Regulation - Oncology

Filter

Current filters:

Oncology

Popular Filters

469 to 493 of 3429 results

Joint generic drug inspections initiative announced by FDA and EMA

Joint generic drug inspections initiative announced by FDA and EMA

19-12-2013

In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed…

EuropeGenericsNorth AmericaProductionRegulation

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

19-12-2013

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

Brazil’s ANVISA and ProGenericos sign cooperation agreement

Brazil’s ANVISA and ProGenericos sign cooperation agreement

18-12-2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational…

BiosimilarsBrazilGenericsRegulationResearchSouth America

Merck & Co trialing MK-3475 with GSK’s pazopanib in renal cancer

Merck & Co trialing MK-3475 with GSK’s pazopanib in renal cancer

18-12-2013

US pharma giant Merck & Co says it has initiated a clinical trial to evaluate the combination of the…

GlaxoSmithKlineMerck & CoMK-3475OncologyPazopanib TabletsPharmaceuticalResearch

IQWiG view on Roche’s Zelboraf unchanged despite new data

IQWiG view on Roche’s Zelboraf unchanged despite new data

18-12-2013

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major…

EuropeOncologyPharmaceuticalPricingRegulationRocheZelboraf

Pediatric indication for SOBI’s Kineret from UK’s MHRA

Pediatric indication for SOBI’s Kineret from UK’s MHRA

18-12-2013

Kineret (anakinra), from Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI), has been licensed…

BiotechnologyImmunologicalsKineretRegulationSobiUK

EMA Management Board endorses work program for 2014

EMA Management Board endorses work program for 2014

18-12-2013

The European Medicines Agency’s Management Board, at its meeting on December 11-12 adopted the Agency’s…

EuropeFinancialPharmaceuticalRegulation

EMA guidance on publication and access to clinical trial data expected in 2014

EMA guidance on publication and access to clinical trial data expected in 2014

17-12-2013

Discussions on publication and access to clinical trial data are on schedule to be published in 2014…

EuropePharmaceuticalPoliticsRegulation

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

16-12-2013

US antiviral biotech specialist Gilead Sciences says that Health Canada has issued a Notice of Compliance…

Anti-viralsBiotechnologyCanadaGilead SciencesNorth AmericaRegulationsofosbuvirSovaldi

Lack of familiarity with biosimilars among South Korean oncologists

Lack of familiarity with biosimilars among South Korean oncologists

16-12-2013

South Korean oncologists are significantly less familiar with biosimilars than oncologists surveyed in…

Asia-PacificBiosimilarsChinaGenericsOncology

US FDA calls for more data on Janssen’s fixed dose diabetes drug

US FDA calls for more data on Janssen’s fixed dose diabetes drug

16-12-2013

US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug…

canagliflozinDiabetesJanssenJohnson & JohnsonmetforminNorth AmericaPharmaceuticalRegulation

Turkey’s AIFD concerned about counterfeit drugs

Turkey’s AIFD concerned about counterfeit drugs

16-12-2013

Counterfeit drug operations that have been recently uncovered by police raids in various provinces across…

EuropeMarkets & MarketingPharmaceuticalRegulationTurkey

More disappointment for AVEO’s tivozanib in colorectal cancer

More disappointment for AVEO’s tivozanib in colorectal cancer

14-12-2013

There was yet another setback for US biotech firm AVEO Oncology on Friday), when the company announced…

Astellas PharmaAVEO OncologyBiotechnologyOncologyResearch

Positive results Ph II results for AbbVie’s veliparib in breast cancer

Positive results Ph II results for AbbVie’s veliparib in breast cancer

14-12-2013

The I-SPY 2 trial, an innovative, multidrug, Phase II breast cancer study, has yielded positive results…

AbbVieOncologyPharmaceuticalResearchveliparib

US FDA backs new indication for Gilead's Complera

US FDA backs new indication for Gilead's Complera

14-12-2013

US biotech firm Gilead Sciences’ share closed up 1.6% at $71.40 on Friday, following the news of an…

Anti-viralsBiotechnologyCompleraEvipleraGilead SciencesNorth AmericaRegulation

Fast growth forecast for China’s colorectal cancer market

Fast growth forecast for China’s colorectal cancer market

13-12-2013

From 2012 to 2017, the colorectal cancer therapy market in China will grow at an annual rate of 9%, from…

AmgenAsia-PacificBayerIndiaMarkets & MarketingOncologyPharmaceuticalSanofiStivargaVectibixZaltrap

SABCS 2013: Arimidex cuts breast cancer risk 53% in high risk women

SABCS 2013: Arimidex cuts breast cancer risk 53% in high risk women

13-12-2013

A study of 4,000 women found that anastrozole, Anglo-Swedish drug major AstraZeneca’s now off-patent…

AnastrozoleArimidexAstraZenecaOncologyPharmaceuticalResearchtamoxifen

OncoMed CEO presses for better environment for biopharma innovation, at House hearings

13-12-2013

The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

469 to 493 of 3429 results

Back to top