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2332 to 2356 of 2579 results

Revisions to Code of Marketing for Ireland’s pharma

12-01-2012

The Irish Pharmaceutical Healthcare Association (IPHA) this week announced the introduction of a revised…

EuropeMarkets & MarketingPharmaceuticalRegulation

US ANDAs filed for generic Beyaz, Isentress and Epivir

12-01-2012

The US Food and Drug Administration says that Abbreviated New Drug Applications have been received by…

Anti-viralsBayerBeyazEpivirGenericsGlaxoSmithKlineIsentressMerck & CoPharmaceuticalRegulationReproductive

Negative NICE guidance for Sanofi prostate cancer drug

12-01-2012

The UK’s drug watchdog the National Institute for Health and Clinical Excellence (NICE), has today…

EuropeJevtanaOncologyPharmaceuticalPricingRegulationSanofi

Threats to US biomedical industry viewed by CEOs

12-01-2012

Access to capital, a burdensome and uncertain regulatory environment and lack of innovation and productivity…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulationResearch

EMA opens public consultation on cancer drugs evaluation

11-01-2012

A public consultation on the revised guideline on the evaluation of human anticancer medicines has been…

BiotechnologyEuropeOncologyPharmaceuticalRegulation

FDA updates on obesity drug candidates

11-01-2012

There have been two pieces of positive news coming out of the US Food and Drug Administration this week…

Arena PharmaceuticalsEisailorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

EC backs continued use of pioglitazone drugs for diabetes

10-01-2012

Japan’s largest drugmaker, Takeda Pharmaceutical (TYO 4502) said yesterday that the European Commission…

ActosDiabetesEuropePharmaceuticalPioglitazoneRegulationTakeda Pharmaceuticals

GSK and Theravance to file COPD/asthma drug

10-01-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and partner USA-based Theravance (Nasdaq: THRX), in which…

GlaxoSmithKlinePharmaceuticalRegulationRelovairResearchRespiratory and PulmonaryTheravance

NICE calls for more data on Xarelto; Bayer files for added indication

10-01-2012

In preliminary recommendations published yesterday (January 9) the UK’s drugs watchdog the National…

BayerCardio-vascularEuropePharmaceuticalRegulationXarelto

Added benefit of Trajenta not proven, says German agency

10-01-2012

In an early benefit assessment under Germany’s "Act on the Reform of the Market for Medicinal Products”…

Boehringer IngelheimDiabetesEli LillyEuropePharmaceuticalRegulationTrajenta

Vertex plans for Kalydeco launch

09-01-2012

US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) announced its 2012 business objectives in conjunction…

Anti-viralsIncivekKalydecoPharmaceuticalRare diseasesRegulationResearchVertex

J&J’s Zytiga offers considerable added benefit in certain patients

09-01-2012

US health care giant Johnson & Johnson’s Zytiga (abiraterone) was approved in Europe last fall for…

Johnson & JohnsonOncologyPharmaceuticalRegulationResearchZytiga

“Size Matters,” says FDA, when it comes to generic drug-RLD sameness

08-01-2012

In what appears to be a further sign of the US Food and Drug Administration’s efforts to clamp down…

GenericsNorth AmericaRegulation

USP proposals for supply chain assurance and help reduce counterfeiting

08-01-2012

In an effort to encourage comprehensive public standards across the pharmaceutical industry, the US Pharmacopeial…

North AmericaPharmaceuticalRegulation

European Medicines Agency releases adverse reaction report

05-01-2012

European Ombudsman Nikiforos Diamandouros has welcomed the European Medicines Agency's release of adverse…

Antibiotics and Infectious diseasesEuropePharmaceuticalRegulation

Arena files complete response on lorcaserin

05-01-2012

In another attempt to gain approval for its obesity drug candidate that was turned down by US regulators…

Arena PharmaceuticalsEisailorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulationResearch

FDA OKs generic Ritalin for Actavis and Mylan’s Keppra

04-01-2012

Iceland-based generic drugmaker Actavis says that it recently received approval from the US Food and…

ActavisGenericsKeppra XRMylan LaboratoriesNeurologicalRegulationRitalin LA

FDA advisory to review Cell Thera’s re-submitted pixantrone NDA

03-01-2012

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review Cell Therapeutics’…

Cell TherapeuticsNorth AmericaOncologyPharmaceuticalpixantronePixuvriRegulation

Biotech predictions for 2012 from sector specialist Steven Burrill

03-01-2012

As 2011 drew to a close, Steven Burrill, chief executive of global life sciences financial services firm…

BiotechnologyFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegulation

Expanded use for Pfizer’s Prevnar 13

03-01-2012

Following a previous US Food and Drug Administration advisory panel recommendation (The Pharma Letter…

North AmericaPfizerPharmaceuticalPrevnarRegulationVaccines

Eisai re-submits perampanel NDA; FDA accepts Gilead’s Quad

28-12-2011

Japanese drug major Eisai (TYO: 4523) says that it has re-submitted the New Drug Application (NDA) for…

Anti-viralsEisaiGilead SciencesNeurologicalperampanelPharmaceuticalQuadRegulation

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