Regulation - Pharmaceutical, Asia-Pacific

Filter

Popular Filters

1 to 25 of 215 results

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

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

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

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

10-02-2014

Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

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

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

Japanese approval for Bayer’s riociguat for CTEPH

Japanese approval for Bayer’s riociguat for CTEPH

20-01-2014

German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat,…

AdempasAsia-PacificBayerPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

Astellas gains Japanese clearance for diabetes drug Suglat

Astellas gains Japanese clearance for diabetes drug Suglat

20-01-2014

Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor…

Asia-PacificAstellas PharmaDiabetesipragliflozinKotobuki PharmaceuticalMerck & CoPharmaceuticalRegulationSuglat

Allergan closes $65 million deal with Medytox

Allergan closes $65 million deal with Medytox

09-01-2014

This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement…

AllerganAsia-PacificBotoxDermatologicalsLicensingMedytoxPharmaceuticalRegulationUKUSA

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

09-01-2014

Due to its large population and substantial unmet medical needs, India represents a market with strong…

Asia-PacificIndiaMarkets & MarketingPharmaceuticalPricingRegulation

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

08-01-2014

Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a Marketing Authorization Application to…

Asia-PacificCardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulation

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

US global share of biomedical research spending declines, as Asia gains

02-01-2014

The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

Ono Pharma files for approval of nivolumab for melanoma in Japan

30-12-2013

Japanese drugmaker Ono Pharmaceutical has filed an application to obtain a manufacturing and marketing…

Asia-PacificBristol-Myers SquibbnivolumabOncologyOno PharmaceuticalPharmaceuticalRegulation

1 to 25 of 215 results

Company Spotlight

ImmunoGen

ImmunoGen

Back to top