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2014 to be transition year for Japan pharma

2014 to be transition year for Japan pharma


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


Regulatory update on Indian clinical research approval timelines


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


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

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


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

Asia-PacificBioconIndiaPharmaceuticalPiramal HealthcareRegulationResearch

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


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

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan


The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

Australia’s TGA streamlines adverse event reporting


Australia’s medicines regulator the Therapeutic Goods Administration (TGA) has introduced a streamlined…


Japanese lawmakers are stepping in to Diovan investigation


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


Indian pharma threatened by trend of shifting R&D operations overseas: survey


Red tape is putting India's multi-billion dollar worth pharmaceutical industry at risk, with most of…

Asia-PacificGenericsMarkets & MarketingPharmaceuticalRegulationResearch

Sinovac rockets on strong data for Enterovirus 71 vaccine


Chinese vaccines maker Sinovac Biotech Ltd. (Nasdaq: SVA) saw its shares leap 53% to $4.88 in morning…

Asia-PacificEnterovirus 71PharmaceuticalRegulationResearchSinovacVaccines

Daiichi Sankyo updates on PRASFIT-Elective study, NDA filing


Japanese drug major Daiichi Sankyo (TYO: 4568) says that the follow-up period for the Phase III PRASFIT-Elective…

Asia-PacificAspirinCardio-vascularDaiichi SankyoEffientPharmaceuticalprasugrelRegulationResearch

BioAlliance Pharma pursues development plan for Loramyc in Japan through partner Sosei


French orphan oncology and supportive care specialist BioAlliance Pharma (Euronext Paris: BIO) says its…

Antibiotics and Infectious diseasesAsia-PacificBioAlliance PharmaLoramycOravigPharmaceuticalRegulationResearchSosei

Kyowa Hakko set to file for pegfilgrastim approval in Japan following strong Ph III data


Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results…

Asia-PacificBiotechnologyKyowa Hakko KirinOncologypegfilgrastimPharmaceuticalRegulationResearch

Covance gains SFDA GLP Certification for its Shanghai facility; TOT opens new Suzhou plant


USA-based contract research organization (CRO) Covance (NYSE: CVD) says that its early development facility…

Asia-PacificCovancePharmaceuticalProductionRegulationResearchTOT Biopharm

Australia to add Pfizer's Lyrica to PBS list; call for antibiotic research incentives


Australia's Health Minister Tanya Plibersek on Friday announced the government's decision to subsidize…


Drug research in Asia goes native


High recruitment rates and a robust regulatory framework strongly favor the Asian clinical research industry…


Daiichi Sankyo to file prasugrel in Japan next year, following strong results


Japanese drug major Daiichi Sankyo (TYO: 4568) has announced data from the PRASFIT-ACS study, a double-blind…

Asia-PacificCardio-vascularDaiichi SankyoPharmaceuticalprasugrelRegulationResearch

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

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

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

Actelion drops setipiprant, gets miglustat approval in Japan


Switzerland-based Actelion Ltd (SIX: ATLN) announced says that it will re-direct its development efforts…

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

Drug approval and launch for Novartis in China, where Quintiles expands


Swiss drug major Novartis (NOVN: VX) says it has received regulatory approval in China from the State…

Asia-PacificDiabetesGalvusLucentisMarkets & MarketingNovartisOphthalmicsPharmaceuticalQuintilesRegulationResearch

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