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151 to 175 of 305 results

RedHill Biopharma views regulatory pathway for RHB-101 in CHF and hypertension

29-05-2013

Emerging Israeli biopharma company RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive…

BiotechnologyCardio-vascularCarvedilolLicensingPharmaceuticalRedHill BiopharmaRegulationResearchRHB-101

Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth

24-05-2013

At a meeting today with industry analysts, senior leaders from the Janssen pharmaceutical companies of…

FinancialJanssenJohnson & JohnsonPharmaceuticalRegulationResearch

Is failure to adopt business process management putting the pharma industry at risk?

21-05-2013

The dynamic pharmaceutical, biotech and life-science sectors are constantly evolving. With frequent mergers,…

BiotechnologyPharmaceuticalRegulationResearch

Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings

21-05-2013

Global pharmaceutical novel drug approvals will moderate in 2013 due to the exceptional research success…

BiotechnologyGlobalNorth AmericaPharmaceuticalRegulationResearch

Sanofi prepares for regulatory filing of MF candidate on positive JAKARTA study results

17-05-2013

French drug major Sanofi (Euronext: SAN) and NYSE: SNY) this morning (May 17) revealed that the pivotal…

OncologyPharmaceuticalRegulationResearchSanofiSAR302503

Improved voluntary harmonization procedure delivers significant benefits for multinational clinical trials in Europe

16-05-2013

The new Voluntary Harmonization Procedure (VHP), a voluntary procedure agreed by the Clinical Trials…

BiotechnologyEuropePharmaceuticalRegulationResearch

Lilly drops enzastaurin development; Remoxy future viewed by Pfizer and partners

10-05-2013

US drug major Eli Lilly (NYSE: LLY) revealed that Phase III clinical trial results from enzastaurin's…

DurectEli LillyenzastaurinNeurologicalOncologyPain TherapeuticsPfizerPharmaceuticalRegulationRemoxyResearch

Clinical success rates for new cancer drugs doubled from the mid-1990s to early-2000s, says Tufts CSDD

08-05-2013

Clinical success rates for new cancer drugs doubled between the mid-1990s to the early 2000s, while the…

BiotechnologyNorth AmericaOncologyPharmaceuticalRegulationResearch

US FDA grants "Breakthrough" status for AbbVie's HCV regimen

06-05-2013

US drugmaker AbbVie (NYSE: ABBV) says that its investigational direct-acting antiviral (DAA) combination…

AbbVieAnti-viralsPharmaceuticalRegulationResearch

Court stops EMA from disclosing clinical trial documents from AbbVie and InterMune

01-05-2013

The European Medicines Agency has been ordered by the General Court of the European Union not to provide…

AbbVieEuropeInterMuneLegalPharmaceuticalRegulationResearch

European Medicines Agency publishes final advice from clinical trial advisory groups

01-05-2013

The European Medicines Agency yesterday (April 30) published the final advice from the advisory groups…

EuropePharmaceuticalRegulationResearch

Europe falling behind USA and China as attractive for life sciences sector

22-04-2013

Intellectual property specialists Marks & Clerk's latest Life Sciences Report unveils the changing landscape…

BiotechnologyFinancialGlobalPatentsPharmaceuticalRegulationResearch

Sinovac Biotech flu vaccine OKed in Mexico; EV71 results; financials

18-04-2013

In what was a busy news day for Sinovac Biotech (Nasdaq: SVA), a leading provider of vaccines in China,…

BiotechnologyEV71FinancialRegulationResearchSinovac BiotechSouth America

New idiopathic pulmonary fibrosis treatment may open up valuable research opportunity, says GlobalData

17-04-2013

Further research is a prerequisite to shine a light on idiopathic pulmonary fibrosis (IPF) and offer…

BiotechnologyEsbrietInterMunePricingRare diseasesRegulationResearch

Support for introduction of a global regulatory process for biosimilars

16-04-2013

The majority of surveyed US and European physicians and payers are in favor of the introduction of a…

BiotechnologyGenericsGlobalRegulationResearch

US FY 2014 budget continues push to curb patent settlements, shorten biologics exclusivity; a lawyer's view

12-04-2013

At first look, the US Food and Drug Administration appears to have fared rather well under President…

BiotechnologyGenericsNorth AmericaPatentsPoliticsRegulationResearch

EMA reports on patient recruitment and geographical location of clinical trials

10-04-2013

Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs)…

BiotechnologyEuropeGlobalPharmaceuticalRegulationResearch

Pharmacyclics and Janssen gain third FDA "Breakthrough" designation for ibrutinib; new Ph II data

09-04-2013

Pharmacyclics (Nasdaq: PCYC) saw its shares gain 4.5% to $78.96 in early trading Monday, after it revealed…

ibrutinibJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

EMA Board discusses regulatory science and new challenges posed for drug development

26-03-2013

The European Medicines Agency's Management Board held its first meeting in 2013 on March 20-21 March.…

BiotechnologyEuropePharmaceuticalRegulationResearch

Sinovac rockets on strong data for Enterovirus 71 vaccine

15-03-2013

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

14-03-2013

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

Asia-PacificAspirinCardio-vascularDaiichi SankyoEffientPharmaceuticalprasugrelRegulationResearch

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