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Bristol-Myers files for Japanese approval of first all-oral, interferon/ribavirin-free hep C treatment

Bristol-Myers files for Japanese approval of first all-oral, interferon/ribavirin-free hep C treatment

03-11-2013

US drug major Bristol-Myers Squibb has filed a New Drug Application with Japan’s Pharmaceutical and…

Anti-viralsAsia-PacificasunaprevirBristol-Myers SquibbdaclatasvirPharmaceuticalRegulation

Eisai seeks expanded Japanese indication for Aricept

Eisai seeks expanded Japanese indication for Aricept

01-11-2013

Japanese drug major Eisai says it has filed an application for its already marketed anti-Alzheimer's…

AriceptAsia-PacificEisaiNeurologicalPharmaceuticalRegulation

Wockhardt hit hard by MHRA’s withdrawal of certificate

Wockhardt hit hard by MHRA’s withdrawal of certificate

15-10-2013

Indian drugmaker Wockhardt has had its Good Manufacturing Practice certificate revoked by the UK’s…

Asia-PacificPharmaceuticalProductionRegulationWockhardt

Dramatic increase in use of generic drugs in Japan confirmed

Dramatic increase in use of generic drugs in Japan confirmed

15-10-2013

A subcommittee of Japan’s Central Social Insurance Medical Council looked at the effect of the April…

Asia-PacificGenericsMarkets & MarketingRegulation

Stem cell rules clear and adequate, says Philippines FDA

Stem cell rules clear and adequate, says Philippines FDA

14-10-2013

The Philippines Food and Drug Administration (PFDA) has said its guidelines governing stem cell therapy…

Asia-PacificBiotechnologyRegulation

EU and Japan improve information-sharing using EudraGMDP database

EU and Japan improve information-sharing using EudraGMDP database

08-10-2013

Information will be shared between Japan and the European Union about good practice compliance relating…

Asia-PacificEuropePharmaceuticalRegulation

Japanese lawmakers are stepping in to Diovan investigation

07-10-2013

Members of Japan’s Diet (Congressmen) have formed a bipartisan study group to examine Swiss drug major…

Asia-PacificCardio-vascularDiovanNovartisPharmaceuticalPoliticsRegulationResearch

Indian pharmaceutical market to reach $56 billion by 2020, says GlobalData

03-10-2013

Driven by the country’s growing economy and population income, the Indian pharmaceutical market will…

Asia-PacificMarkets & MarketingPatentsPharmaceuticalRegulation

Novartis under investigation for manipulating data in Japanese clinical trials

Novartis under investigation for manipulating data in Japanese clinical trials

27-09-2013

Swiss drug major Novartis has said it regrets the inconvenience caused by its investigator-initiated…

Asia-PacificCardio-vascularLegalNovartisPharmaceuticalRegulationvalsartan

CSL Behring’s Hizentra approved in Japan for PID and SID

CSL Behring’s Hizentra approved in Japan for PID and SID

27-09-2013

The Japanese Ministry of Health, Labor and Welfare has approved Hizentra for the treatment of primary…

Asia-PacificCSL BehringHizentraImmunologicalsPharmaceuticalRare diseasesRegulation

Australian generics group releases new edition of Code of Practice for public consultation

Australian generics group releases new edition of Code of Practice for public consultation

26-09-2013

Australia’s Generic Medicines Industry Association this morning released the draft third edition of…

Asia-PacificGenericsMarkets & MarketingRegulation

Rising focus on R&D in India whose pharma exports have reached $14.5 billion

Rising focus on R&D in India whose pharma exports have reached $14.5 billion

24-09-2013

The domestic pharmaceutical industry in India has been growing at a CAGR of over 14.5% for the past four…

Asia-PacificGenericsMarkets & MarketingRegulation

CHMP positive decision for Kadcyla, and approval in Japan

20-09-2013

The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European…

Asia-PacificEuropeImmunoGenKadcylaOncologyPharmaceuticalRegulationRoche

Otsuka's Samsca gains additional indication in Japan

17-09-2013

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan)…

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

17-09-2013

There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

Generics market in Southeast Asia set for growth

15-09-2013

With its fast-growing, young population and uninsured majority in Southeast Asia, countries in the region…

Asia-PacificGenericsMarkets & MarketingPricingRegulation

Alexion's Soliris gets approval in Japan for rare disorder

13-09-2013

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Soliris (eculizumab) from US drugmaker…

Alexion PharmaceuticalsAsia-PacificPharmaceuticalRare diseasesRegulationSoliris

Indication changes for Glufast approved in Japan

13-09-2013

Japanese drugmakers Kissei Pharmaceutical (TYO: 4547) and Takeda Pharmaceutical (TYO: 4502) have received…

Asia-PacificDiabetesGlufastKissei PharmaceuticalPharmaceuticalRegulationTakeda Pharmaceuticals

New Zealand reaches agreement with Sanofi to fund ALS drug

11-09-2013

New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of an agreement with…

Asia-PacificNeurologicalPharmaceuticalRare diseasesRegulationRilutekSanofi

In wake of bribery allegations, China pharma industry reforms urged

04-09-2013

Following the revelation of further details regarding alleged financial violations by UK pharma giant…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan

29-08-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

Eisai gains WHO prequalification for DEC; launches high-dose Aricept in Korea

27-08-2013

Japanese drug major Eisai (TYO: 4523) has received prequalification from the World Health Organization…

AriceptAsia-PacificdiethylcarbamazineEisaiMarkets & MarketingNeurologicalPharmaceuticalRegulationTropical diseases

Mylan's deal to acquire Strides Arcolab's unit looks set to proceed

22-08-2013

US generics and specialty drugmaker Mylan (NYSE: MYL) $1.6-billion foreign direct investment proposal…

Agila SpecialitesAsia-PacificGenericsMergers & AcquisitionsMylan LaboratoriesRegulationStrides Arcolab

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