●June 30, 2009: JKS News: The Japan Society of Generic Medicines (JSGM, GE Academy)   announced a major proposal for the revision of medical fees for the scheduled price changes in April 2010 ... Generic products in JAD Databases | Generics report preview
●June 29, 2009: JKS News: The MHLW   granted Marketing Authorization for first biosimilar product in Japan: generic Somatropin imported by Sandoz KK   for treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency ... Somatropin products in JAD Databases | Biosimilars (biofollowing products) consulting
●June 26, 2009: JKS News: The Economic Affairs Division, Health Policy Bureau, MHLW announced results from FY2008 survey on actual use of generics: accounted for 7.2% of all prescription spending (0.4% increase vs. FY2007), with highest (21.1%) share in the category of cardio-vascular drugs in hospitalized patients ... Generics report preview
●June 25, 2009: JKS News: The Pharmaceutical Affairs Committee of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), MHLW recommended for final approval in July the Novartis' first-in-class direct renin inhibitor Rasilez (aliskiren, Tekturna), other 19 formulations of 10 products ... Products under approval in JAD Databases
●June 24, 2009: JKS News: Nomura Asset Management KK   in association with Pictet Asset Management (Japan) KK   launched domestically 10-year "Nomura Pictet Generics & Genome Fund" ... Generics report preview
●June 22, 2009: JKS News: In FY2008 Dainippon Sumitomo Seiyaku KK   emerged as the only major pharma to become completely debt-free; plans announced to set-up holdings in US ... Dainippon Sumitomo products in JAD Databases
●June 20, 2009: PMDA   started soliciting public tenders for "Business Support for ICH E2B/M2 Electronic Specification Development", eligible vendors are expected to possess high proficiency in XPATH, full compliancy to Health Level 7 requirements; protection of personal information ...
eCTD and electronic documentation consulting | Related laws
●June 19, 2009: JKS News: The MHLW revised the "Guidelines for Securing Medical Care, Quarantine and Handling the Requests for Temporary Closing of Schools and Child-care Facilities"; described the diagnostic/treatment flow of fever patients; anti new flu vaccine to produce from mid-July ... Epidemiology consulting and data
●June 18, 2009: JKS News: The MHLW formed a new committee to review until August 17, 2009 suggestions for unregistered in Japan QOL-improving or orphan drugs already approved in US, UK, Germany or France, and not included in the current list of "Unapproved Medicinal Products" to be considered for a financial and regulatory support if a sponsor agreed to develop it domestically ... Report preview
●June 17, 2009: Study conducted by Nihon Keizai Shimbun   revealed Astellas Seiyaku KK   had a return on equity of 15.99%, the highest among major manufacturers for the FY 2008 ... Astellas products in JAD Databases
●June 16, 2009: JKS News: Order-Made Souyaku KK to start trials in China with licensed-in vaccine for liver cancer; at Tokyo Stock Exchange (TSE)   shares of the licensor OncoTherapy Science KK   went off-limit in the trading ... OncoTherapy Science products in JAD Databases
●June 15, 2009: JKS News: As the World Health Organization (WHO) raised the influenza A(H1N1) alert to phase 6 (pandemic), the Association of Biological Manufacturers of Japan (ABMJ) authorized members (Kitasato Kenkyujo, Kaketsuken, Biken and Denka Seiyaku) are ready starting July to produce 25 million doses for the autumn anti new-flu vaccination campaign ... Vaccines in JAD Databases
●June 12, 2009: JKS News: The Society of the Japanese Pharmacopoeia (SJP) and the Japan Pharmaceutical Manufacturers Association (JPMA)   jointly held the "ICH Japan Symposium 2009" (the regular SJP's 20th ICH Immediate Briefing) in Tokyo closely following the ICH Yokohama Steering Committee / Expert Working Groups Meeting (June 6-11, 2009) with M2 (eCTD New Major version) issues highlighted ... Information Meetings reports
●June 11, 2009: Product News: Nineteen new products from 9 categories obtained reimbursement price for National Drug Tariff List as drugs for treatment of ADHD, cancer, diabetes ...
Reimbursement consulting |
Report preview
●June 10, 2009: JKS News: The Economic Affairs Division of the Health Policy Bureau (HPB) and Evaluation and Licensing Division (ELD) of the Pharmaceutical and Food Safety Bureau (PFSB) of MHLW jointly issued a Notification clarifying patent issues in approval of generic products ... Generics report preview
●June 9, 2009: JKS News: Ando Shoken KK   , Daiwa Shoken SMBC KK   and other equity houses soliciting investors in Japan for the "Vaccine Bonds" issued by the International Finance Facility for Immunisation Company (IFFIm)   and the GAVI Alliance   ... Vaccine report preview
●June 8, 2009: JKS News: The "Center for Development of Unapproved Drugs" established by the Japan Pharmaceutical Manufacturers Association (JPMA) to be headed by "top officials" from The Japanese Association of Medical Sciences (JAMS), comprising 107 medical learned
societies in Japan ... Unapproved drugs report preview
●June 5, 2009: Japanese mobile communication providers respond to the Government-initiated pilot testing of the GPS-equipped cellular phone use in tracking the spread of influenza epidemic in Japan, having the highest number of casualties outside US ... Epidemiology consulting | E-health research site
●June 4, 2009: JKS News: The Japan Society of Hepatology   makes available for public comments the final draft of "Guideline for Liver Cancer Diagnosis and Treatment" ... Liver cancer in Japan consulting | Anti-cancers in Japan reports
●June 3, 2009: JKS News: The Central Social Insurance Medical Council (CSIMC)   held a discussion on prices for generics and drugs with prices under special provisions ("exempt drugs") ...
Drug price services | Report preview
●June 2, 2009: JKS News: The Intellectual Property Strategy Headquarters   to allow patenting of dosing methods for pharmaceuticals ... Patented medicines consulting
●June 1, 2009: JKS News: OTC drugs sales deregulation enter into effect for any physical retailer capable to provide a specially-trained sales staff; efforts of Japanese internet retailers led by Rakuten   to deregulate also the online malls failed ... Japanese pharma laws consulting
●May 27, 2009: JKS News: The Non-prescription Subcommittee of PAFSC, MHLW recommended for the first time a Vidarabine-based product for OTC sale: Sato Seiyaku ointment for self-medication of herpes labialis ... OTC switch products in JAD Databases | Relevant report
●May 25, 2009: JKS News: Shionogi Seiyaku KK   project a 2010 market launch of anti-flu drug Peramivir (neuraminidase inhibitor), discovered by BioCryst Pharmaceuticals, Inc.   pending the successful completion of Phase III Asian Multinational Study (Outpatients Flu/Seasonal influenza, i.v.); Shionogi price rose sharply on Tokyo Stock Exchange (TSE) to rank among top ten performing stocks ...
Shionogi products in JAD Databases
●May 22, 2009: JKS News: The MHLW - hold a round table on "Improvement of Ethical Drugs Distribution" concluded that after the 2008 price cut 98% price disparity (invoiced vs. sales prices) still exists ... P&R consulting services | Pricing & Reimbursement in Japan report preview
●May 21, 2009: JKS News: The Economic Affairs Division, Health Policy Bureau, MHLW issued a guidance to pharma manufacturers to address the growing concerns about unstable supply of generic products ... Generics report preview
●May 19, 2009: JKS News: Japanese majors in specialty pharma acquisition mode: Takeda Yakuhin Kogyo KK   tender offering for IMD Pharma Inc.   to strengthen its own anti-cancer pipeline; Shionogi Seiyaku KK purchased Victory Pharma Inc.   for its pain-management products ... Takeda and Shionogi products in JAD Databases
●May 18, 2009: JKS News: Yakult Honsha KK   reports higher profit, unaffected by new generic competition to its main oncology drug ... Yakult Honsha products in JAD Databases | Anti-cancers in Japan reports
●May 15, 2009: JKS News: The MHLW approved 318 new formulations of generics manufactured by 54 different makers after patent expirations of key anti-hypertensive, anti-bacterial and anti-cancer drugs ... Patented medicines details in JAD Database
●May 14, 2009: JKS News: The gigantic Ministry of Health, Labor and Welfare (MHLW) under consideration to be split again into two newly "reinforced" entities ... Japanese Government
●May 13, 2009: PMDA News: The total number of Accredited Foreign Manufacturers to PMDA has reached 6,000 for three years ... Report preview
●May 12, 2009: JKS News: Bankrupted BearingPoint Commercial Services in Japan became newly
established PricewaterhouseCoopers Consultants KK   ; PwC re-enter the life science consulting ... related readings
●May 11, 2009: JKS News: The extremely positive results of PROVE 1 and PROVE 2 studies (Telaprevir with Peginterferon and Ribavirin for Chronic HCV) could considerably influence the development of Telaprevir in Japan carried out by Vertex Pharmaceuticals   in collaboration with Tanabe Mitsubishi Seiyaku KK   ... TM product details in JAD Databases
●May 8, 2009: JKS News: The 10th International HL7 Interoperability Conference 2009 IHIC 2009   opened in Kyoto ... E-health research
●May 7, 2009: JKS News: The FY 2009 Supplementary Budget to be approved by the Japan National Diet   contains 80 billion Yen allocated for new 6-months fast-track drugs review and approval procedure; MHLW to finalize the list of "Unapproved Medicinal Products" ... Report preview
●May 5, 2009: JKS News: The MHLW to fast-track the review and approval of 3 late stage anti-flu drugs developed by Fujifilm Holdings'   subsidiary Toyama Kagaku KK
  , Shionogi Seiyaku KK and Daiichi-Sankyo KK   with possible market launch as early as FY 2009 ... products under development details in JAD Database
●May 1, 2009: JKS News: Beleaguered Daiichi-Sankyo KK   expects to report 340 billion Yen loss for FY 2008 following the acquisition of the ever-shrinking stock of Ranbaxy Laboratories Ltd (RLL)   ... related readings
●April 27, 2009: JKS News: Amidst anxiety of swine flu, Chugai Seiyaku KK reports double Q1 profit, earnings and 19% shares rise, however, the newest 10,000-case MHLW study found patients aged 10 to 17 were 54% more likely to exhibit abnormal behavior due to Tamiflu treatment ... Chugai products in JAD Databases | previous comments
●April 23, 2009: The Minister of MHLW
approved 14 new products and formulations ... details in JAD Database
●April 22, 2009: JKS News: The Head of the Economic Affairs Division, Health Policy Bureau, MHLW Mr. Satoshi Kinoshita   , speaking at Japan Society of Generic Medicines Seminar included in CPhI Japan 2009   delivered a lecture "National Efforts in Spreading use of Generics", commented on "7-point rule" and promised a price support for orphan, anticancer, HIV and unapproved drugs ... Consulting services | Pricing & Reimbursement in Japan report preview
●April 21, 2009: JKS News: The FY 2009 Supplementary Budget to include 80 billion Yen in support for development of about 50 unapproved drugs with emphasis on cancer, pediatric formulations; in a private initiative The Japan Pharmaceutical Manufacturers Association (JPMA) to establish a "Center for Development of Unapproved Drugs" ... Anti-cancers in JAD Databases |
Anti-cancers in Japan reports | Unapproved drugs report preview
●April 20, 2009: JKS News: The newly started Meiji Holdings KK   aims to 20% expansion of pharmaceutical business of the group members Meiji Seika Kaisha KK, Meiji Nyugyo KK and Solvay Meiji Yakuhin KK ... Meiji products in JAD Databases | market consulting | related reading
●April 16, 2009: JKS News: The first for 2009 Drugs and Medical Devices Safety Update Seminar held in Tokyo, "Pharmaceutical Risk Management and Current Status of Japan's Medical Treatment Databases" one of the key topics ... Preceding safety meetings reports
●April 15, 2009: QUICK Consensus poll run by Nihon Keizai Shimbun for the 30 top performing TSE listed stocks ranks six pharma and healthcare related companies: Takeda Yakuhin Kogyo KK (1st), Santen Seiyaku KK (5th), Shionogi KK (6th), Tsumura KK (18th), So-net M3 (20th) and Kyorin KK (21) ... approved products in JAD Databases
●April 14, 2009: JKS News: In a commissioned study the Office of Pharmaceutical Industry Research (OPIR) to the Japan Pharmaceutical Manufacturers Association (JPMA) found that in FY2008, the average PMDA review time has been reduced to 19 months ... PMDA consulting services | "Drug lag" report preview
●April 13, 2009: JKS News: Nobel Pharma KK   obtained the development and sales rights in Japan for the Government-designated unapproved drug anti-glioma Gliadel Wafer (polifeprosan 20 with carmustine implant) from Eisai KK   following the latter's acquisition of MGI Pharma   , the owner of the original Gliadel developer Guilford Pharmaceuticals ...
Eisai / MGI news coverage | Nobelpharma products in JAD Databases
●April 8, 2009: JKS News: Nihon Chouzai KK   initiated "Generic drug inquiry service" aimed to provide Rx-to-generics switch option at all of its stores ... Generics report preview
●April 7, 2009: JKS News: The first ever medical device exhibition Medtec Japan 2009   opened in Yokohama ...
●April 7, 2009: JKS News: The local subsidiaries of Johnson & Johnson, Abbot Laboratories, Edwards Lifesciences and 59 other US medical device makers formed a pressure group - American Medical Devices and Diagnostics Manufacturer's Association (AMDD) to lobby the Japanese authorities for speedier device approval ... Medical devices / IVD consulting
●April 6, 2009: 90% of insomnia specialists surveyed by the Japan Health Sciences Foundation (JHSF)   believe the rate of all four types of related disorders (sleeplessness, sleep apnea syndrome, circadian rhythm sleep disorder and the restless leg syndrome) will significantly increase due to the current socio-economic situation ...
Insomnia concept report | Market assessment
●April 2, 2009: Nippon Medtronic KK received marketing authorization for Endeavor   - the first cobalt alloy based drug-eluting stent (DES) to be launched in Japan ... Medical device consulting | Related reports
●April 1, 2009: JKS News: The Fiscal 2009 Years starts in Japan, OTC pharmas most busy in readying for the sales deregulation ... Japanese pharma laws consulting
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