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SkyePharma partner Kyorin completes Japanese Flutiform clinical program

26-06-2012

UK drug delivery specialist SkyePharma (LSE: SKP) saw its shares leap nearly 11% to £76.50 last…

Asia-PacificFlutiformKyorin PharmaceuticalsPharmaceuticalRegulationResearchRespiratory and PulmonarySkyepharma

Issues to be navigated to unleash full potential of stem cell therapies

18-06-2012

Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research…

BiotechnologyPharmaceuticalPricingRegulationResearch

Value of new cancer medicines to patients evolve overtime, PhRMA report shows

13-06-2012

Following Food and Drug Administration approval of a new cancer medicine, it often takes years of additional…

BiotechnologyNorth AmericaOncologyPharmaceuticalRegulationResearch

More guidelines needed to grow regenerative medicine market, report finds

11-06-2012

Standardized research guidelines are needed to control and encourage the development of gene therapy…

BiotechnologyFinancialGlobalPoliticsRegulationResearch

EU Ombudsman wants more transparency concerning medicines for children

04-06-2012

European Union Ombudsman Nikiforos Diamandouros has called on the European Medicines Agency to increase…

AstraZenecaCandesartan CilexetilCardio-vascularEuropePharmaceuticalRegulationResearchTakeda Pharmaceuticals

UK health and life sciences group agrees new clinical trials transparency principles

28-05-2012

The Ethical Standards in Health and Life Sciences Group (ESHLSG), a partnership including the Association…

BiotechnologyEuropePharmaceuticalRegulationResearch

News briefs: GlaxoSmithKline and Bayer

24-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) has said it would not proceed with its $2.59 billion hostile…

Antibiotics and Infectious diseasesBayerGlaxoSmithKlineMergers & AcquisitionsOncologyPharmaceuticalregorafenibRegulationResearch

Optimism and concerns of Netherlands' Biotech industry

17-05-2012

Major trends and developments in the Dutch biotechnology sector, mainly based on the expectations voiced…

BiotechnologyEuropeFinancialRegulationResearch

Lundbeck and Takeda to file for Lu AA21004 approval in USA and Europe on strong Ph III results

15-05-2012

Danish CNS drug specialist Lundbeck A/S (LUND: DC) yesterday announced positive top-line results from…

Lu AA21004LundbeckNeurologicalPharmaceuticalRegulationResearchTakeda Pharmaceuticals

UK's Proximagen boosted by US lorcaserin news with respect to its own obesity drug candidate

14-05-2012

UK-based biotechnology firm Proximagen (AIM: PRX) saw its shares leap 20.1% to 257.5 pence, on the back…

BiotechnologyMetabolicsProximagenRegulationResearch

US FDA warns on safety of Celgene's Revlimid; new Ph III trial results

11-05-2012

The US Food and Drug Administration this week issued a notification of an increased risk of second primary…

BiotechnologyCelgeneOncologyRegulationResearchRevlimid

Sandoz to emphasize need for consistent regulatory standards across all biologics at FDA hearings

10-05-2012

Germany-based Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) announced that Mark McCamish,…

BiotechnologyGeneralNorth AmericaNovartisRegulationResearchSandoz

Patient perspectives influencing drug development

02-05-2012

Support is growing for increased collaboration between pharmaceutical companies and patients in research…

BiotechnologyPharmaceuticalRegulationResearch

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal

23-04-2012

Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Novartis makes Tekturna label change, updates on Gilenya and stops alisporivir trial

20-04-2012

In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated…

alisporivirAnti-viralsCardio-vascularGilenyaNeurologicalNovartisPharmaceuticalRegulationResearchTekturna

Towards a robust global framework for conduct and oversight of clinical trials in EU

18-04-2012

The European Medicines Agency has published the final reflection paper on ethical and good clinical practice…

BiotechnologyEuropePharmaceuticalRegulationResearch

European regulators see way forward for publication of full clinical trial data

12-04-2012

A group of European regulators have set out a way forward for the publication of the results of clinical…

EuropePharmaceuticalRegulationResearch

Victoza US label update includes superior efficacy over Januvia, says Novo Nordisk

10-04-2012

The US Food and Drug Administration has approved an update to the product label for Victoza (liraglutide…

DiabetesJanuviaLevemirMerck & CoNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Sanofi and Regeneron mCRC drug Zaltrap misses goals but gets FDA priority

10-04-2012

The US Food and Drug Administration has granted priority review of the Biologics License Application…

BiotechnologyNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiZaltrap

Actelion drops setipiprant, gets miglustat approval in Japan

04-04-2012

Switzerland-based Actelion Ltd (SIX: ATLN) announced says that it will re-direct its development efforts…

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

Bayer cancer drug candidate regorafenib improves survival in GIST

04-04-2012

German drug major Bayer (BAY: DE) yesterday announced positive results from its Phase III trial GRID…

BayerOncologyPharmaceuticalregorafenibRegulationResearch

Roche to file for trastuzumab emtansine this year, on positive Ph III results

03-04-2012

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III…

BiotechnologyGenentechGlaxoSmithKlineOncologyPharmaceuticalRegulationResearchRochetrastuzumab

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