Regulation - Asia-Pacific


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US and Indian biotech industry find common ground on key issues


The third annual BIO India conference kicked off yesterday in Mumbai with significant agreement among…

Asia-PacificBiotechnologyNorth AmericaPatentsRegulationResearch

India, WHO and PSM India to collaborate to curb spurious and sub-standard medicines


At an international workshop in New Delhi, it was announced that the Indian government, the World Health…

Asia-PacificGenericsMarkets & MarketingPharmaceuticalProductionRegulation

Australia leading world in medicines Code, claims trade group


Australia is a world leader in pharmaceutical industry conduct, and will continue to work towards further…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

Dainippon Sumitomo files for approval of Calsed in China


Japanese drug major Dainippon Sumitomo Pharma (TYO: 4506) has submitted an imported drug registration…

Asia-PacificCalsedDainippon Sumitomo PharmaOncologyPharmaceuticalRegulation

Eisai gets South Korean approval for breast cancer drug Halaven


The South Korean sales subsidiary of Japanese drug major Eisai (TYO: 4523) has received approval from…


Otsuka files Abilify, first antipsychotic for major depressive disorder in Japan


Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has filed an additional indication for Abilify (aripiprazole)…


Novo Nordisk insulin degludec passes first regulatory hurdle in Japan


Danish insulin giant Novo Nordisk (NOV: N) revealed on Friday that its ultra-long-acting insulin degludec…

Asia-PacificDegludecDiabetesNovo NordiskPharmaceuticalRegulation

Medicines Australia sets up new taskforce on transparency for payments to doctors


Medicines Australia has invited the Australian Medical Association, the Royal Australian College of Physicians,…

Asia-PacificFinancialMarkets & MarketingPharmaceuticalRegulationResearch

Shionogi partner Ildong gains South Korean approval for Pirespa


Japanese drug major Shionogi (TYO: 4507) says that its South Korean partner Ildong Pharma has received…

Asia-PacificIldong PharmaPharmaceuticalPirespapirfenidoneRegulationRespiratory and PulmonaryShionogi

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin


Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

EMA increases interaction with Japanese regulators


The European Medicines Agency has increased its level of interaction and cooperation with medicines regulatory…

Asia-PacificBiotechnologyEuropePharmaceuticalRare diseasesRegulation

Australia's health care regulations struggle to keep up with population aging


The growing elderly population and its associated disease burden add to the economic challenges faced…

Asia-PacificHealthcareMarkets & MarketingPharmaceuticalPricingRegulation

Australian pharma companies to disclose payments to doctors under new Code of Conduct


Australian pharma trade group Medicines Australia says that its new Code of Conduct will require member…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

New Zealand agrees to fund Iressa but amends Tarceva use


New Zealand's pharmaceutical management agency PHARMAC has approved the proposal to fund AstraZeneca's…


Russia urged to open up its pharmaceuticals market to Indian imports


Russia should open its booming $19 billion pharmaceuticals market and expedite the list of 500 drugs…

Asia-PacificEuropeGenericsMarkets & MarketingPoliticsRegulation

Teijin and Ipsen's Somatuline cleared in Japan


Japanese drugmaker Teijin Pharma (TYO: 3402) revealed last Friday that it has received manufacturing…

Asia-PacificIpsenPharmaceuticalRare diseasesRegulationSomatulineTeijin

Australia's Greens want end to Big Pharma inducements


Ahead of an announcement by pharma trade group Medicines Australia on a new Code of Conduct this week,…

Asia-PacificBiotechnologyMarkets & MarketingPharmaceuticalRegulation

Australian patients to benefit from new PBS listings; OTC reforms


The listing of 11 prescription medicines on the Australian Pharmaceutical Benefits Scheme (PBS) has been…


SkyePharma partner Kyorin completes Japanese Flutiform clinical program


UK drug delivery specialist SkyePharma (LSE: SKP) saw its shares leap nearly 11% to £76.50 last…

Asia-PacificFlutiformKyorin PharmaceuticalsPharmaceuticalRegulationResearchRespiratory and PulmonarySkyepharma

Australian medicines could lead the way for manufacturing in the "Asian century"


If supported by good public policy, medicines could play a significant role in ensuring Australia adapts…

Asia-PacificGenericsMarkets & MarketingPatentsRegulation

Osiris gets second approval for Prochymal, in New Zealand


USA-based Osiris Therapeutics (Nasdaq: OSIR) has received a second approval to market its first-in-class…

Asia-PacificBiotechnologyImmunologicalsOsiris TherapeuticsProchymalRegulation

Australia's PIC reports to Ministers on treatment and reimbursement of similar biologics


The Australian Pharmaceuticals Industry Council (PIC), with industry group members AusBiotech, Medicines…


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