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


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

BiotechnologyGlobalNorth AmericaPharmaceuticalRegulationResearch

Germany's G-BA issues final assessment for Cell Thera's Pixuvri


USA-based Cell Therapeutics (Nasdaq: CTIC) says that Germany's Federal Joint Committee (G-BA) has issued…

BiotechnologyCell TherapeuticsEuropeOncologyPharmaceuticalPixuvriPricingRegulation

HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst


While the risks involved in HIV vaccine development have turned Big Pharma away from pursuing a preventative…

Anti-viralsBiotechnologyFinancialHVTN 505PharmaceuticalResearchVaccines

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


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


Australia's revised code to benefit ASX-listed life science companies


Australia's Minister for Technology, Gordon Rich-Phillips, this week joined forces with the Australian…


Merck Serono Ph III trial of L-BLP25 fails endpoint in NSCLC


Merck Serono, a division of Germany's Merck KGaA (MRK: DE), announced detailed results from the randomized…

BiotechnologyL-BLP25Merck KGaAMerck SeronoOncologyPharmaceuticalResearchStimuvax

US FDA approves Janssen's Simponi to treat ulcerative colitis


The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson…

BiotechnologyGastro-intestinalsInflammatory diseasesJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

US Senate confirms appointment of Marilyn Tavenner as CMS Administrator


US Health and Human Services (HHS) Secretary Kathleen Sebelius announced that the US Senate has confirmed…

BiotechnologyGenericsHealthcareManagementNorth AmericaPharmaceutical

Merck Serono and Quintiles enter novel clinical development partnership


Merck Serono, the biotech division of Germany's Merck KGaA (MRK: DE) and Quintiles (NYSE: Q) have announced…

BiotechnologyMerck KGaAMerck SeronoPharmaceuticalQuintilesResearch

AstraZeneca plans to move three cancer drug candidates into Ph III


Anglo-Swedish drug major AstraZeneca (LSE: AZN) this morning (May 16) announced that it will be moving…

AstraZenecaBiotechnologyMedImmunemoxetumomab pasudotoxolaparibOncologyPharmaceuticalResearchselumetinib

Encouraging results with Sangamo's SB-728-T in HIV treatment


USA-based Sangamo BioSciences (Nasdaq: SGMO) has presented new clinical data from its program to develop…


FDA approves Theravance and GSK's Breo Ellipta to treat COPD


The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an…

BiotechnologyBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySkyepharmaTheravance Biopharma

Cancer treatments "unaffordable" and will drive rapid transition to generics and market decline, says GlobalData


The rising prices of new cancer drugs are resulting in an increasing cost burden for patients and health…

BiotechnologyGenericsGlobalMarkets & MarketingOncologyPharmaceuticalPricing

European Medicines Agency simplifies processing of fee reductions for orphan medicines


The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan…

BiotechnologyEuropeFinancialPharmaceuticalRare diseasesRegulation

US FDA accepts Merck & Co's BLA ragweed pollen allergy immunotherapy


US pharma giant Merck & Co (NYSE: MRK) revealed yesterday (May 8) that the Biologics License Application…

Alk-AbelloBiotechnologyImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

MoCA report a welcome stepping stone, but access to orphan medicines remains unfinished business, say trade groups


The three leading pharma/biotech trade bodies, EuropaBio, the European Federation of Pharmaceutical Industries…

BiotechnologyEuropeHealthcarePharmaceuticalPoliticsRare diseasesRegulation

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


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

BiotechnologyNorth AmericaOncologyPharmaceuticalRegulationResearch

BioCity to develop BioHub at Alderley Park post AstraZeneca


BioCity Nottingham, a UK provider of life sciences business incubation services, has been appointed by…


Bristol-Myers gets added indication from US FDA for Sustiva; signs second deal with Ambrx


US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved…

AmbrxAnti-viralsBiotechnologyBristol-Myers SquibbCardio-vascularDiabetesLicensingNorth AmericaPharmaceuticalRegulationSustiva

Regeneron acquires rights to two ophthalmology programs from Sanofi


US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) has expanded its ophthalmology portfolio by…


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