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Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

14-11-2014

Ethical business practices promoted by industry representative Medicines Australia in Asia Pacific are…

Asia-PacificAustraliaMedicines AustraliaPharmaceuticalRegulation

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

13-08-2014

The inaugural Healthcare Meetings Forum Asia was over-subscribed on August 1 at Suntec Singapore, an…

Asia-PacificMarkets & MarketingPharmaceuticalRegulationSingapore

Vietnam’s pharma market set to expand at CAGR of 15% to 2020

Vietnam’s pharma market set to expand at CAGR of 15% to 2020

30-05-2014

The pharmaceutical market in Vietnam is set to increase in value by $5 billion over the next six years,…

Asia-PacificMarkets & MarketingPharmaceuticalRegulationVietnam

Indian regulator seeks to address the nation’s substandard drugs problem

Indian regulator seeks to address the nation’s substandard drugs problem

22-04-2014

In what is something of an indictment of India’s pharmaceutical industry, the Drug Controller General…

Asia-PacificIndiaPharmaceuticalProductionRegulation

First Asian approval for ophthalmic drug Jetrea, in Malaysia

18-04-2014

Belgian biotech firm ThromboGenics NV revealed today that Jetrea (ocriplasmin) has been approved in Malaysia…

AlconAsia-PacificBiotechnologyJetreaMalaysiaNovartisOphthalmicsRegulationThromboGenics

RAPS Taiwan Chapter becomes first in Asia

11-04-2014

The Regulatory Affairs Professionals Society (RAPS) has announced the establishment of a new chapter…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Astellas’ Xtandi cleared in Japan for prostate cancer treatment

24-03-2014

Japanese drug major Astellas Pharma has obtained the marketing approval in Japan of its oral androgen…

Asia-PacificAstellas PharmaJapanMedivationOncologyPharmaceuticalRegulationXtandi

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

Taiwan’s TaiGen Biotech receives domestic marketing approval for Taigexyn

13-03-2014

Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has…

Antibiotics and Infectious diseasesAsia-PacificBiotechnologyRegulationTaiGen BiotechTaigexyn

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan

09-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

Streamlined PBS pricing processes to improve access to medicines in Australia

Streamlined PBS pricing processes to improve access to medicines in Australia

07-03-2014

From April 1, the Australian government will implement a new streamlined process to reduce the time taken…

Asia-PacificAustraliaPharmaceuticalPricingRegulation

Novartis gets fourth indication, DME, for Lucentis in Japan

24-02-2014

Swiss drug major Novartis says it has received approval from Japanese regulatory bodies for a fourth…

Asia-PacificJapanLucentisNovartisOphthalmicsPharmaceuticalRegulation

Indian drugmakers readying for next “Patent cliff”

24-02-2014

The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest…

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

2014 to be transition year for Japan pharma

2014 to be transition year for Japan pharma

11-02-2014

2014 will be marked as a transition year for the Japanese Pharma industry – but the year is bound to…

Asia-PacificPharmaceuticalPricingRegulationResearch

Regulatory update on Indian clinical research approval timelines

04-02-2014

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry…

Asia-PacificIndiaPharmaceuticalRegulationResearch

Chinese health professionals' conduct to be regulated

29-01-2014

China's National Health and Family Planning Commission this week issued a draft regulation on health…

Asia-PacificChinaPharmaceuticalRegulation

India loses its attraction for pharma clinical trials, as domestic regulations tighten

India loses its attraction for pharma clinical trials, as domestic regulations tighten

27-01-2014

Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with…

Asia-PacificBioconIndiaPharmaceuticalPiramal HealthcareRegulationResearch

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

Norgine and Kissei’s Savene approved in Japan

21-01-2014

Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from…

Asia-PacificKissei PharmaceuticalNorgineOncologyPharmaceuticalRegulationSavene

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