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Regulatory & Commercial News >>

2010 >>


June 28, 2010: JKS News: Eisai KK Eisai KK logoEisai KK logo announced: that has obtained two additional indications in Japan of its proton pump inhibitor Pariet (Rabeprazole sodium): for non-erosive gastroesophageal reflux disease (GERD), and also has obtained approval as concomitant therapy with combination of proton pump inhibitor (rabeprazole sodium), amoxicillin hydrate, and either clarithromycin or metronidazole indicated for the eradication of H. pylori in gastric MALT lymphoma, idiopathic thrombocytopenic purpura and in stomach after endoscopic resection of early stage gastric cancer; that the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo granted priority review status to the Marketing Authorization application for eribulin mesylate (E7389) for treatment of inoperable or recurrent breast cancer; that under the "over 100 million Yen annual salary" disclosure rule imposed by the Financial Service Agency (FSA) Financial Service Agency (FSA) headoffice in Kasumigaseki Common Gate building in TokyoFinancial Service Agency (FSA) headoffice in Kasumigaseki Common Gate building in Tokyo Mr. Haruo Naito Eisai KK NaitoEisai KK Naito , President & CEO appeared to be the highest paid Japanese pharma executive with 136 million Yen compensation ... Eisai products in JAD Databases
June 24, 2010: Flu pandemic in Japan (update 11) - vaccines: The UMN Pharma KK (Unmet Medical Needs Pharma) UMN Pharma logoUMN Pharma logo and its main corporate backer - the IHI Plant Engineering KK IHI Plant Engineering KK logoIHI Plant Engineering KK logo (of IHI Group) established a JV company Unigen KK to cell-culture manufacturing of A/H5N1 avian influenza vaccine from 2012; after 10 years hiatus Takeda Yakuhin Kogyo KK Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg is returning to flu vaccine production with plans to start in 2014 producing avian influenza vaccine using cell culture technology licensed from Baxter International; the Infectious Disease Surveillance Center reported that at least 28 new types and subtypes of influenza virus have entered Japan from overseas during the May-September 2009 outbreak ... Anti-flu products in JAD Databases | Epidemiology consulting and data | Key report preview
June 21, 2010: JKS News: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo announced that the Government will expand by 2020 the current pilot system of Advanced Medical Treatment centers into 200 selected institutions where unapproved pharmaceuticals and medical devices could be used based on the experience and decisions of physicians and patients consent; yet current restrictions on the mixed treatment co-payment are not projected to be removed ... Reimbursement and health insurance info consulting services | Unapproved Medicinal Products
June 18, 2010: JKS News: The new Cabinet Prime Minister Office in TokyoPrime Minister Office in Tokyo revealed the details of the finalized "New Growth Strategy (Basic Policies) Toward a Radiant Japan" document outlining the aims of the Government to revitalized economy by 2020: expanding the medical service field into 59 trillion Yen business with new 2.8 million jobs; increasing the opportunities for medical tourism to reach 500,000 foreign patients annually; increasing the number of physicians by allowing opening of new medical schools ... Governmental information
June 14, 2010: JKS News: After obtaining reimbursement price of June 11, 2010 Alexion Pharma KK announced the availability for Japanese patients of paroxysmal nocturnal hemoglobinuria (PNH) of Soliris (eculizumab) Solution for IV drip infusion 300 mg Soliris vial, packageSoliris vial, package - a humanized monoclonal anti-complement (C5) inhibitor and first product in Japan for treatment of PNH ... Product details in JAD Databases
June 10, 2010: Mental health news: The Cultural Affairs Council Cultural Affairs Agency, Ministry of Education, Culture, Sports, Science and Technology, MEXTCultural Affairs Agency, Ministry of Education, Culture, Sports, Science and Technology, MEXT in the first in 30 years revision of the list of characters for common use, recommended the inclusion of 196 new characters, including some rare and difficult to write such as "utsu" Character for depression, utsuCharacter for depression, utsu used in the term for psychological depression; the inaugurated in January "Suicide and Depression Preventive Measures" Project Team PT session chaired by MHLW Minister Akira NagatsumaPT session chaired by MHLW Minister Akira Nagatsuma has finalized a proposal to amend the Industrial Safety and Health Law so from FY 2011 a basic verification of the mental condition to be included in the mandatory annual employees health check; the National Police Agency survey showed 32,845 people have committed suicide in 2009, unemployment-related the fastest growing segment ... Anti-depression products in JAD Databases | Depression report preview | Epidemiology of depression in Japan | Archived news
June 8, 2010: JKS News: The Japan Pharmaceutical Manufacturers Association (JPMA) JPMA Office bldg in TokyoJPMA Office bldg in Tokyo has released the proceedings of the symposium "Current State of Computerization of Application for Approval and Re-examination" sponsored by the Computerized Information Subcommittee of the Drug Evaluation Committee of JPMA; the number of eCTD submitted in 2009 reported to have exceeded 40 ... eCTD consulting and data  |  Key reports
June 4, 2009: JKS News: The MHLW controlled National Institute of Biomedical Innovation National Institute of Biomedical Innovation in IbarakiNational Institute of Biomedical Innovation in Ibaraki , known for its contribution to orphan drug development, has launched an open for the general public web site of the newly established Nanbyo Kenkyu Shigen Bank (Rare Disease Biospecimen Bank) aimed at collection of specimen from patients of about 130 intractable disorders; the collection is expected to valuable in medical research and drug development ... Orphan drugs (ODD) in JAD Databases | Report preview
June 1, 2010: Nichi-Iko / sanofi-aventis update (4): Mr. Tomoichi Tamura Nichi-Iko CEONichi-Iko CEO - President & CEO and son of the founder announced bold plans for collaboration in both conventional and biogenerics: the new 3 billion Yen R&D facility Nichi-Iko R&D facility (image)Nichi-Iko R&D facility (image) constructed in Namekawa, Toyama Prefecture to become the largest in the country with capacity to produce antibodies and other biosimilar products utilizing recombinant DNA techniques ... Generics in JAD Databases
May 31, 2010: Nichi-Iko / sanofi-aventis update (3): The new JV under the name Nichi-Iko sanofi-aventis KK capitalized at 100 million Yen is slated to start in June; the President & CEO of sanofi-aventis KK Mr. Patrick Chocat Sanofi-aventis KK CEOSanofi-aventis KK CEO - is to named also President & CEO of the new entity, initially to be based in the headquarters Sanofi-aventis KK headofficeSanofi-aventis KK headoffice of sanofi-aventis KK in Tokyo; the joint company initiated the business with sales of Amoban and later with other sanofi-aventis products with expired patents by trying to take advantage of the extensive sales network of Nichi-Iko ... Patent expiration and generics consulting | Insomnia products in JAD Databases
May 28, 2010: Nichi-Iko / sanofi-aventis update (2): On June 16, 2010 Nichi-Iko KK shall issue 4.442 billion Yen worth of common shares to be purchased by sanofi-aventis KK Sanofi-aventis KK headofficeSanofi-aventis KK headoffice thus making it the third largest shareholders after Tamura family and Hokuriku Bank; the Senior Vice President of sanofi-aventis S.A. Mr. Olivier Charmeil Sanofi-aventis SVPSanofi-aventis SVP has indicated that the company would be willing to obtain larger stake in Nichi-Iko KK if invited ... sanofi-aventis products in JAD Databases
May 27, 2010: JKS News: In conflicting reports, Dow Jones Japan cited Mr. Christopher Viehbacher Sanofi-aventis CEOSanofi-aventis CEO, the CEO of sanofi-aventis SA announcing at a press conference plans to enter generics market in Japan, but declining to name the potential partner; earlier in the day, the business daily Nihon Keizai Shimbun Nihon Keizai Shimbun HQNihon Keizai Shimbun HQ reported that sanofi-aventis KK Sanofi-aventis KK headofficeSanofi-aventis KK headoffice would form capital and operational tie-up, and a new 51:49 joint venture entity with the largest generic manufacturer in Japan - the listed Nichi-Iko Seiyaku KK Nichi-Iko Seiyaku headofficeNichi-Iko Seiyaku headoffice ... Generics in JAD Databases | Generics report preview
May 18, 2010: JKS News: In its latest metamorphosis, OSI Pharmaceuticals Inc. OSI logoOSI logo once a NCI/NIH academic spin-off and formerly Oncogene Science, Inc. to become a subsidiary of Astellas Seiyaku KK Astellas logoAstellas logo; in Japan Astellas to inherit complex relations with Chugai Seiyaku KK Chugai Seiyaku headoffice in Mitsui Honkan BldgChugai Seiyaku headoffice in Mitsui Honkan Bldg - the holder of the Manufacturing and Sales Approval for OSI's Tarceva (Erlotinib hydrochloride), and HER 1/EGFR Inhibitor registered in 2007 for treatment of NSCLC ... Astellas products in JAD Databases | Epidemiology of lung cancer in Japan
May 17, 2010: Vaccines update: In Tochigi Prefecture, a group of elementary school female students have been vaccinated with Cervarix, domestically developed by GlaxoSmithKline KK Cervarix packagesCervarix packages against cervical pre-cancerous lesions related to HPV 16/18 in a campaign noted to be the first anti-cancer vaccination in Japan fully subsidized by the state; in collaboration with Sanofi Pasteur, Sanofi-aventis KK Sanofi-aventis KK headofficeSanofi-aventis KK headoffice and Kitasato Kenkyujo, the newly formed vaccine unit of Daiichi-Sankyo KK Daiichi-Sankyo HQ, TokyoDaiichi-Sankyo HQ, Tokyo announced plans to launch measles-rubella combination vaccine in FY 2011 and first inactivated polio quadruple DPT-polio vaccine; the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo to hold the 5th Anti- New Influenza (N1H1) Measures General Meeting on May 19th ... Vaccines in JAD Databases | Vaccine report preview
May 14, 2010: JKS News: Daiichi-Sankyo KK Daiichi-Sankyo brandmarkDaiichi-Sankyo brandmark to replace Mr. Takashi Shoda Mr. Takashi ShodaMr. Takashi Shoda who successfully led the company through the merger between Daiichi and Sankyo in 2005 with the current Executive Vice President Mr. Joji Nakayama Mr. Joji NakayamaMr. Joji Nakayama - joining the company after the acquisition of Suntory's ex-pharma business; the new management to continue the expansion into generics, to grow the vaccine franchise and to focus on emerging markets amidst the uncertainty from fluctuating Ranbaxy value and the imminent 2010 patent shock ... Daiichi Sankyo products in JAD Databases | Patent expiration and generics consulting
May 13, 2010: JKS News: The Diet Japan National Diet building in TokyoJapan National Diet building in Tokyo passed the amended National Health Insurance Law to increase the income-proportional individual, corporate and public contributions aimed to ease the social support for over 75 yo elderly ... Japan health insurance consulting | Related report preview
May 10, 2010: JKS News: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo announced that the Government will subsidize 50% of the minimum amount of medical fee for one category of low-income individual under the age of 70 yo ... Treatment guidelines consulting
May 8, 2010: JKS News: The Nippon Denki KK (NEC) Headquarters tower of Nippon Denki KK (NEC) in TokyoHeadquarters tower of Nippon Denki KK (NEC) in Tokyo to launch new and affordable cloud computing based medical record keeping service targeting mid-size (100-399 beds) and small-size (21-99 beds) hospitals, where the current penetration of electronic medical records is 18% and 10%, respectively ... E-health report | Ehealth Japan
May 7, 2010: JKS News: Amidst the falling prices at the Tokyo Stock Exchange (TSE) Tokyo Stock Exchange (TSE)Tokyo Stock Exchange (TSE) shares of Takeda Yakuhin Kogyo KK Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg climbed sharply following the disclosure that the company has reached deals with six out of the eight generic makers planning to launch cheaper versions of Actos and Actoplus immediately after the patent expiration in January 2011; further as a countermeasure of "2010 problem" Takeda will seek an approval for a new antihypertensive product (TAK-491) to succeed Blopress in US market ... Takeda products in JAD Databases
May 6, 2010: The major daily Yomiuri Shimbun Yomiuri Shimbun HQYomiuri Shimbun HQ survey of the 1,477 institutional members of Japanese Association of Neuro-Psychiatric Clinics found that nearly 70% of the respondents consider the current treatment guidelines to overuse anti-depressants ... Anti-depression products in JAD Databases | Depression report preview | Epidemiology of depression in Japan | Archived news
April 30, 2010: JKS News: The MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo released the complete translation into Japanese, including instructions for the implementation of the eCTD IWG Q&A Version1.18 ... eCTD consulting and data  |  Key reports
April 29, 2010: Drugstore industry (Update 2): All leading drugstore operators, including Aeon KK Aeon KK headoffice in ChibaAeon KK headoffice in Chiba CSF Corporation KK CSF Corporation logoCSF Corporation KK logoin collaboration with Yakuji KK, the industry No. 2 Sugi Holdings KK; the industry No. 3 Cocokara Fine Holdings KK Cocokara Fine Holdings KK logoCocokara Fine Holdings KK logo; Growell Holdings KK (Welcia Kanto KK); and Segami Medics KK to build special-purpose dispensing pharmacies (equipped with hi-tech sterile rooms) to dispense medications intended for distribution by trained pharmacists to the growing number of patients treated in individual or nursing homes ... Drugstore operations consulting
April 26, 2010: JKS News: Alarmed by not decreasing below 30,000 per year number of suicides in Japan, the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo plan to included from the FY 2011 a basic mental condition examination during the mandatory annual health checks of all insured ... Anti-depression products in JAD Databases | Depression report preview | Epidemiology of depression in Japan | Archived news
April 22, 2010: JKS News: Iceland volcanic ash severely disrupted air deliveries from Europe of Molybdenum 99 shipped weekly due to short half-life ... Radiopharmaceuticals in JAD Databases
April 19, 2010: JKS News: In the spring round of approval the MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo approved 31 new products and formulations, including record 5 products in 9 formulations Takeda Yakuhin Kogyo KK Takeda Yakuhin Kogyo KK HQ in Osaka Midosuji BldgTakeda Yakuhin Kogyo KK HQ in Osaka Midosuji Bldg and the anticancer Vectibix (Panitumumab) - the first product to be launched by its subsidiary Takeda Bio Development Center KK, the fully integrated now former Amgen KK ex-Amgen KK office in Sapia Tower, TokyoAmgen KK office in Sapia Tower, Tokyo ... Product details in JAD Databases
April 17, 2010: Flu pandemic in Japan (update 10) - first wrap-ups: Japan emerged from the 2009-10 influenza pandemic season quite unscathed with just 198 deaths and much fewer pregnant women among the victims, but with the world's largest stockpile of 107 millions doses of unused vaccines; MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo plan a revision of the Preventive Vaccination Law, development within 5 years of domestic cell-culture based vaccine production, subsidizing and better balancing of the financial burden in the next flu seasons ... Anti-flu products in JAD Databases | Epidemiology consulting and data
April 5, 2010: JKS News: The Japan Medical Association Japan Medical Association HeadofficeJapan Medical Association Headoffice - one of the most conservative and financially influential special-interest groups continuously backing the LDP, overhauled its management, switched the allegiance to the ruling Democratic Party of Japan ... Consulting services
April 1, 2010: JKS News: The Medical Economics Division of the Health Insurance Division, MHLW MHLW Headoffice in TokyoMHLW Headoffice in Tokyo announced the biannual price cut: in 2010 round the average reduction of the official reimbursement prices for 15,455 products is 5.75% ... Drug price services | Report preview


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