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EAHP discusses Clinical Trial regulation with Commission, voicing some concerns

09-09-2012

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

EuropePharmaceuticalRegulationResearch

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

06-09-2012

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

DiabetesLucentisNovartisOphthalmicsPharmaceuticalRegulationResearchRoche

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

05-09-2012

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

Anti-viralsBiotechnologyGenfitGFT505RegulationResearch

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

05-09-2012

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

04-09-2012

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

31-08-2012

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

29-08-2012

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

28-08-2012

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

28-08-2012

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

24-08-2012

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

20-08-2012

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

17-08-2012

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

16-08-2012

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

14-08-2012

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

09-08-2012

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

08-08-2012

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

07-08-2012

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

PharmaceuticalRegulationResearch

PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close

07-08-2012

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

02-08-2012

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

01-08-2012

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

25-07-2012

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

18-07-2012

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

BiotechnologyEuropePharmaceuticalRegulationResearch

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

13-07-2012

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

12-07-2012

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

albiglutideDiabetesGlaxoSmithKlineJanuviaMerck & CoPharmaceuticalRegulationResearch

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