●December 31, 2008: The Prasugrel co-developers Eli Lilly   and Daiichi-Sankyo KK   announced that critical FDA meeting regarding US approval is scheduled for February 3rd, 2009 ... Nippon Eli Lilly and Daiichi-Sankyo products in JAD Databases
●December 17, 2008: M&A News: Mid-tier generics Daiso Chemical KK   , acquires bulk manufacturer Sanyo Fine KK   to expand into pharmaceutical intermediates space ...
Generic and API products in JAD Databases | report preview
●December 16, 2008: JKS News: Ministry of Education, Culture, Sports, Science and Technology (MEXT)   survey found asthma in 2.7% of
kindergarten pupils ... Epidemiology consulting and data
December 12, 2008: Product News: Pirespa (Pirfenidone) obtained reimbursement price for National Drug Tariff List; Shionogi Seiyaku KK   started the market launch ...
Shionogi products in JAD Databases |
Reimbursement consulting |
Report preview
●December 10, 2008: Healthcare-oriented Social Democratic Party (SDP)   opposed sale of OTC products over Internet ...
OTC products consulting | e-health research site
●December 5, 2008: The Japan Generic Pharmaceutical Manufacturers Association (JGPMA)   announced that the sales of generics for member companies for FY 2007 increased only with a single digit (5.6%) ...
Generic products in JAD Databases | report preview
●December 4, 2008: Fukuoka-based Kurume University Hospital
  to pioneer in 2009 the first in Japan center for non-reimbursable autologous cancer vaccination ...
Reimbursement consulting |
Report preview
●December 3, 2008: JKS News: MHLW   survey found measles vaccination rate still low at 50% ...
Vaccines in JAD Databases |
Relevant report
●December 2, 2008: PMDA   announced: 1) reorganization of the Office of New Drug III to handle exclusively central and peripheral nervous systems, sensory organ drugs, narcotics; 2) changed the rules for clinical trial
consultations to be enforced on April 2009 ...
CNS products in JAD Databases |
PMDA consulting | related laws
●December 1, 2008: Medical device maker Mani KK selected as recipient of the annual Porter Prize 2008   bestowed in Japan for excellence in management practice, innovation and profitability ...
Medical device consulting
●November 28, 2008: JKS News: The First Subcommittee of Drugs of PAFSC, MHLW recommended for approval novel treatment for age-related macular degeneration syndrome; positively review newest orphan drug designations ... Orphan drugs (ODD) in JAD Databases | Report preview
●November 27, 2008: JKS News: The Second Subcommittee of Drugs of PAFSC, MHLW recommended for approval anti-HIV, anti-CML drugs, other products ... Submitted products in JAD Databases
●November 26, 2008: JKS News: The Non-prescription Subcommittee of PAFSC, MHLW recommended for OTC switch two products for treatment of vaginal candidiases ... OTC switch products in JAD Databases | Relevant report
●November 25, 2008: Nippon Eli Lilly KK reported the outcome of 2008 family survey: 70% of women unsatisfied with ED awareness of their partners ... Related report preview | Key reading
●November 21, 2008: Mid-tier generics manufacturer Nippon Chemical Research KK (JCR Pharmaceuticals)   , affiliated with Kissei Seiyaku KK   jointly submitted for approval an off-patent version of genetically modified human erythropoietin (EPO) as the first ever biogeneric product in Japan ...
JCR & Kissei products in JAD Databases | report preview
November 20, 2008: MHLW personnel on a high security alert   after multiple terrorist attacks on former vice ministers; the official functions, including of the Pharmaceuticals and Food Safety Bureau (PFSB) not disrupted
November 19, 2008: Astellas Seiyaku KK   triple news: established Astellas Pharma India Private Limited in Mumbai, India; obtained approval for participation in iPS project designated as "Advanced Medical Care Special Development Domain"; received favorable recommendation from the Anti-Infective Drugs Advisory Committee (AIDAC) of FDA for injectable antibiotic telavancin, licensed-in from Theravance, Inc. ... Astellas products in JAD Databases
November 18, 2008: Ms. Seiko Noda   , the State Minister in charge of Consumer Affairs, Food Safety, Science and Technology announced that Government shall provide financing and deregulation support for 24 "super" projects each designated as "Advanced Medical Care Special Development Domain" ... related readings
November 17, 2008: JKS News: MHLW granted orphan status of an anti-myelodysplastic syndrome product (OD designation No. 217) ... Orphan drug details in JAD Databases | ODD report preview
November 12, 2008: Mid-size generics maker Aska Seiyaku KK   and Iceland-based Actavis Group PTC ehf   to established 55:45 shared Aska Actavis Seiyaku KK in Tokyo in 2009 for manufacturing and sales of generics from 2010 ... Aska products in JAD Databases | report preview
November 11, 2008: PMDA announced the creation of the "International Business Promotion Strategic Head Department" led by Dr. Satoshi Toyoshima   , PMDA Executive Director and Director of the Center for Product Evaluation to improve the international collaboration ... related laws
November 10, 2008: M&A research provider Recof KK  survey: the value of Japanese M&A during Jan-Oct period increased 3.7 times compared to 2007 ... related readings
November 9, 2008: World Health Organization (WHO) Congress on Traditional Medicine held in Beijing recognized the importance and therapeutic value of folk remedies used in Japan ... TM products in JAD Databases
November 7, 2008: JKS News: Daiichi-Sankyo KK   finalized the acquisition of Ranbaxy Laboratories Ltd (RLL)   thus becoming the world 15th largest pharma company ... Daiichi Sankyo products in JAD Databases
November 6, 2008: Mr. Isao Teshirogi
  , President of Shionogi Seiyaku KK   quoted as predicting size reduction of US pharma market as consequence of election results ... Market consulting
October 31, 2008: JKS News: Sanofi-aventis KK   to start dissolving pre-deregulation era pharma joint ventures, starting with Laboratoires Daiichi Sanofi-aventis and Sanofi-aventis Daiichi Seiyaku KK, established in 1989 for anti-thrombotic treatment; other JV   may follow ... Sanofi in JAD Databases
October 30, 2008: Fukushima Medical University Hospital
  reported to accept patients donations to bypass the ban on mixed insurance payment for high-expense treatment; the case likely to result in review of the regulations ... Reimbursement consulting | Report preview
October 28, 2008: Novartis AG Chairman and CEO Daniel Vasella
  told the 10th Nikkei Global Management Forum in Tokyo that the company has enough "innovation and brainpower" for robust drug development ... Novartis products in JAD Databases
October 23, 2008: Dainippon Sumitomo Seiyaku KK
  ranked 7th among listed Japanese companies in term of R&D spending announced the establishment of Neuropsychiatry Drug Discovery Consortium (NDDC) with Osaka University ... Dainippon Sumitomo products in JAD Databases | Depression report preview
October 23, 2008: JKS News: The Japan Pharmacies Association (NPhA) survey: the number of generics stocked in members pharmacies handling insured drugs has increased 1.5 times since 2007 ... Generics report preview
October 21, 2008: JKS News: The Society of the Japanese Pharmacopoeia (SJP) organized the 27th New Drug Evaluation Division Information Meeting in Tokyo with major topics on GMP, next 5-year approval review time plans, safety of biotech products ... Information Meetings reports
October 21, 2008: JKS News: The Office of Pharmaceutical Industry Research (OPIR) to the Japan Pharmaceutical Manufacturers Association (JPMA)   released the Research Paper No. 42 "Timeline for Development of New Drugs in Japan: Clinical Development and Approval Examination Timelines" ... JAD consulting services | report preview
October 20, 2008: JKS News: Daiichi-Sankyo KK announced the acquisition of 52.5% of the stock and transformation of Ranbaxy Laboratories Ltd (RLL) into subsidiary ... Daiichi Sankyo products in JAD Databases
October 16, 2008: JKS News: The orphan drug Pirespa (Pirfenidone) developed by Intermune (licensed-in from Marnac Inc and KDL GmbH)   and submitted in Japan by Shionogi Seiyaku KK received its worldwide first approval as treatment for idiopathic pulmonary fibrosis (PF); ELD, PFSB issued a PRECAUTIONS warning ... Orphan and Submitted products in JAD Databases
October 16, 2008: The Minister of MHLW
approved 33 new products and formulations, including orphan drugs ... details in JAD Database
October 16, 2008: JKS News: Progenics Pharmaceuticals, Inc.   licensed-out to Ono Seiyaku KK   development rights in Japan for methylnaltrexone bromide (MNTX) for the treatment of opioid-induced constipation ...related reading
October 15, 2008: JKS News: Bayer AG   decided to delist from the foreign section of the Tokyo Stock Exchange (TSE)   "low turnover" cited ... related readings
October 15, 2008: JKS News: The Japan Pharmaceutical Manufacturers Association (JPMA) appointed Mr. Shin Kawabe   , a former MHLW official as new Managing Director of the association ...
October 13, 2008: JKS News: Following financial downturn on the Tokyo Stock Exchange (TSE) the market capitalization of Eisai KK   felt below 1 trillion Yen threshold ...
previous Eisai news coverage | related readings
October 11, 2008: JKS News: The MHLW 2007 survey on corporation penetration of mental health measures: only 33% (10% up) of poled firms have any policies at place ... Consulting services |
Psychiatry report preview
October 10, 2008: JKS News: The two largest members of the Federation of Japan Pharmaceutical Wholesalers Associations (JPWA)   - Mediceo Paltac Holdings KK   and Alfresa Holdings KK   to merge into 4 trillion Yen pharma wholesales market leader ... Consulting services | Pricing & Reimbursement in Japan report preview
October 8, 2008: JKS News: Mr. Takashi Shoda   , the President of Daiichi-Sankyo KK warned about possible valuation loss due to sharp decrease of acquired Ranbaxy Laboratories Ltd (RLL) stock price ... Daiichi Sankyo products in JAD Databases | report preview
October 7, 2008: JKS News: PMDA
invites qualified opinions for sixteen new articles to be included in the Japanese Pharmacopoeia XVI Editions due in 2011 ... Information Meetings reports
October 3, 2008: The Pharmaceutical Affairs Committee of the PAFSC, MHLW
recommended for pending approval thalidomide for multiple sclerosis, other ten prescription and one OTC new products ... details in JAD Database
October 1, 2008: JKS News: The newest pharma company Kyowa Hakko Kirin KK
 
inaugurated with focus on "bio" ... previous news | related reading
October 1, 2007: JKS News: Breast Cancer Awareness Campaign months starts   Tokyo Tower and and other contemporary landmarks illuminated in pink Cancer epidemiology consulting and data
October 1, 2008: JKS News: The Economic Affairs Division, Health Policy Bureau, MHLW set up "Generic Drugs Use Promotion Office", the ex-PMDA Mr. A. Shibukawa appointed as Head ... Generics in Japan report preview
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