCryst Pharmaceuticals, Inc. BioCryst Pharmaceuticals logoBioCryst Pharmaceuticals logo for treatment of infections with influenza A and B virus strains after a record short development period including Phase III multi-national (Japan, Taiwan, S. Korea) study and submission in November 2009; nation-wide epidemiological study led by the Japan Science and Technology Agency (JST) Japan Science and Technology Agency, Kawaguchi, SaitamaJapan Science and Technology Agency, Kawaguchi, Saitama found that those aged over 6o are far less susceptible to the new influenza due to previous epidemics in 1940s ... Anti-flu products in JAD Databases | Epidemiology consulting and data
January 8, 2010: JKS News: In a move toward streamlining health insurance schemes, the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo revealed premium disparity among the 3,500 public medical insurance programs, including the 1,474 corporate health insurance associations and Japan Health Insurance Association (Kyokai Kempo); announced a bid to curb the subsidies paid to insurance associations of self-employed (physicians, construction laborers) - widely believed to be vote-gathering centers ... Pricing & Reimbursement consulting


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