●March 31, 2009: JKS News: The Committee of Drugs of PAFSC, MHLW   pre-approved Clozapine of Novartis Pharma KK   , 13 other products ... Details in JAD Databases
●March 30, 2009: JKS News: Chugai Seiyaku KK   has achieved largest share (15.8%) in Japan anticancer market ... Roche/Chugai products in JAD Databases | related readings
●March 27, 2009: PMDA: Pharmaceuticals and Medical Devices Safety Information Bulletin No. 256   released, Atarax (Hydroxyzine pamoate) adverse events summarized ... Pfizer products in JAD Databases | Epidemiology of allergy consulting
●March 26, 2009: JKS News: Two group companies of Mitsubishi Chemical Holdings KK - the Tanabe-Mitsubishi Seiyaku KK   manufacturer of Medway Injections (human serum albumin genetical recombination), and the sales promoter Benesis KK   started a product recall and requested revocation of the approval due to questionable pre-clinical data and validation issues ... TM product details in JAD Databases
●March 26, 2009: JKS News: The Medical Treatment Fee Basic Problems Subcommittee to the Central Social Insurance Medical Council (CSIMC)   published an overview report detailing the actual increased use of generics in FY 2008 ... Generics report preview
●March 25, 2009: JKS News: The Japan Health Sciences Foundation (JHSF)   completed the 2008 update of the "Research and Development Strategy in the Era of Global Development: New Approaches in Drug Discovery and Pipeline Creation" report comparing 19 EU and US major pharmas, top ranking Novartis ...
Novartis pipeline in JAD Database
●March 24, 2009: PMDA   announced improvement of the NDA review procedures, CTD handling, PMDA
consultations from April 1 ... eCTD & dossier support services
●March 23, 2009: JKS News: The four group companies of Bristol-Myers Squibb Company (BMS)   in Japan: Bristol Seiyaku YK (BPYK), Bristol-Myers KK (BMKK), Bristol-Myers Squibb YK (BMSYK) and Mead Johnson KK (MJKK) to embark on major expansion of the sales force to reach 760 medical representatives within 3 years for a range of new drugs ... BMS products in JAD Databases
●March 22, 2009: Daiichi-Sankyo KK   filled for patent infringement of Cravit (Levofloxacin hydrate) against 13 generics makers: Shiono Chemical KK, Taiyo Yakuhin KK, Takata Seiyaku KK, Nichi-Iko Seiyaku KK, Nihon Generic KK, Mylan Seiyaku KK, and Yoshindo KK, Ohara Seiyaku KK, Sawai Yakuhin KK, Taisho Seiyaku KK, Choseido Seiyaku KK, Towa Yakuhin KK and Nipro Pharma KK ... Daiichi-Sankyo products in JAD Databases
●March 20, 2009: JKS News: MHLW extrapolates 37,800 nation-wide juvenile dementia (under 65 y.o.) patients ...
Epidemiology consulting
●March 19, 2009: JKS News: MHLW decided to re-start with a newly developed product the routine vaccinations against Japanese encephalitis discontinued in 2006 after a series of acute disseminated encephalomyelitis cases ... Vaccines in JAD Databases |
Relevant report
March 18, 2009: The World Intellectual Property Organization (WIPO)
  reported a record number of cybersquatting cases in 2008, as biotechnology and pharmaceutical corporate and product domains are most frequently (10%) infringed ... Pharma IP consulting
●March 17, 2009: JKS News: Pharmaceuticals and Food Safety Bureau (PFSB) of MHLW revises the key notification on "Specifications on the Range of Drugs" to include provisions for bio-similars (bio follow-on drugs) ...
●March 16, 2009: Nihon Keizai Shimbun: In the annual closing of the fiscal year ranking on liquidity the pharma companies Dainippon Sumitomo Seiyaku KK   and specialty drug developer Seikagaku KK   took 9th and 23rd places among the TSE listed Japanese companies with market cap over 50 billion Yen Dainippon Sumitomo products in JAD Databases
●March 13, 2009: JKS News: Gilead Sciences   outbid the hostile offer for CV Therapeutics; Astellas Seiyaku KK   - 6% stock owner and plaintiff against CVT still has the option to increase the offer... Gilead products in JAD Databases
●March 12, 2009: The World Kidney Day   to be observed in Japan today... Kidney disease market in Japan
●March 11, 2009: JKS News: After the approval of Cinacalcet for secondary hyperparathyroidism Kyowa Hakko Kirin KK
 
submits for extended indications of renal anemia drug for treatment of pre-dialysis patients aiming to increase its overall share in the kidney failure market ... Kyowa Hakko Kirin products in JAD Databases
●March 10, 2009: JKS News: Astellas Seiyaku KK plans to dispose the entire board of CV Therapeutics   including the Founder and perennial Chairman cum CEO Dr. Louis G. Lange   ... Astellas products in JAD Databases
●March 9, 2009: Merck to reverse-merger with Schering-Plough, expects regulatory approvals in Japan from where projects 6% share (3 billion US$) of the combined global sales ... Banyu (Merck) and Schering-Plough products in JAD Databases
●March 6, 2009: Shionogi Seiyaku KK   launched a public awareness campaign on Chronic Kidney Disease (CKD) ... Epidemiology of CKD
●March 4, 2009: JKS News: If approved the re-introduced "Pharmaceutical Market Access and Drug Safety Act would provide for importation of FDA-endorsed medications from Japan ... Pricing and Reimbursement (P&R) consulting
●March 3, 2009: PMDA starts to accept applications for consultations in April for bioventures in the fields of regenerative medicine, preventive vaccines, gene therapy and innovative medical devices ... Consulting services
●March 2, 2009: JKS News: MHLW approved dry cell culture vaccine for Japanese encephalitis developed by BIKEN (Osaka University Research Institute for Microbial Diseases)   ... Unapproved therapies report preview
●February 28, 2009: JKS News: Astellas Seiyaku KK launched yet another hostile bid for all shares of CV Therapeutics ... Astellas products in JAD Databases | Unapproved prospective products preview
●February 27, 2009: JKS News: Eisai KK   to re-organize its 2,000-strong R&D force into 13 units across international borders under a new E-Pharma" management model; all researchers from the acquired MGI Pharma   to join the oncology unit ... Previous coverage | Related readings
●February 26, 2009: Schering-Plough KK   re-launched a Hepatitis C dedicated web site (C-KAN NET) targeting both patients and physicians ... Schering-Plough products in JAD Databases | Interferon consulting
●February 23, 2009: The annual survey of Nihon Keizai Shimbun
  ranks Eisai KK as No. 1 and the most defensive stock in terms of steady return of dividends; five out of the 10 top stops occupied by pharmas ... Eisai products in JAD Databases
●February 20, 2009: JKS News: The European subsidiary of Eisai KK   obtained EU marketing rights for still unapproved anti-epileptic drug Zebinix (eslicarbazepine acetate) from Bial-Portela & Ca. SA   against 11 billion Yen ... previous Eisai acquisition news coverage
●February 17, 2009: PMDA held the "PMDA Third International Symposium on Biologics", with keynote
speech on "Current status of Japanese Regulation and Development on Biologics" ...
related resources
●February 16, 2009: JKS News: Teva KK   - a subsidiary of Teva Pharmaceutical Industries Ltd. and the unlisted Kowa KK   - announced a plan through their JV Teva-Kowa Pharma KK to introduce about 300 generic products by 2015. All major Japanese generics makers are expected to report higher profit for FY 2008 ... Teva Master Files and Kowa products in JAD Databases | Generics report preview
●February 12, 2009: JKS News: The Economic Affairs Division, Health Policy Bureau, MHLW announced that as a result of "Public-Private Dialogue for Drug Discovery and Innovation" initiative will be set forth to focus on regenerative medicine, including private cell culture banks and to clarify the legal status ... Unapproved therapies report preview
●February 6, 2009: JKS News: The major vaccine producer Kaketsuken Foundation   tied up with for GlaxoSmithKline Japan KK   and GSK Biologicals to develop pandemic anti-flu vaccine ... Vaccines in JAD Databases | Vaccine report preview
●February 5, 2009: JKS News: Astellas Seiyaku KK announced organizational changes in global development; reshuffling of top corporate management, financial, legal and strategy executives to be implemented effective April 1 ... Astellas products in JAD Databases
●February 3, 2009: JKS News: The Office of Pharmaceutical Industry Research (OPIR) to the Japan Pharmaceutical Manufacturers Association (JPMA)   released the Research Paper No. 44 "Survey of Pharmaceutical Companies about the Economic Evaluation of Drugs" ... JAD consulting services | Pricing & Reimbursement report preview
●February 2, 2009: The The FDA staff quoted (Reuters) the agency would conditionally approve Prasugrel discovered by Ube Kousan KK   , developed by Daiichi-Sankyo KK and scheduled for co-marketing with Eli Lilly   as Effient ... Ube Kousan, Nippon Eli Lilly and Daiichi-Sankyo products in JAD Databases
●January 29-30, 2009: JKS News: The First and Second Subcommittees of Drugs of PAFSC, MHLW recommended for approval anti AHDH drug; positively review orphan drug ... Orphan drugs (ODD) in JAD Databases | Report preview
●January 29, 2009: JKS News: After a decade of peaceful collaboration Astellas Seiyaku KK made public its second hostile bid for all shares of CV Therapeutics ; the CVT board responds with 1-year extension of anti-takeover measures ... Astellas products in JAD Databases | Unapproved prospective products preview
●January 27, 2009: JKS News: The fourth-ranked Pfizer KK launched 55th Anniversary PR campaign   prepares for integration of 1,000-strong Wyeth KK   ... previous Pfizer news | Pfizer and Wyeth products in JAD Databases
●January 26, 2009: JKS News: Daiwa Shoken SMBC KK   , a leading equity house to start offering in Japan the issued by the International Finance Facility for Immunisation Company (IFFIm)   and the GAVI Alliance   "vaccine bonds" ... Vaccine report preview
●January 21, 2009: The Minister of MHLW
approved 18 new products and formulations, Novartis Pharma KK has a record 4 new approvals ... full details in JAD Database
●January 20, 2009: JKS News: Ten years after Nippon Roche KK   failure with Orlistat registration Taisho Seiyaku KK   obtained a license from Glaxo Group Ltd (UK) for OTC development in Japan thus targeting the multimillion obese population ... Disease epidemiology consulting and data
●January 19, 2009: JKS News: In a rare litigation case Teijin Pharma KK   is suing a smaller generic rival Towa Yakuhin KK   over package imitation   of Beclometasone dipropionate decongestant nasal spray... Teijin and Towa products in JAD Databases | Competitive consulting
●January 15, 2009: JKS News: Unmet Medical Needs Pharma KK (UMN Pharma)   announced that the in-licensed in 2006 from Protein Sciences Corp.   FluBlok anti-H5N1 recombinant influenza vaccine was successful in the 125-subjects Japan Phase I trial ... product details in JAD Databases | Vaccine report preview |
related readings
●January 14, 2009: JKS News: MHLW 2007 "National Health and Nutrition Examination Survey" found 29% of population at risk of diabetes, over 40s particularly affected ... Epidemiology consulting and data
●January 13, 2009: JKS News: Dr. Taro Tsukahara, a graduate of Jichi Medical University   assumed the position of MHLW Secretariat Counselor in charge of pharmaceuticals and food ... related laws
●January 9, 2009: Wholesalers dynamics: Due to competitive reasons the largest drug wholesaler Mediceo Paltac Holdings KK   and No. 2 Alfresa Holdings KK   scrapped the planned 4 trillion Yen merger; the fourth-largest wholesaler Toho Yakuhin KK   to acquire mid-size Hiroshima-based Omwell KK   ... Consulting services | Pricing & Reimbursement in Japan report preview
●January 6, 2009: JKS News: Daiichi-Sankyo KK   announced a non-cash valuation loss of 359.5 billion Yen on its shares and one-time write-down of goodwill on its investment in Ranbaxy Laboratories Ltd (RLL)   reflecting the more than 50% decline in the market value of RLL securities versus the purchase price with anticipated significant negative impact on net income, but not on shareholders dividends for the FY 2008 ... Daiichi Sankyo products in JAD Databases
●January 5, 2009: JKS News: In 2009 the Japanese pharmaceutical industries unscathed by the global financial crisis reorienting toward BRIC (Brazil, Russia, India and China) countries and other emerging markets ... Key reading
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