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

21-05-2013

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

20-05-2013

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

16-05-2013

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

BiotechnologyEuropePharmaceuticalRegulationResearch

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

16-05-2013

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

Asia-PacificBiotechnologyFinancialPharmaceuticalRegulation

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

16-05-2013

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

16-05-2013

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

16-05-2013

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

16-05-2013

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

16-05-2013

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

15-05-2013

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

Anti-viralsBiotechnologyPharmaceuticalResearch

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

13-05-2013

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

10-05-2013

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

09-05-2013

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

09-05-2013

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

09-05-2013

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

08-05-2013

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

07-05-2013

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

AstraZenecaBiotechnologyEuropePharmaceuticalResearch

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

06-05-2013

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

03-05-2013

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

BiotechnologyEyleaFinancialLicensingOphthalmicsPharmaceuticalRegeneronSanofi

Acceleron and Shire not to restart ACE-031 program

03-05-2013

Privately-held US biotech firm Acceleron Pharma says that Ireland-headquartered Shire (LSE: SHP) has…

Acceleron PharmaACE-031BiotechnologyLicensingPharmaceuticalRare diseasesResearchShire

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