Regulation

Filter

Current filters:

None

Popular Filters

2370 to 2394 of 2609 results

EMA guidelines on pharmacogenetics in evaluating pharmacokinetics of medicines

12-02-2012

The European Medicines Agency on Friday published a guideline advising pharmaceutical companies how to…

BiotechnologyEuropePharmaceuticalRegulationResearch

At last, draft guidance on biosimilars pathway from US FDA

10-02-2012

Coming somewhat behind European Union action, the US Food and Drug Administration late yesterday issued…

BiotechnologyGenericsNorth AmericaRegulation

Shire forecasts strong 2012 EPS growth on record 2011 sales; Vyvanse news

10-02-2012

Shire (LSE: SHP), the UK’s third-largest drugmaker, posted a pleasing set of financial for full-year…

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

Global peptic ulcer market forecast to reach $1.05 billion by 2018; FDA warns on PPIs

09-02-2012

The global peptic ulcer therapeutics market was worth $892.4 million in 2010, and is forecast to grow…

Gastro-intestinalsMarkets & MarketingPharmaceuticalRegulation

Amgen fails to get FDA advisory backing for extended use of Xgeva

09-02-2012

The world’s largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food…

AmgenBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationXgeva

GW Pharma’s Sativex cleared in Austria

07-02-2012

The UK’s GW Pharmaceuticals’ (AIM: GWP) Sativex (delta-9-tetrahydrocannabinol (THC) and cannabidiol…

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalRegulationSativex

Another FDA hurdle for Orexigen obesity drug candidate

07-02-2012

It might seem to some that the US Food and Drug Administration has no intentions of approving any new…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

Merck & Co confirms NDA filing for suvorexant in 2012

07-02-2012

US drugs giant Merck & Co (NYSE: MRK) yesterday provided an update on the development program for suvorexant,…

Merck & CoNeurologicalNorth AmericaPharmaceuticalRegulationResearchsuvorexant

Reinventing biopharma: Strategies for an evolving marketplace

07-02-2012

The biopharmaceutical industry today is facing a multifaceted “value challenge”. It is no longer…

BiotechnologyGlobalMarkets & MarketingPharmaceuticalPricingRegulation

New bipartisan legislation to address US drug shortages

06-02-2012

US Representatives John Carney (Democrat, Delaware) and Larry Bucshon (Republican, Indian) last week…

GenericsLegalNorth AmericaPharmaceuticalRegulation

EMA planning fundamental change in pharmacovigilance rules

03-02-2012

The European Medicines Agency, together with the European Union member states and the European Commission,…

BiotechnologyEuropePharmaceuticalRegulation

NICE issues negative guidance for Zytiga

02-02-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued new draft…

EuropeJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationZytiga

FDA approves combo diabetes drug Jentadueto and Kalydeco

01-02-2012

The US Food and Drug Administration) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets,…

Boehringer IngelheimDiabetesEli LillyJentaduetoKalydecolinagliptinNorth AmericaPharmaceuticalRare diseasesRegulationVertex

Two hurdles to jump for SkyePharma, as it changes CEO

31-01-2012

On the same day that UK-based SkyePharma (LSE: SKP) announced that Axel Mueller has resigned as chief…

3MEuropeFinancialFlutiformManagementPharmaceuticalRegulationRespiratory and PulmonarySkyepharma

Allos Thera questions CHMP Folotyn decision; posts new data

31-01-2012

USA-based Allos Therapeutics, Inc. (Nasdaq: ALTH) says that it has submitted a request to the European…

Allos TherapeuticsEuropeFolotynOncologyPharmaceuticalRegulationResearch

PhRMA transitions management of BRAT framework to CIRS

31-01-2012

The Pharmaceutical Research and Manufacturers of America (PhRMA) says it has transferred its Benefit-Risk…

North AmericaPharmaceuticalRegulationResearch

Faster-than-expected FDA approval of Roche’s vismodegib

31-01-2012

There was good news for Swiss drug major Roche's (ROG: SIX)subsidiary Genentech yesterday, when it received…

BiotechnologyCurisErivedgeGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

Cell Therapeutics updates on Pixuvri

30-01-2012

Seattle, USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has voluntarily withdrawn its…

BiotechnologyCell TherapeuticsNorth AmericaOncologyPixuvriRegulation

Irish pharma sees failures in ESRI report on use of pharmaceuticals

30-01-2012

A new report by Ireland’s Economic and Social Research Institute (ESRI) has recommended new ways…

BiotechnologyEuropePharmaceuticalPricingRegulation

FDA finally approves Bydureon

30-01-2012

There was good news on Friday for USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) and Alkermes (Nasdaq:…

AlkermesAmylinBydureonDiabetesEli LillyNorth AmericaPharmaceuticalRegulation

EC and Italian government seek to boost generic medicine use

30-01-2012

The European Commission’s formal call last week on Italy to comply with European Union rules on…

EuropeGenericsMarkets & MarketingPatentsPharmaceuticalPoliticsRegulation

FDA OKs Pfizer’s Inlyta and accepts NDA for bosutinib

30-01-2012

The US Food and Drug Administration on Friday approved global pharma behemoth Pfizer’s (NYSE: PFE)…

bosutinibInlytaNorth AmericaOncologyPfizerPharmaceuticalRegulation

2370 to 2394 of 2609 results

Back to top