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EAHP discusses Clinical Trial regulation with Commission, voicing some concerns


The European Association of Hospital Pharmacists (EAHP) last week met with officials at the European…


Safety of Novartis' Lucentis in VI-DME confirmed with new data; efficacy in CNV


New data revealed yesterday by Swiss drug major Novartis (NOVN: VX) showed that Lucentis (ranibizumab)…


FDA approves initiation of a Phase IIb study of Genfit's GFT505


French biotech firm Genfit (Alternext: ALGFT) says that the US Food and Drug Administration has approved…


Oncology drugs get faster approvals than non-cancer drugs in USA, but opposite case in Europe, Tufts research finds


Approval times for new oncology drugs in the USA during the last decade were shorter than those for non-oncology…

BiotechnologyEuropeNorth AmericaOncologyPharmaceuticalRegulationResearch

Headache for Pharma as R&D spending climbs while NME approvals fall


Low research and development (R&D) productivity, combined with the patent cliff and a stringent US Food…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

Novartis set to file QVA149 filing in EU and Japan by end of year


Swiss drug major Novartis announced yesterday that the fifth QVA149 (indacaterol maleate/glycopyrronium…

NovartisPharmaceuticalQVA149RegulationResearchRespiratory and PulmonarySeebri BreezhalerVectura

Genentech's T-DM1 significantly improved survival for metastatic breast cancer patients


Swiss drug major Roche (ROG: SIX) US subsidiary Genentech has announced updated results from the Phase…

BiotechnologyGenentechOncologyPharmaceuticalRegulationResearchRocheT-DM1trastuzumab emtansine

GSK completes LAMA/LABA Ph III program; readies for global filings


UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) say they have completed…

GlaxoSmithKlinePharmaceuticalRegulationResearchRespiratory and PulmonaryTheravanceumeclidiniumvilanterol

Merck & Co to file for approval of two heart drugs next year


US drugs giant Merck & Co (NYSE: MRK) says that, following a review of the clinical trial data and discussions…

anacetrapibCardio-vascularEuropeMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptivevorapaxar

Bristol-Myers drops hep C pill on patient safety issues


US drug major Bristol-Myers Squibb (NYSE: BMY) has discontinued development of BMS-986094 (formerly known…

Anti-viralsBiotechnologyBMS-986094Bristol-Myers SquibbPharmaceuticalRegulationResearch

New approaches for evaluating benefits and risks of obesity drugs from QW


The USA's George Washington University School of Public Health and Health Services (GW) has released…

HealthcareMetabolicsNorth AmericaPharmaceuticalRegulationResearch

Idenix plunges as FDA puts clinical hold on hepatitis C drug candidate


US biotech firm Idenix Pharmaceuticals (Nasdaq: IDIX) saw its shares tank 29% to $5.91 in morning trading…

Anti-viralsBiotechnologyIdenix PharmaceuticalsIDX184North AmericaPharmaceuticalRegulationResearch

FDA calls for Biovest to conduct another Ph III trial of BiovaxID in NHL


US biotech firm Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals…

BiotechnologyBiovaxIDBiovest InternationalOncologyRegulationResearch

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

US health care reform looks to squeeze players up and down the value chain


This summer's landmark Supreme Court decision to uphold the USA's Patient Privacy and Affordable Care…

BiotechnologyFinancialHealthcareNorth AmericaPharmaceuticalRegulationResearch

Pluristem cleared to start Phase I/II PLX cell study for muscle regeneration in Germany


In a second piece of good news this week, Israeli biotech company Pluristem Therapeutics (TASE: PLTR)…

BiotechnologyEuropePluristem TherapeuticsPLX cellsRegulationResearch

Links with academia changing way Pharma does science, says Tufts CSDD


Drug developers are forging new ways to work with academic medical centers to create the next generation…


PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close


The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date…

Astellas PharmaenzalutamideGenito-urinaryMedivationOncologyPharmaceuticalRegulationResearchUrogenixVaccines

News briefs: setbacks for B-MS hep C drug; Baxter's HyQ


US drug major Bristol-Myers Squibb (NYSE: BMY) has suspended study drug administration in ongoing Phase…

Anti-viralsBaxter InternationalBMS-986094Bristol-Myers SquibbHyQImmunologicalsNorth AmericaPharmaceuticalRegulationResearch

Positive new data for Pfizer's tofacitinib; possible regulatory delay


Pfizer (NYSE:PFE), the world's largest drugmaker by sales, yesterday released positive top-line results…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationResearchtofacitinib

Sanofi Pasteur's dengue vaccine proves effective and safe; FDA identifies cGMP deviations


French drug major Sanofi (Euronext: SAN) vaccines subsidiary Sanofi Pasteur sais this morning that its…

PharmaceuticalRegulationResearchSanofiSanofi PasteurTropical diseasesVaccines

EU Commission proposes to revamp rules on clinical trials to make Europe more attractive for research


With the aim of boosting clinical research in Europe by simplifying the rules for conducting clinical…


Merck & Co closes odanacatib trial early on good results in osteoporosis


US drug giant Merck & Co (NYSE: MRK) says it is halting a Phase III trial of its investigational osteoporosis…

Anti-Arthritics/RheumaticsMerck & CoodanacatibPharmaceuticalRegulationResearch

GlaxoSmithKline readies for filing of diabetes drug albiglutide on positive final data


UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study…

albiglutideDiabetesGlaxoSmithKlineJanuviaMerck & CoPharmaceuticalRegulationResearch

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