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AHF demands FDA reversal on use of Gilead's HIV prevention pill for women

06-03-2013

Citing another failed clinical trial in women of the use of Gilead Sciences' (Nasdaq: GILD) AIDS drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationResearchTruvada

ABPI announces new clinical trial transparency measures

01-03-2013

The Association of the British Pharmaceutical Industry Association (ABPI) has said that it will put in…

EuropePharmaceuticalRegulationResearch

UK government moves to cut red tape to benefit R&D for new drugs

27-02-2013

The UK government yesterday announced a change to the Patents Act which will help the UK's world class…

BiotechnologyEuropePatentsPharmaceuticalRegulationResearch

FDA suspends pediatric trial of Amgen's Sensipar after patient death

27-02-2013

The US Food and Drug Administration revealed yesterday that it has stopped all pediatric clinical trials…

AmgenBiotechnologyRegulationResearchSensipar

OECD urges harmonization of clinical trial regulations to boost medical R&D

25-02-2013

Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and…

BiotechnologyGlobalPharmaceuticalRegulationResearch

Genentech Ph III study of omalizumab shows promise in CIU

25-02-2013

Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase…

BiotechnologyDermatologicalsGenentechNovartisOmalizumabPharmaceuticalRegulationResearchRespiratory and PulmonaryRocheXolair

US FDA grants "breakthrough" status for Janssen and Pharmacyclics ibrutinib

14-02-2013

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, says that…

BiotechnologyibrutinibJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

FDA guidance on developing Alzheimer's could ease barriers to research

11-02-2013

The US Food and Drug Administration last week issued a proposal designed to assist companies developing…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

Kyowa Hakko set to file for pegfilgrastim approval in Japan following strong Ph III data

28-01-2013

Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results…

Asia-PacificBiotechnologyKyowa Hakko KirinOncologypegfilgrastimPharmaceuticalRegulationResearch

Tufts CSDD says drug developers need to identify and address root causes of R&D inefficiency

09-01-2013

While patent expirations on many top selling medicines is spurring the research-based drug industry to…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

Merck & Co to drop Tredaptive development in USA

21-12-2012

US drug giant Merck & Co (NYSE: MRK) said yesterday that, following disappointing clinical trial results…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptive

Covance gains SFDA GLP Certification for its Shanghai facility; TOT opens new Suzhou plant

05-12-2012

USA-based contract research organization (CRO) Covance (NYSE: CVD) says that its early development facility…

Asia-PacificCovancePharmaceuticalProductionRegulationResearchTOT Biopharm

Revised EPHA position on clinical trials

03-12-2012

The European Public Health Alliance (EPHA) has revised its position on clinical trials following the…

EuropePharmaceuticalRegulationResearch

Structural defects holding back growth of Russia's pharmaceutical industry

03-12-2012

Despite having grown significant since 2009 and set to be worth $10.7 million by 2014, there are some…

EuropeMarkets & MarketingPharmaceuticalRegulationResearch

EMA workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data

26-11-2012

"The European Medicines Agency is committed to proactive publication of clinical-trial data, once the…

BiotechnologyEuropePatentsPharmaceuticalRegulationResearch

Zealand Pharma valuation hinged on Lyxi/Lanti "fixflex"

23-11-2012

The recent European Medicine Agency advisory committee, CHMP, positive opinion for French drug major…

BiotechnologyDiabetesFinancialLantusLyxumiaNovo NordiskRegulationResearchSanofiTresibaVictozaZealand Pharma

"Joined-up" approach needed in UK to deliver life sciences strategy

22-11-2012

A report published yesterday by IMS Health - which shows the slow progress being made on the uptake of…

EuropeHealthcarePharmaceuticalPoliticsRegulationResearch

Australia to add Pfizer's Lyrica to PBS list; call for antibiotic research incentives

18-11-2012

Australia's Health Minister Tanya Plibersek on Friday announced the government's decision to subsidize…

Asia-PacificLyricaPfizerPharmaceuticalPricingRegulationResearch

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