Jouhou Koukai News

Taking advantage of the strong Yen, the mid-sized Zeria Shinyaku Kogyo KK

Tue, 7 Sep 2010 15:38:29 +0900

continues the acquisition drive and product line expansion: after making Swiss-based Tillotts Pharma AG a wholly-owned subsidiary in 2009, in mid-September Zeria will buy its current Denmark-based Sodium chondroitin sulfates supplier Biofac A/S Esbjerg factory; announced entering into comprehensive and exclusive contract for domestic development and sales of hemostatic dressing and wound dressing products of Oregon-based HemCon Medical Technologies Inc. introducing to Japan its chitosan-containing medical devices

Daiichi-Sankyo news update: Daiichi-Sankyo KK sets up a vaccine JV with Kitasato Kenkyujo

Mon, 26 Jul 2010 13:39:49 +0900

to produce wide-range of vaccines, including anti-flu vaccines manufactured by cell culture technology; ● further realigns Ranbaxy collaboration: the new drug R&D to be consolidated in the new Daiichi Sankyo Life Science Research Center in Japan, as Ranbaxy to focus of generics; ● sales network of Ranbaxy in Eastern Europe and South Africa to be used for selling Daiichi-Sankyo products

The the highly contested general elections ended with complex political balance,

Mon, 12 Jul 2010 23:49:59 +0900

future of healthcare still unchartered

After the IHI Plant Engineering KK (of IHI Group) another major machinery manufacturer - Kawasaki Heavy Industries

Tue, 6 Jul 2010 15:31:46 +0900

by partnering with the National Center for Child Health and Development and the National Institute of Advanced Industrial Science and Technology (AIST) has entered the advanced biotech field in establishing a method for accelerating the stem cell culturing

Eisai KK announced: that has obtained two additional indications

Mon, 28 Jun 2010 11:44:55 +0900

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 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) Mr. Haruo Naito, President & CEO appeared to be the highest paid Japanese pharma executive with 136 million Yen compensation

Flu pandemic in Japan (update 11) - vaccines:

Thur, 24 Jun 2010 17:34:51 +0900

The UMN Pharma KK (Unmet Medical Needs Pharma) and its main corporate backer - thee IHI Plant Engineering KK (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 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

The MHLW announced that the Government will expand

Mon, 21 Jun 2010 11:14:25 +0900

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

The new Cabinet revealed the details of the finalized "New Growth Strategy (Basic Policies) Toward a Radiant Japan"

Fri, 18 Jun 2010 18:28:38 +0900

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

After obtaining reimbursement price of June 11, 2010 Alexion Pharma KK

Mon, 14 Jun 2010 10:14:24 +0900

announced the availability for Japanese patients of paroxysmal nocturnal hemoglobinuria (PNH) of Soliris (eculizumab) Solution for IV drip infusion 300 mg - a humanized monoclonal anti-complement (C5) inhibitor and first product in Japan for treatment of PNH

Mental health news: The Cultural Affairs Council

Thur, 10 Jun 2010 17:27:37 +0900

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" used in the term for psychological depression; the inaugurated in January "Suicide and Depression Preventive Measures" Project Team 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

The Japan Pharmaceutical Manufacturers Association (JPMA)

Tue, 8 Jun 2010 18:28:38 +0900

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

The MHLW controlled National Institute of Biomedical Innovation

Fri, 4 Jun 2010 15:15:15 +0900

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

Nichi-Iko / Sanofi-Aventis update (4): The new JV under the name Nichi-Iko sanofi-aventis KK

Tue, 1 Jun 2010 5:05:0 +0900

capitalized at 100 million Yen is slated to start in June; the President & CEO of sanofi-aventis KK Mr. Patrick Chocat - is to named also President & CEO of the new entity, initially to be based in the headquarters 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

Nichi-Iko / Sanofi-Aventis update (3): The new JV under the name Nichi-Iko sanofi-aventis KK

Mon, 31 May 2010 10:09:16 +0900

Nichi-Iko / Sanofi-Aventis update (2): On June 16, 2010 Nichi-Iko KK shall issue 4.442 billion Yen

Fri, 28 May 2010 20:18:32 +0900

worth of common shares to be purchased by sanofi-aventis KK 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 has indicated that the company would be willing to obtain larger stake in Nichi-Iko KK if invited

In conflicting reports, Dow Jones Japan cited Mr. Christopher Viehbacher,

Thur, 27 May 2010 19:38:48 +0900

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 reported that Sanofi-aventis KK 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

In its latest metamorphosis, OSI Pharmaceuticals Inc.

Tue, 18 May 2010 12:12:24 +0900

once a NCI/NIH academic spin-off and formerly Oncogene Science, Inc. to become a subsidiary of Astellas Seiyaku KK ; in Japan Astellas to inherit complex relations with Chugai Seiyaku KK - 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

Vaccines update: In Tochigi Prefecture, a group of elementary school female students

Mon, 17 May 2010 12:35:19 +0900

have been vaccinated with Cervarix, domestically developed by GlaxoSmithKline KK 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 and Kitasato Kenkyujo, the newly formed vaccine unit of Daiichi-Sankyo KK announced plans to launch measles-rubella combination vaccine in FY 2011 and first inactivated polio quadruple DPT-polio vaccine; the MHLW to hold the 5th Anti- New Influenza (N1H1) Measures General Meeting on May 19th

Daiichi-Sankyo KK to replace Mr. Takashi Shoda

Fri, 14 May 2010 17:34:51 +0900

who successfully led the company through the merger between Daiichi and Sankyo in 2005 with the current Executive Vice President Mr. 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

The Diet passed the amended National Health Insurance Law

Thur, 13 May 2010 16:32:48 +0900

to increase the income-proportional individual, corporate and public contributions aimed to ease the social support for over 75 yo elderly

The MHLW announced that the Government will subsidize

Mon, 10 May 2010 13:15:19 +0900

50% of the minimum amount of medical fee for one category of low-income individual under the age of 70

The Nippon Denki KK (NEC) to launch

Sat, 8 May 2010 16:48:56 +0900

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

Amidst the falling prices at the Tokyo Stock Exchange (TSE)

Fri, 7 May 2010 12:24:36 +0900

shares of Takeda Yakuhin Kogyo KK 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

The major daily Yomiuri Shimbun survey

Thur, 6 May 2010 20:34:56 +0900

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

April 30, 2010: Archived JKS News feeds for 2007-2010

Fri, 30 Apr 2010 11:12:13 +0900

are available here

The MHLW released the complete translation into Japanese,

Fri, 30 Apr 2010 11:11:22 +0900

including instructions for the implementation of the eCTD IWG Q&A Version1.18

Drugstore industry (Update 2):

Thur, 29 Apr 2010 16:51:12 +0900

All leading drugstore operators, including Aeon KK CSF Corporation KK in collaboration with Yakuji KK, the industry No. 2 Sugi Holdings KK; the industry No. 3 Cocokara Fine Holdings KK; 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

Alarmed by not decreasing below 30,000 per year number of suicides in Japan,

Mon, 26 Apr 2010 09:07:05 +0900

the MHLW plan to included from the FY 2011 a mandatory basic mental condition examination during the routine annual health checks

Iceland volcanic ash severely disrupted

Thur, 22 Apr 2010 19:55:23 +0900

air deliveries from Europe of Molybdenum 99 shipped weekly due to short half-life

In the spring round of approval the MHLW

Tue, 20 Apr 2010 10:53:23 +0900

approved 31 new products and formulations, including record 5 products in 9 formulations Takeda Yakuhin Kogyo KK 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

Flu pandemic in Japan (update 10) - first wrap-ups:

Sat, 17 Apr 2010 11:22:44 +0900

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 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

The Japan Medical Association (JMA)

Mon, 5 Apr 2010 20:22:32 +0900

- 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

The Medical Economics Division of the Health Insurance Division, MHLW announced the biannual price cut:

Thu, 1 Apr 2010 12:24:36 +0900

in 2010 round the average reduction of the official reimbursement prices for 15,455 products is 5.75%

PMDA to announce the results of bidding

Wed, 31 Mar 2010 11:02:18 +0900

for building and maintaining an intra-agency system for new drug application dossier reviewing and eCTD handling

GlaxoSmithKline PLC to purchase from Mitsui Busan Principal Investments KK

Fri, 26 Mar 2010 15:18:21 +0900

over 3 millions common shares of Nippon Chemical Research KK - a developer of enzyme-replacement therapies (ERT) and biosimilars thus gaining 25% control of the company

In a long time not seen pharma company IPO

Wed, 24 Mar 2010 19:18:17 +0900

the API maker Daito KK debuted in the second section of the Tokyo Stock Exchange (TSE), stock raised over the initial price

PMDA published an extensive report

Thur, 18 Mar 2010 12:14:16 +0900

on the agency's activities in the FY 2009 related to quasi-drug new requirements, approvals and review

Drugstore industry realignment: Two major drugstore operators to be delisted from the Tokyo Stock Exchange (TSE)

Tue, 16 Mar 2010 19:16:23 +0900

due to industry reshaping mergers and acquisitions: the leading leading retailer Aeon KK to obtain controlling 51% stake in CSF Corporation KK, plans to make it core for drugstore and cosmetics operations; Cocokara Fine Holdings KK to absorb Allied Hearts Holdings KK and form a new entity on October 1, 2010

Flu pandemic in Japan update (9) - epidemics abates:

Sat, 13 Mar 2010 10:37:02 +0900

The National Institute of Infectious Diseases (NIID) 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 announce that none of the Britain's GlaxoSmithKline PLC and only 150 of the Switzerland's Novartis AG - 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

Research findings cited by Nihon Keizai Shimbun

Thur, 11 Mar 2010 20:15:48 +0900

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

The MHLW in conjunction with the Drug Price Subcommittee

Mon, 08 Mar 2010 18:05:23 +0900

of the Central Social Insurance Medical Council (CSIMC) announced the plan for 10 years post-approval price protection for all patented drugs; orphan and other niche products are projected to benefit most

Tokyo Stock Exchange (TSE) announced the 2009 Listed Company Awards:

Sun, 07 Mar 2010 17:05:43 +0900

Kyowa Hakko Kirin KK granted the 15th Corporate Disclosure Award

Pharmaceuticals and Medical Devices Agency (PMDA) released

Thur, 04 Mar 2010 18:21:23 +0900

the updated Japan Drug Master Files listing of over 7,000 entries

Lunkbeck Japan to initiate two Phase III studies with new anti-depressants

Wed, 03 Mar 2010 11:15:43 +0900

Danish pharma company H Lundbeck A/S (CPH: LUN) and its R&D partner Japanese Takeda Pharmaceutical Company Ltd (TYO: 4502) said today they will start pivotal clinical phase III studies with two depression drugs. The candidate drugs Lu AA21004 andLu AA24530 will be studied in patients with major depressive disorder (MDD).

The programme on Lu AA21004, which is expected to start in the first half of 2010, will comprise four clinical phase III studies including about 2,000 patients in addition to a long-term extension study. The planned doses are 10 mg, 15 mg and 20 mg.

The clinical phase III studies with Lu AA24530 will start with four individual trials, including a long-term study and a relapse prevention study. About 2,000 patients are planned to be included investigating doses at 10 mg and 20 mg. Selected trials will include an active reference compound. The programme is due to begin by the end of 2010 and may also include future phase III studies to further investigate the compound’s benefit and risk profile.

Lu AA21004 is a 5-HT(3), 5-HT(7) and 5-HT(1B) receptor antagonist, 5HT(1A) receptor agonist and 5-HT transporter inhibitor.

In pre-clinical studies, Lu AA24530 has demonstrated activities as a multi-modal enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT(3) and 5-HT(2c) receptors.

Date: 3 March 2010 Data sourced from: Nordic Business Report

April 23, 2009: The Minister of MHLW approved 14 new products and formulations

Thur, 23 Mar 2009 10:12:18 +0900

in Q2 round of approvals

March 16, 2009: Nihon Keizai Shimbun: In the annual closing of the fiscal year ranking on liquidity

Mon, 16 Mar 2009 10:12:18 +0900

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

February 23, 2009: The annual survey of Nihon Keizai Shimbun ranks Eisai KK

Mon, 23 Feb 2009 11:15:45 +0900

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

February 20, 2009: The European subsidiary of Eisai KK obtained EU marketing rights

Fri, 20 Feb 2009 18:22:13 +0900

for still unapproved anti-epileptic drug Zebinix (eslicarbazepine acetate) from Bial-Portela & Ca. SA against 11 billion Yen

February 17, 2009: PMDA held the "PMDA Third International Symposium on Biologics",

Tue, 17 Feb 2009 09:10:11 +0900

with keynote speech on "Current status of Japanese Regulation and Development on Biologics"

February 16, 2009: Teva KK - a subsidiary of Teva Pharmaceutical Industries Ltd.

Mon, 16 Feb 2009 19:53:23 +0900

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

February 12, 2009: The Economic Affairs Division, Health Policy Bureau, MHLW

Thu, 12 Feb 2009 11:12:23 +0900

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

February 6, 2009: The major vaccine producer Kaketsuken Foundation

Fri, 6 Feb 2009 14:33:25 +0900

tied up with for GlaxoSmithKline Japan KK and GSK Biologicals to develop pandemic anti-flu vaccine

February 5, 2009: Astellas Seiyaku KK announced organizational changes

Thu, 5 Feb 2009 12:31:43 +0900

in global development; reshuffling of top corporate management, financial, legal and strategy executives to be implemented effective April 1

February 3, 2009: The Office of Pharmaceutical Industry Research (OPIR)

Tue, 3 Feb 2009 15:58:18 +0900

to the Japan Pharmaceutical Manufacturers Association (JPMA) released the Research Paper No. 44 "Survey of Pharmaceutical Companies about the Economic Evaluation of Drugs"

February 2, 2009: The The FDA staff quoted (Reuters) the agency would conditionally approve Prasugrel

Tue, 3 Feb 2009 15:55:12 +0900

discovered by Ube Kousan KK, developed by Daiichi-Sankyo KK and scheduled for co-marketing with Eli Lilly as Effient

January 30, 2009: The First and Second Subcommittees of Drugs of PAFSC, MHLW recommended for approval

Fri, 30 Jan 2009 16:23:45 +0900

anti AHDH drug; positively review orphan drug

January 29, 2009: After a decade of peaceful collaboration Astellas Seiyaku KK

Thu, 29 Jan 2009 19:05:11 +0900

made public its second hostile bid for all shares of CV Therapeutics; the CVT board responds with 1-year extension of anti-takeover measures

January 27, 2009: The fourth-ranked Pfizer KK launched 55th Anniversary PR campaign,

Tue, 27 Jan 2009 10:03:05 +0900

prepares for integration of 1,000-strong Wyeth KK

January 26, 2009: Daiwa Shoken SMBC KK, a leading equity house to start offering in Japan

Mon, 26 Jan 2009 20:25:33 +0900

the issued by the International Finance Facility for Immunisation Company (IFFIm) and the GAVI Alliance "vaccine bonds"

January 21, 2009: The Minister of MHLW approved 18 new products and formulations,

Thu, 22 Jan 2009 13:05:47 +0900

Novartis Pharma KK has a record 4 new approvals

January 20, 2009: Ten years after Nippon Roche KK failure with Orlistat registration

Tue, 20 Jan 2009 09:35:08 +0900

Taisho Seiyaku KK obtained a license from Glaxo Group Ltd (UK) for OTC development in Japan thus targeting the multimillion obese population

January 19, 2009: In a rare litigation case Teijin Pharma KK

Sun, 18 Jan 2009 15:28:23 +0900

is suing a smaller generic rival Towa Yakuhin KK over package imitation of Beclometasone dipropionate decongestant nasal spray

January 15, 2009: Unmet Medical Needs Pharma KK (UMN Pharma) announced

Thu, 15 Jan 2009 17:18:19 +0900

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
UMN Press Release

UMN Pharma Confirms Immunogenicity and Safety of UMN-0501 Pandemic Influenza Vaccine in Phase I/II Clinical Trials.

Phase I/II clinical trials of UMN-0501, a new pandemic influenza vaccine manufactured from cell culture, were launched in June of 2008. Study results confirmed that UMN-0501 provided immunogenicity in the group administered vaccine without alum against a natural strain of pandemic influenza virus. The tolerability of UMN-0501 was good with no serious or highly adverse side effects diagnosed by the principal investigator. These results will be released at 5th WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials in February of 2009.

January 14, 2009: MHLW 2007 "National Health and Nutrition Examination Survey"

Wed, 14 Jan 2009 20:48:35 +0900

found 29% of population at risk of diabetes, over 40s particularly affected

January 13, 2009: Dr. Taro Tsukahara, a graduate of Jichi Medical University

Tue, 13 Jan 2009 12:38:00 +0900

assumed the position of MHLW Secretariat Counselor in charge of pharmaceuticals and food

January 9, 2009: Wholesalers dynamics:

Fri, 9 Jan 2009 10:43:09 +0900

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

January 6, 2009: Daiichi-Sankyo KK announced a non-cash valuation loss

Tue, 6 Jan 2009 18:19:23 +0900

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

January 5, 2009: JKS News: In 2009 the Japanese pharmaceutical industries

Mon, 5 Jan 2009 19:49:59 +0900

unscathed by the global financial crisis reorienting toward BRIC (Brazil, Russia, India and China) countries and other emerging markets

December 31, 2008: The Prasugel co-developers Eli Lilly KK and Daiichi-Sankyo KK announced

Wed, 31 Dec 2008 18:48:28 +0900

that critical FDA meeting regarding US approval is scheduled for February 3rd, 2009

December 17, 2008: M&A News: Mid-tier generics Daiso Chemical KK, acquires

Wed, 17 Dec 2008 17:48:09 +0900

bulk manufacturer Sanyo Fine KK to expand into pharmaceutical intermediates space

December 16, 2008: Ministry of Education, Culture, Sports, Science and Technology (MEXT) survey

Tue, 16 Dec 2008 09:43:55 +0900

found asthma in 2.7% of kindergarten pupils

December 12, 2008: Pirespa (Pirfenidone) obtained reimbursement price

Fri, 12 Dec 2008 10:43:15 +0900

for National Drug Tariff List; Shionogi Seiyaku KK started the market launch

December 10, 2008: Healthcare-oriented Social Democratic Party (SDP)

Wed, 10 Dec 2008 11:03:26 +0900

opposed sale of OTC products over Internet

December 5, 2008: The Japan Generic Pharmaceutical Manufacturers Association (JGPMA)

Fri, 5 Dec 2008 18:23:35 +0900

1)announced that the sales of generics for member companies for FY 2007 increased only with a single digit (5.6%)

December 4, 2008: Fukuoka-based Kurume University Hospital

Thu, 4 Dec 2008 10:43:15 +0900

to pioneer in 2009 the first in Japan center for non-reimbursable autologous cancer vaccination

December 3, 2008: MHLW survey found measles vaccination

Wed, 3 Dec 2008 12:18:51 +0900

rate still low at 50%

December 2, 2008: PMDA announced:

Tue, 2 Dec 2008 16:42:58 +0900

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

December 1, 2008: Medical device maker Mani KK selected as recipient of the annual Porter Prize 2008

Mon, 1 Dec 2008 17:52:08 +0900

bestowed in Japan for excellence in management practice, innovation and profitability

November 28, 2008: The First Subcommittee of Drugs of PAFSC, MHLW recommended for approval novel treatment

Fri, 28 Nov 2008 17:19:21 +0900

for age-related macular degeneration syndrome; positively review newest orphan drug designations

November 27, 2008: The Second Subcommittee of Drugs of PAFSC, MHLW

Thu, 27 Nov 2008 11:02:03 +0900

recommended for approval anti-HIV, anti-CML drugs, other products

November 26, 2008: The Non-prescription Subcommittee of PAFSC, MHLW

Wed, 26 Nov 2008 17:22:33 +0900

recommended for OTC switch two product for treatment of vaginal candidiases

November 25, 2008: Eli Lilly KK reported the outcome of 2008 family survey:

Tue, 25 Nov 2008 10:22:33 +0900

70% of women unsatisfied with ED awareness of their partners

November 21, 2008: Mid-tier generics manufacturer Nippon Chemical Research KK (JCR Pharmaceuticals)

Sun, 23 Nov 2008 11:02:03 +0900

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

November 20, 2008: MHLW personnel on a high security alert

Thu, 20 Nov 2008 11:10:09 +0900

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:

Wed, 19 Nov 2008 16:17:18 +0900

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.

November 18, 2008: Ms. Seiko Noda the State Minister

Tue, 18 Nov 2008 18:23:10 +0900

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"

November 17, 2008: JKS News: MHLW granted orphan status

Mon, 17 Nov 2008 19:24:59 +0900

of an anti-myelodysplastic syndrome product (ODD No. 217)

November 12, 2008: Mid-size generics maker Aska Seiyaku KK and Iceland-based Actavis Group PTC ehf

Wed, 12 Nov 2008 11:55:13 +0900

to established 55:45 shared Aska Actavis Seiyaku KK in Tokyo in 2009 for manufacturing and sales of generics from 2010

November 11, 2008: PMDA announced the creation of the "International Business Promotion Strategic Head Department"

Tue, 11 Nov 2008 14:25:36 +0900

led by Dr. Satoshi Toyoshima , PMDA Executive Director and Director of the Center for Product Evaluation to improve the international collaboration

November 10, 2008: M&A research provider Recof KK survey:

Mon, 10 Nov 2008 17:23:23 +0900

the value of Japanese M&A during Jan-Oct period increased 3.7 times compared to 2007

November 9, 2008: World Health Organization (WHO) Congress on Traditional Medicine

Mon, 10 Nov 2008 17:14:15 +0900

held in Beijing recognized the importance and therapeutic value of folk remedies used in Japan
WHO Statement

The year 2008 will be significant for WHO as it will be the 60th anniversary of WHO and the 30th anniversary of the Alma-Ata Declaration. The goal of the Alma-Ata Declaration was health for all by the year 2000 through promotion and strengthening of systems based on primary health care. The Alma-Ata Declaration is especially significant for traditional medicine (TM). Although TM has been used for thousands of years and the associated practitioners have made great contribution to human health, it was not until the Alma-Ata Declaration that countries and governments were called upon to include TM in their primary health systems for the first time, and to recognize the associated practitioners of TM as a part of the health care team, particularly for primary health care at the community level. It was at this time that the WHO Traditional Medicine Programme was established.

The use of TM has changed dramatically over the past thirty years. Due to the affordability, availability, and accessibility of traditional medicine it has played an important role in meeting the demands of primary health care in many developing countries, particularly in African and Asian countries, in the 1970's. Since the 1990s, use of TM has surged. It not only maintains its function in primary health care in developing countries (70 to 80% of the population in India and Ethiopia still depend on TM and practitioners for primary health care), use has been expanded widely in many developed countries where it functions under the title of complementary and alternative medicine (CAM). For instance, 70% of the population in Canada and 80% in Germany have used traditional medicine as complementary and alternative medical treatment.

In order to further review countries' progress and to facilitate Member States integrating TM/CAM into national health systems by sharing countries' experience and information related to national policy, regulation, research, education and practice, WHO will organize a WHO Summit Congress on Traditional Medicine on 7-9 November 2008, Beijing, China 2008 in co-sponsorship with the Ministry of Health and the State Administration of Traditional Medicine of China.

November 7, 2008: Daiichi-Sankyo KK finalized the acquisition of Ranbaxy Laboratories Ltd (RLL)

Fri, 7 Nov 2008 19:18:17 +0900

thus becoming the world 15th largest pharma company

November 6, 2008: Mr. Isao Teshirogi, President of Shionogi Seiyaku KK quoted as predicting size reduction of US pharma

Thu, 6 Nov 2008 20:21:22 +0900

of as much as 25-30 billions US$, in a consequence of election results

October 31, 2008: 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

Fri, 31 Oct 2008 12:25:36 +0900

starting with Laboratoires Daiichi Sanofi-aventis and Sanofi-aventis Daiichi Seiyaku KK, established in 1989 for anti-thrombotic treatment; other JV may follow

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

Thu, 30 Oct 2008 18:38:22 +0900

to bypass the ban on mixed insurance payment for high-expense treatment; the case likely to result in review of the regulations

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

Tue, 28 Oct 2008 16:55:38 +0900

in Tokyo that the company has enough "innovation and brainpower" for robust drug development

October 23, 2008: Dainippon Sumitomo Seiyaku KK ranked 7th among listed Japanese companies in term of R&D spending

Thu, 23 Oct 2008 12:33:41 +0900

announced the establishment of Neuropsychiatry Drug Discovery Consortium (NDDC) with Osaka University.
Notice of establishment of Drug Discovery Consortium in neuropsychiatric area.
Dainippon Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) has announced a plan to establish “Neuropsychiatry Drug Discovery Consortium; NDDC” this November jointly with five departments of Graduate School of Medicine and Graduate School of Pharmaceutical Sciences of Osaka University, a national university of Japan, (Headquarters: Suita City, Osaka; President: Kiyokazu Washida).

Today there are good many patients with symptoms of neuropsychiatric disorder represented by schizophrenia or depression, and, given their considerable influence over quality of life, more effective therapeutic modalities are badly needed to cure such diseases. For psychiatric medication, drugs originated from discoveries by “serendipity” (which means scientific discoveries by lucky chance) have traditionally been major remedies over the past nearly five decades. However, as a result of rapid progress of recent basic studies on mental diseases, circumstances are now being built up where new drugs could be discovered based on genetic level or molecular level studies of pathogenic mechanism, and it is hoped that revolutionary therapeutic medicines with unique features that conventional medicines do not have will be discovered.

Dainippon Sumitomo Pharma places importance on central nervous system (CNS) area as one of the priority research areas, and among antipsychotic agents, the company markets such proprietary products as LULLANR and LONASENR, and, in addition, is developing a lurasidone (generic name) globally. In October this year, the company set up “Funded Department of Molecular Neuropsychiatry (Dainippon Sumitomo Pharma)” at Graduate School of Medicine of Osaka University for the purpose of contributing to translation of basic research results to clinical practices in the field of psychiatric diseases.

At Osaka University, genetic risk studies on psychiatric illness are underway jointly by Graduate School of Medicine and Graduate School of Pharmaceutical Sciences. In parallel with such genetic level studies, those of cellular and whole organism levels are also conducted under the comprehensive research programs.
D
ainippon Sumitomo Pharma has extensive R&D experiences in the field of CNS, while Graduate School of Medicine and Graduate School of Pharmaceutical Sciences of Osaka University have a grand track record in their integrated researches on pathogenic mechanism of psychiatric disorder. These industry and academia jointly form “Neuropsychiatry Drug Discover Consortium”, under which various collaborative studies will be implemented with the hope of greatly contributing to development of science and technology in medical care as well as accelerating translation of basic researches to clinical practices in the field of psychiatric diseases. Future participation from other academic groups in this Consortium is under consideration.

October 21, 2008: The Office of Pharmaceutical Industry Research (OPIR)

Tue, 21 Oct 2008 15:28:23 +0900

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", found the average examination period to shorten to 20 months

October 20, 2008: Daiichi-Sankyo KK announced the acquisition

Mon, 20 Oct 2008 11:25:46 +0900

of 52.5% of the stock and transformation of Ranbaxy Laboratories Ltd (RLL) into subsidiary

October 16, 2008: The orphan drug Pirespa (Pirfenidone) developed by Intermune

Thu, 16 Oct 2008 15:15:33 +0900

(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)

October 16, 2008: The Minister of MHLW approved 33 new products and formulations,

Thu, 16 Oct 2008 14:56:33 +0900

including orphan drugs

October 16, 2008: Progenics Pharmaceuticals, Inc. licensed-out to Ono Seiyaku KK

Thu, 16 Oct 2008 12:46:33 +0900

development rights in Japan for methylnaltrexone bromide (MNTX) for the treatment of opioid-induced constipation

October 15, 2008: Bayer AG decided to delist from the foreign section of the Tokyo Stock Exchange (TSE)

Mon, 13 Oct 2008 11:11:11 +0900

Bayer to delist from the Tokyo Stock Exchange

Leverkusen, October 15, 2008 - On October 14, 2008 the Board of Management of Bayer AG decided to apply to delist the company from the Tokyo Stock Exchange, Inc. (TSE). Bayer'ss CFO Klaus Kün explained that the decision was due to the low turnover of Bayer stock on the TSE, which made the listing unnecessary. "Thanks to globalization, today's investors are no longer dependent on shares being traded on several continents. Instead, they generally prefer the stock exchanges with the highest trading volume in the shares" explained Kün. Bayer stock has been listed on the Japanese market since 1988.

October 13, 2008: Following financial downturn on the Tokyo Stock Exchange (TSE) the market capitalization of Eisai KK

Mon, 13 Oct 2008 11:11:11 +0900

felt below 1 trillion Yen threshold

October 11, 2008: The MHLW 2007 survey on corporation penetration of mental health measures:

Sat, 11 Oct 2008 12:16:23 +0900

only 33% (10% up) of poled firms have any policies at place

October 10, 2008: The two largest members of the Federation of Japan Pharmaceutical Wholesalers Associations (JPWA)

Fri, 10 Oct 2008 20:06:53 +0900

- Mediceo Paltac Holdings KK and Alfresa Holdings KK to merge into 4 trillion Yen pharma wholesales market leader

October 8, 2008: Mr. Takashi Shoda, the President of Daiichi-Sankyo KK warned about possible valuation loss

Wed, 8 Oct 2008 16:02:55 +0900

due to sharp decrease of acquired Ranbaxy Laboratories Ltd (RLL) stock price

October 7, 2008: The newest pharma company Kyowa Hakko Kirin KK inaugurated with focus on "bio"

Tue, 7 Oct 2008 10:48:33 +0900

October 3, 2008: The Pharmaceutical Affairs Committee of the PAFSC, MHLW recommended for pending approval thalidomide

Fri, 3 Oct 2008 19:15:12 +0900

for multiple sclerosis, other ten prescription and one OTC new products

October 1, 2008: The newest pharma company Kyowa Hakko Kirin KK inaugurated with focus on "bio"

Wed, 1 Oct 2008 18:18:18 +0900

October 1, 2008: Breast Cancer Awareness Campaign months starts

Wed, 1 Oct 2008 18:18:18 +0900

Tokyo Tower and and other contemporary landmarks illuminated in pink

October 1, 2008: The Economic Affairs Division, Health Policy Bureau, MHLW set up "Generic Drugs Use Promotion Office",

Wed, 1 Oct 2008 18:18:08 +0900

the ex-PMDA Mr. A. Shibukawa appointed as Head

September 30, 2008: The Japan Public Health Center-based Prospective Study Group, National Cancer Center

Tue, 30 Sep 2008 12:12:16 +0900

found in 80,000 subjects cohort study published in "American Journal of Epidemiology" that increased total daily physical activity is beneficial in cancer prevention.

ORIGINAL CONTRIBUTIONS

Daily Total Physical Activity Level and Total Cancer Risk in Men and Women: Results from a Large-scale Population-based Cohort Study in Japan

Manami Inoue¹, Seiichiro Yamamoto², Norie Kurahashi¹, Motoki Iwasaki¹, Shizuka Sasazuki¹, Shoichiro Tsugane¹ and for the Japan Public Health Center-based Prospective Study Group

¹ Epidemiology and Prevention Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan
² Cancer Information Services and Surveillance Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan

The impact of total physical activity level on cancer risk hasnot been fully clarified, particularly in non-Western, relativelylean populations. The authors prospectively examined the associationbetween daily total physical activity (using a metabolic equivalents/dayscore) and subsequent cancer risk in the Japan Public HealthCenter-based Prospective Study. A total of 79,771 general-populationJapanese men and women aged 45-74 years who respondedto a questionnaire in 1995-1999 were followed for totalcancer incidence (4,334 cases) through 2004. Compared with subjectsin the lowest quartile, increased daily physical activity wasassociated with a significantly decreased risk of cancer inboth sexes. In men, hazard ratios for the second, third, andhighest quartiles were 1.00 (95% confidence interval (CI): 0.90,1.11), 0.96 (95% CI: 0.86, 1.07), and 0.87 (95% CI: 0.78, 0.96),respectively (p for trend = 0.005); in women, hazard ratioswere 0.93 (95% CI: 0.82, 1.05), 0.84 (95% CI: 0.73, 0.96), and0.84 (95% CI: 0.73, 0.97), respectively (p for trend = 0.007).The decreased risk was more clearly observed in women than inmen, especially among the elderly and those who regularly engagedin leisure-time sports or physical exercise. By site, decreasedrisks were observed for cancers of the colon, liver, and pancreasin men and for cancer of the stomach in women. Increased dailyphysical activity may be beneficial in preventing cancer ina relatively lean population.

cohort studies; exercise; Japan; neoplasms; physical fitness

Abbreviations: CI, confidence interval; MET(s), metabolic equivalent(s)

September 29, 2008: Kitasato University and Harvard School of Public Health

Mon, 29 Sep 2008 11:15:15 +0900

jointly organized their 8th Symposium on "Advanced and Global Drug Development Techniques: Learning from Experience and New Challenges for the Future"

September 29, 2008: Two group companies of Mitsubishi Chemical Holdings KK - Tanabe-Mitsubishi Seiyaku KK and Benesis KK

Mon, 29 Sep 2008 11:11:11 +0900

settled the long-standing tainted blood products lawsuit, TM President Natsuki Hayama sealed the compensation agreement, apologized to the sufferers. On September 19, 2008, Tanabe-Mitsubishi Seiyaku KK published the following press release: "The Basic Agreement to Be Concluded with the National Plaintiffs Group on the HCV Class Action" Mitsubishi Tanabe Pharma Corporation ("the Company") announced that its Board of Directors resolved that the Basic Agreement is to be concluded with the national plaintiffs group and its lawyers in order to solve the cases, as the Company and its subsidiary Benesis Corporation ("Benesis") were sued for compensatory damages by those who claimed to have been infected with HCV (hepatitis C virus) via administration of the fibrinogen preparation and the blood coagulation factor IX preparation Christmassin made and sold by one of its predecessor companies Green Cross Corporation. The Basic Agreement is scheduled to be concluded on September 28. These cases currently examined in the regional and higher courts will be terminated after conclusion of the Basic Agreement, as the plaintiffs groups will sequentially disclaim compensation from Benesis and the Company. While the government proclaimed and enforced "the Special Relief Law Concerning the Payment of Benefits to Relieve the Patients of Hepatitis C Infected through Specified Fibrinogen Preparations and Specified Blood-Coagulation Factor IX Preparations Contaminated by Hepatitis C Virus" on January 16, 2008, we will discuss and determine the measures and ratios of benefit payments with the Minister of Health, Labour and Welfare, according to the terms of the Article 16 in this special measures law (discussion between the Minister of Health, Labour and Welfare and manufacturers, etc). As announced on May 7, 2008, the Company posted for future loss for these cases by budgeting. 11.2 billion yen as "reserve for HCV litigations" in the business year ended in March 2008. However, the amount of our payment may change depending on future discussions and increase/decrease in number of those who should receive the benefits."

September 25, 2008: Pharmaceuticals and Medical Devices Safety Information Bulletin No. 250 released,

Thu, 25 Sep 2008 18:15:10 +0900

package inserts of 22 interferon products found to case fatal interstitial pneumonia in Hepatitis C patients revised

September 24, 2008: The new Japanese Prime Minister lines up new Cabinet,

Thu, 25 Sep 2008 18:12:10 +0900

Health, Labor and Welfare Minister Yoichi Masuzoe re-appointed, leadership of Pharmaceutical Affairs and Food Safety Bureau (PAFSB) and PMDA unchanged

September 23, 2008: Teva Pharmaceuticals KK - a subsidiary of Teva Pharmaceutical Industries Ltd. and the unlisted Kowa KK

Tue, 23 Sep 2008 12:25:16 +0900

- a diversified business group, active in both R&D and OTC pharmaceuticals, to form a joint venture company - tentatively named Teva-Kowa Pharma KK for a full scale sale of generics from 2010

September 18, 2008: Mid-sized OTC and generics maker Mikasa Seiyaku KK to be de-listed

Thu, 18 Sep 2008 16:28:05 +0900

from Jasdag Stock Exchange after MBO

September 18, 2008: Movements on Medical Representative (MR) scene:

Thu, 18 Sep 2008 16:18:05 +0900

Banyu Seiyaku KK to scale down by 70% its sales locations; Mylan KK to increase the sales force to 300 MRs; the Japan Pharmaceutical Industry Legal Affairs Association (Ihouken) proposed a revision of the working contracts for MR for improving relations with project managers

September 16, 2008: The Center for Drug Evaluation and Research, FDA issues 2 Warning Letters to Ranbaxy Laboratories

Wed, 17 Sep 2008 10:28:25 +0900

and an Import Alert for drugs from two Ranbaxy plants in India: the actions affect over 30 different generic drugs, cites serious manufacturing deficiencies; shares of Daiichi-Sankyo KK unchanged in Tokyo

September 15, 2008: On the occasion of "Respect for the Aged Day"

Tue, 16 Sep 2008 19:25:25 +0900

the MHLW announced that the number of centenaries exceeds 36,000 and it is expected to reach 1 million in foreseeable future

September 12, 2008: The Committee of Drugs of PAFSC, MHLW approved the orphan drug designation

Mon, 15 Sep 2008 19:08:28 +0900

for Sodium phenylbutyrate of Ucyclyd Pharma (Medicis Corp.) and for GlaxoSmithKline Japan KK pre-pandemic anti-H5N1 vaccine (GSK1557484A)

September 12, 2008: Two food companies with pharma operations - Meiji Seika Kaisha KK and Meiji Nyugyu KK to merge

Mon, 15 Sep 2008 19:08:28 +0900

under Meiji Holding, existing Solvay Meiji Yakuhin KK and Hepatitis B vaccine production to be preserved, new focus on healthy food

September 12, 2008: Pharmaceutical Affairs and Food Safety Bureau (PAFSB) updated the list of approved FOSHU

Fri, 12 Sep 2008 16:05:18 +0900

(food for specified health uses) products - now reaching 1,032

September 11, 2008: Fuji Keizai KK 2008 Economic Survey:

Thu, 11 Sep 2008 13:02:15 +0900

with introduction in 2008 of the mandatory insurance check-up the market for metabolic syndrome increased by 18.7% and already reached 1.6 trillion Yen

September 10, 2008: National Institute of Infectious Diseases (NIID) unveiled that national measles vaccination level of pubescent population remains under 40%

Wed, 10 Sep 2008 14:22:18 +0900

of pubescent population remains under 40%

September 8, 2008: Team led by Dr. I. Tsuji from the Division of Epidemiology, Department of Public Health & Forensic Medicine,

Mon, 8 Sep 2008 09:28:31 +0900

Tohoku University Graduate School of Medicine, found in the Ohsaki Cohort Study published in "Psychosomatic Medicine" journal August 2008 issue that lack of "something to live for" (ikigai in Japanese) shortens life expectation. Ohsaki National Health Insurance Cohort Study: "From September to December 1994, all National Health Insurance beneficiaries, aged from 40 to 79 years, who live in 1 city and 13 towns in the catchment area of Ohsaki Public Health Center, Miyagi Prefecture were subjects of a questionnaire survey regarding health-related lifestyle. We received effective responses from 52,029 individuals (94.6%). After that, we traced medical care utilization and its costs in addition to death and cancer incidence. By this, in addition to conventional epidemiological research aimed at identification of risk factors, we investigate the impact of lifestyle upon medical costs. The two studies above, if combined, become a cohort study on a 100,000 person scale investigating the relation between health-related lifestyles and cancer incidence. No other single institute or university department in Japan maintains such a large-scale cohort study".

September 5, 2008: A MHLW Study Group on Safety Issues proposed an enhanced management safety system

Sun, 7 Sep 2008 17:36:45 +0900

in adverse events monitoring for the recommended for approval by the First Subcommittee of Drugs Thalidomide submitted by Fujimoto Seiyaku KK for treatment of multiple myeloma

September 1, 2008: Shionogi Seiyaku KK acquires 900-employee specialty drugs Sciele Pharma Inc.

Mon, 1 Sep 2008 12:56:45 +0900

to expand the sales network in North American market

August 29, 2008: The First Subcommittee of Drugs of PAFSC, MHLW recommended for approval Pirfenidone

Fri, 29 Aug 2008 20:28:45 +0900

developed by Intermune and submitted by Shionogi Seiyaku KK as the first treatment for idiopathic pulmonary fibrosis

August 28, 2008: The Second Subcommittee of Drugs of PAFSC, MHLW pre-approved orphan drug designation

Thu, 28 Aug 2008 13:29:45 +0900

for GlaxoSmithKline Japan KK pre-pandemic anti-H5N1 vaccine (GSK1557484A), domestic Phase II trial scheduled ... Orphan and GSK products in JAD Databases

August 25, 2008: PMDA released the updated Japan Drug Master Files listing of over 2,200 entries

Mon, 25 Aug 2008 11:29:45 +0900

... more details in JAD Databases

August 22, 2008: IHI Plant Engineering KK reported a purchase of 2% stock of UMN Pharma KK

Fri, 22 Aug 2008 18:27:45 +0900

(Unmet Medical Needs Pharma) developing anti-H5N1 recombinant influenza vaccine. The same day, UMN Pharma KK announced that it has reached a construction agreement with IHI Plant Engineering KK for the construction of manufacturing facility for UMN-0501, a pandemic influenza vaccine manufactured using a novel cell culture technique. The facility will be located in the Akita Prefecture and it is expected to be functional in 2010 with projected annual capacity of 10 millions doses.

August 20, 2008: Yakult Honsha KK acquired from USA-based Celsion Corp. development rights in Japan for ThermoDox,

Wed, 20 Aug 2008 11:22:45 +0900

a liposome-encapsulated doxorubicin

August 19, 2008: Nihon Keizai Shimbun ranks Dainippon Sumitomo Seiyaku KK

Tue, 19 Aug 2008 11:02:45 +0900

as the 7th among listed Japanese companies in term of capital spending and highest for pharma stock

August 18, 2008: Singapore Prime Minister Lee Hsien Loong declared that "Luring foreign talent gives Singapore edge over Japan",

Mon, 18 Aug 2008 11:02:45 +0900

by implication in pharma and healthcare as well

August 13, 2008: The Japan Productivity Center for Socio-Economic Development (JPC-SED)

Wed, 13 Aug 2008 16:02:45 +0900

published results from 4th "Approach to Mental Health" corporate survey: 56.1% of responders admit an increase of mental disorders among employees

August 12, 2008: The Federation of Japan Pharmaceutical Wholesalers Associations (JPWA) announced the results for FY 2007

Tue, 12 Aug 2008 15:02:45 +0900

with 0.2% decrease of gross profit and no change in operating profit

August 11, 2008: Daiichi-Sankyo KK launches open offer to the public shareholders of Ranbaxy Laboratories Ltd (RLL)

in effort to gain at least 50.1% of the stock

August 8, 2008: Pharmaceutical Affairs and Food Safety Bureau (PAFSB) revised counter indications for Interferon products (Pegasus)

in treatment of HBV and HCV infections; added safety precautions for antihypertensive drugs

August 7, 2008: Pharmaceutical Affairs and Food Sanitation Council discloses embarrassing error in the completed safety survey,

the Tamiflu saga to be continued

August 6, 2008: MHLW started to inoculate selected medical practitioners as first step against pandemic outbreak of new influenza strains

as first step against pandemic outbreak of new influenza strains

August 5, 2008: The 64th Japanese regulatory authorities' periodic information meeting

"The 18th ICH Immediate Briefings" held in Tokyo

August 4, 2008: The unlisted Kowa KK - a diversified business group, active in both R&D and OTC pharmaceuticals, acquires US-based specialty drugs ProEthic Pharmaceuticals Inc.,

to support the North America launch of Livalo (pitavastatin), plans to rename the company to Kowa Pharmaceuticals America Inc. on September 1, 2008

August 4, 2008: MHLW's designates 2 new orphan products

(ODD No. 213 and ODD No. 214)

August 3, 2008: PM Fukuda reshuffles the Cabinet, appoints the MP and ex-Environment Minister Dr. Ichiro Kamoshita

- a physician, as Senior Vice-Minister of MHLW to carry the healthcare reforms

August 1, 2008: MHLW held hearing on 2007 "New Pharmaceutical Industry Vision and Action Plan for its Achievement",

priority given to vaccine development, EFPIA, PhRMA voiced opinions

July 31, 2008: Chugai Seiyaku KK reports half-year earnings,

sales of Tamiflu dropped by 93%

July 30, 2008: Financially-indebted but ambitious Osaka Prefectural Government to create Japan's largest biotechnology hub

based on Saito Life Science Park, Osaka University Faculty of Medicine and historic downtown Doshomachi pharma companies HQ area

July 29, 2008: While Cultural Affairs Agency found "stress" to be most recognizable (98.5%) foreign word in Japan

indiscriminate knife attacks by undiagnosed and untreated psychotic persons become a weekly occurrence

July 28, 2008: Embattled Tanabe-Mitsubishi Seiyaku KK recovered from tainted blood products Hepatitis C disaster

to expand in 2008 to the 4th largest share (4.9%) of prescription drugs sales in Japan, displacing both Pfizer and Chugai

July 25, 2008: Mr. Y. Hasegawa - the Vice-Chairman of Keizai Doyukai (Japan Association of Corporate Executives) and President of Takeda Yakuhin

introduces the JACE vision for "Creating a New Style of Japanese Management" and postulates that the unique Takeda's management style and corporate culture is the only barrier against foreign acquirers

July 24, 2008: MHLW made public the 2008 draft version of "Medical Devices Industry Vision"

mapping plans for the next 5 years, now soliciting public opinions

July 23, 2008: Otsuka Holding Group, a diversified 100-member conglomerate to acquire all Itoham Life Science KK properties

including American Peptide Co. to expand its ingredients and API capacities

July 22, 2008: MHLW announces coming release of "Five Peace-of-Mind Plans"

for overhaul of social security system, possibly ministry's administrative restructuring

July 21, 2008: Momenta Pharmaceuticals successfully submitted in US the first generic version of Copaxone (Glatiramer acetate)

an yet unapproved in Japan product indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS)

July 18, 2008: MHLW released for qualified public comments the Step 2 draft

of ICH Harmonised Tripartite Guideline "Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals"

July 17, 2008: Kinetic Concepts Inc. announced that by end of June has completed in Japan the Phase II trial

required for approval of its negative pressure wound therapy (NPWT) technique

July 16, 2008: The Japan Medical Association published a full-page petition

in national newspapers soliciting Japanese citizens to protest 220 billion Yen health insurance cost-reduction plan of the Government

July 16, 2008: MHLW approved 23 new products

including anti-cancer drugs in summer round of approval

July 15, 2008: PMDA starts soliciting public comments in relation to the Pharmacopoeia Discussion Group (PDG)

international harmonization of the Japanese Pharmacopoeia XV

July 14, 2008: Researcher at the Molecular Therapy, Advanced Clinical Research Center,

Institute of Medical Science, University of Tokyo admits falsifying IRB approval, retracts the published in May 2008 in Ferrata Storti Foundation medical journal Haematologica article (http://www.haematologica.org/cgi/content/full/93/7/1103); all photographs of the disgraced Arinobu Tojo removed from the web sites of University of Tokyo MHLW to revise the clinical research and tissue handling guidelines

July 12, 2008: MHLW announced positively concluded 1-year 10,000 person Tamiflu safety survey

final decision on use restriction coming next

July 11, 2008: The 63rd Japanese regulatory authorities' periodic information meeting

"Drugs and Medical Devices Production Monitoring - Emphasis on GMP, QSM, Counterfeiting and Narcotics" held in Tokyo

July 11, 2008: MHLW appoints Mr. Yasuyuki Takai

(former Head of the Public Affairs Office to the Cabinet Secretariat) as new Director-General of PAFSB, promotes Mr. Kazuhiko Mori to Head of the Safety Division

July 10, 2008: Sekisui Medical KK, a subsidiary of Sekisui Chemical KK conglomerate acquires US-based XenoTech,

to expand capabilities for "evaluating drug candidates as substrates, inhibitors and inducers of Cytochrome P450 enzymes"

July 8, 2008: Regardless of sensational claims of Indian tabloids for Pfizer's counterbid

, Daiichi-Sankyo KK remains the only contender for Ranbaxy Laboratories Ltd (RLL) after expiration of the legal bid-logging period

July 7, 2008: MHLW released survey results

for dementia and juvenile dementia prevalence

July 4, 2008: After spinning-off its Aichi Central Research Laboratories and world-auctioning its equipment

Pfizer KK became 3rd largest stockholder in RaQualia Souyaku KK

July 3, 2008: Kyoto University established iPS Academia Japan KK

to "prevent some groups or companies from monopolizing the iPS technology", the lead researcher says meaningful therapeutics 30 years away

July 2, 2008: BioForum/BioExpo, Interphex Japan 2008 opened in Tokyo, most of the key domestic and foreign pharmaceutical companies conspicuously absent from 650 exhibitors

most of the key domestic and foreign pharmaceutical companies conspicuously absent from 650 exhibitors

July 2, 2008: Researchers at Duke University Medical Center published "MicroRNAs expressed by herpes simplex

virus 1 during latent infection regulate viral mRNAs" - with a potential new approach for treatment of herpetic infections

July 1, 2008: MHLW revamps the web site,

introduces new logo, content for mobile phone users

July 1, 2008: The introduction of age-verification TASPO card for vending machine cigarettes purchase

projected to increase the demand for OTC smoking-cessation aids

June 30, 2008: PMDA discloses salaries and bonuses

for executives and regular employees

June 26, 2008: Sanofi Pasteur SA inaugurates 20 types of vaccines manufacturing facility in France,

the CEO declares in WSJ interview plans to invest 4 billion Euro in 15 manufacturing sites around the world

June 26, 2008: The Federations of the Pharmaceutical Manufacturers' Associations of Japan (FPMAJ) projects in the next 10-20 years 5 trillion Yen decrease

of Japanese pharma market value due to wider use of generics to be offsetted by 3.3 trillion Yen increase due to improved drug evaluation thus resulting eventually in 1.7 trillion Yen overall market shrinkage

June 25, 2008: The NPO "Japan Committee Vaccines for the World's Children" (JCV)

launched an original recycled PET bottles plastic caps collection initiative to raise funds for vaccine donations to developing countries in Asia

June 24, 2008: The Minister of MHLW announced plans to increase to 10 billion Yen the spending for research on intractable diseases

(Amyotrophic Lateral Sclerosis, Parkinson, etc.) and to increase the number of targets from currently designated 123 conditions

June 20, 2008: Specific Disease Control Division of the Health Services Bureau, MHLW announced the "Seven-year Strategy for Hepatitis Research"

plan numerically targeting 70% recovery rate, much earlier diagnosis and increase of 5-year liver cancer survival rate from current 25% to 40%

June 20, 2008: PMDA invites qualified opinions

for the Second Supplement of the Japanese Pharmacopoeia XV Editions due in Spring 2009

June 17, 2008: The Pharmaceutical Affairs Committee of the PAFSC, MHLW

authorized immediate approval of anti-HIV Isentress (Raltegravir) submitted by Banyu Seiyaku, pre-approved other products

June 17, 2008: IMS Japan announced 5.5% increase of the Japanese pharma market size

with Blopres as leading product,a decrease in Japan of biologicals sales to 5% global share in FY2007

June 17, 2008: Abbott Japan expects anti rheumatoid arthritis Humira

to contribute in reaching 1 billion sales in two years

June 16, 2008: The Drug Price Study Group of The Federations of the Pharmaceutical Manufacturers' Associations of Japan (FPMAJ)

held a meeting to discuss pricing methods for new drugs, market share calculations, generics, effect of 2008 cut

June 11, 2008: Daiichi-Sankyo KK launches TOB to Ranbaxy Laboratories Ltd (RLL)

India's largest pharmaceutical company for 4.6 billion US$ to secure share in world generic market

June 10, 2008: Unmet Medical Needs Pharma KK (UMN Pharma) announced

that the in-licensed in 2006 from Protein Sciences Corp. FluBlok anti-H5N1 recombinant influenza vaccine is to enter in June 2008 Phase I trial in Japan

June 9, 2008: Self-proclaimed psychotic but undiagnosed homicidal knife-attacker of 17 in Tokyo

underscores again the scale of undetected mental disorders and lack of psychiatric vigilance

June 8, 2008: Otsuka Seiyaku Group, a diversified 80-member healthcare conglomerate

and the largest non-listed pharma company in Japan announced new corporate symbol and formation of holding organization

June 7, 2008: MHLW's designates 4 new orphan products (ODD No. 209-212)

declare the 2010 introduction of daylight saving time (summer time) unsuitable for Japanese population, forecasting serious damages of national health due to sleep disorders and 120 billion Yen of loses for drugs and medical fees

June 6, 2008: The Japanese Society of Sleep Research (JSSR) held a press conference,

declare the 2010 introduction of daylight saving time (summer time) unsuitable for Japan, forecasting serious damages of national health due to sleep disorders and 120 billion Yen of loses for drugs and medical fees

June 5, 2008: Hisao Endo, Chairman of Central Social Insurance Medical Council displeasured, perplexed

by the description of the MHLW Minister Yoichi Masuzoe of CSIMS practices as "opaque" at the meeting of "Vision for Relief and Desired Medical Care Security" Committee

June 4, 2008: Central Social Insurance Medical Council (CSIMC) held the 129th Meeting with agenda:

NHI reimbursement prices of 23 formulations of new products; application of DPC (Diagnosis Procedure Combination) to new, high-priced drugs; review of medical treatment fee 2008 revision results

June 4, 2008: The Clinical Data Interchange Standards Consortium (CDISC) Japan Interchange 2008

opened in Tokyo with two days training sessions and follow-up CDISC Japan Interchange 2008 Conference

June 3, 2008: Kissei Seiyaku KK announced that has granted the remaining world-wide rights on KGT group

of selective SGLT-2 inhibitors to GlaxoSmithKline Japan KK for development as anti-diabetic and anti-obesity therapeutics

June 2, 2008: PMDA's "Team Minus 6%" request all visitors to the agency to observe the CoolBiz

"no neckties, no jackets" summer style as a measure against global warming and for energy preservation

May 29, 2008: The Japan Pharmaceutical Manufacturers Association (JPMA) announced at media press conference

that for FY 2007, all of its listed member companies recoded increased sales, including from overseas, but expect 20% decline on pretax profit due to price drug cut

May 28, 2008: In spite of the "Anti-suicide Measures White Paper" policy adopted by the Government

the suicides in 2007 including caused by depression and mental disorders is projected to exceed 30,000 for 10th consecutive year

May 26, 2008: Second and First Subcommittee of Drugs of PAFSC, MHLW pre-approved new products,

including pediatric medications and orphan drugs

May 25, 2008: The Japan Business Federation (Nippon Keidanren) and also the Japan Chamber of Commerce and Industry (JCCI)

plan to ask the Government to stockpile anti-influenza vaccines for the entire population

May 23, 2008: Roche Pharmholding B.V. launched a tender offer for 59.9% stake in Chugai Seiyaku KK

increasing its majority holding, but Chugai Seiyaku will not be delisted from Tokyo Stock Exchange

May 23, 2008: Roche Pharmholding B.V. launched a tender offer for 59.9% stake in Chugai Seiyaku KK

increasing its majority holding, but Chugai Seiyaku will not be delisted from Tokyo Stock Exchange

May 22, 2008: Mr. Takashi Shoda, the Chairman of the Japan Pharmaceutical Manufacturers Association (and the President of Daiichi-Sankyo KK) pointed out at a press conference on May 22 that the share Japan occupies in the world drug market has been reduced by half compared with ten years ago, due to the Goverment initiatives to cut the drug prices.

Other issues of concerns are the clinical trials, approval examination, trials in Asian region and patent terms extension. The JPMA has set up a task force to work on a proposal for a new drug price system.

May 21, 2008: Daiichi-Sankyo KK acquires anti-cancer antibodies developer U3 Pharma

stock market reacts non-enthusiastically

May 21, 2008: The President of the cosmetics and pharma maker Shiseido confirmed the previously announced "Non-continuation of Plan for Countermeasures to Large-scale Acquisitions of Shiseido Co., Ltd. Shares (Takeover Defense Measures)",

thus becoming one of the first Japanese pharma companies to scrap completely its anti-takeover

May 20, 2008: MHLW released the "2008 White Paper on Aging Society"

- 10% of the population is now over 75 years old

May 20, 2008: Dr. Tadao Kakizoe, Honorary President of the Japan National Cancer Center and Chair of the MHLW's Council for Cancer Control published a policy paper "Pro-market Theory Hurts Health Care"

denouncing HMO and other for-profit initiatives as not applicable to Japan

May 16, 2008: IMD (International Institute for Management Development)

ranked Japan 22nd in "The World Competiveness Scoreboard 2008" among 55 economies

May 15, 2008: Brandes Investment Partners, L.P., a 7% stock holder reverted its April request to Ono Seiyaku KK

to pay dividends and expand share-buyback program

May 14, 2008: Yomiuri Shimbun survey: as 85% of municipalities offer free consultation

to 56 million eligible for the mandatory metabolic syndrome health check, the financial burden not relived by the central Government

May 13, 2008: MHLW's disclosed the proceedings of the 7th meeting of the Advisory Committee

responsible for creating 10-years "Vision for Relief and Desired Medical Care Security"

JKS News: Ruling LDP confirms the dedication to increase the use of generics:

Mr. Yuya Miwa, a senior lawmaker from the ruling Liberal Democratic Party (LDP)and former Chairman of the LDP's Executive Council and Minister of Health and Welfare, in the keynote presentation at the meeting of the Japan Pharmacies Associations (NPhA) announced that Government's aim for 30% generics by 2012 is achievable even without US-style compulsory prescription

Nihon Keizai Shimbun: 6 of the largest foreign corporate investors in Japan

demand 500 of listed firms to abolish takeover defenses, to reduce cross shareholding and to appoint 3 outside board members

JKS News: Takeda Yakuhin reports successful closing of the TOB for Millennium Pharmaceuticals

and over 50% drop in projected net profit for FY 2008

JKS News: Japan Patent Office to introduce 2-week ultra-fast patent review

procedure for critical invention in biotech, healthcare and other high technologies

MHLW ordered Fuso Seiyaku to recall 370,000 ampoules of Heparin-containing products

... details of Heparin-containing products approved in Japan are available in JAD Databases

Second Subcommittee of Drugs of PAFSC, MHLW pre-approved Isentress (Raltegravir) submitted by Banyu Seiyaku, other products

... details of products approved in Japan are available in JAD Databases

JKS News: Japan Drug Master Files updated as of March 30, 2008

... details of products approved in Japan are available in the JAD Databases

First Subcommittee of Drugs of PAFSC, MHLW pre-approved Macugen (Pegaptanib sodium), other products

... details of products approved in Japan are available in the JAD Databases

Mid-size pharma maker Aska Seiyaku first to take advantage of expired patent of Amlodipine besylate, releasing also 3 other generic drugs in FY 2008

... details of products approved in Japan are available in the JAD Databases

Fujifilm Holdings tender offer for 66% controlling stake in Toyama Kagaku KK completed successfully

Taisho Seiyaku KK remains as junior co-owner.

After acquiring Amgen KK in February, Takeda Yakuhin to buy-out all Abbott's shares in their overseas JV TAP Pharmaceuticals

plans to merge TAP with Takeda Pharmaceuticals North America Inc., to increase the sales staff to 4,300, and to move upward in global ranking from 17th to 14th position.

Sanofi-aventis KK plans to invest 1 billion Yen in enhancing production in Kawagoe manufacturing plant

and to dissolve all co-marketing agreements with domestic firms, including Daiichi Sankyo, Chugai Seiyaku, Fujisawa Sanofi-Aventis

Nichi-Iko Seiyaku KK to acquire Teikoku Medix KK

aiming to become the largest generics maker in Japan.

Pfizer KK auctions the former Japanese Central Research Laboratory equipment

as a part of restructuring its operations in Japan.