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Seattle Genetics earns $6 million milestone under Adcetris accord with Takeda

Seattle Genetics earns $6 million milestone under Adcetris accord with Takeda

08-04-2014

US biotech firm Seattle Genetics says it will receive milestone payments from Japan’s Takeda Pharmaceutical…

AdcetrisAsia-PacificBiotechnologyFinancialMarkets & MarketingOncologySeattle GeneticsSouth AmericaTakeda Pharmaceuticals

Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

Promising emerging agents for triple negative breast cancer

08-04-2014

Due to the heterogeneity of triple negative breast cancer, the most promising emerging agents in development…

Astellas PharmaBiotechnologyMarkets & MarketingMedivationniraparibOncologyTesaroXtandi

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

UK’s ValiRx forms joint venture to fast track lung cancer drug to Phase II

UK’s ValiRx forms joint venture to fast track lung cancer drug to Phase II

08-04-2014

UK biopharmaceutical company ValiRx has established ValiSeek, a joint venture company with Tangent Reprofiling.

Chief executiveLicensingLung cancerOncologyPharmaceuticalResearchScienceUKValiRxValiSeek

GSK faces fresh allegations of “inproper conduct” in Iraq

GSK faces fresh allegations of “inproper conduct” in Iraq

08-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribery in Iraq, less than a year after the…

ChinaGlaxoSmithKlineGSKIraqMajorPharmaceuticalRegulationUK

Pfizer palbociclib trial disappoints, despite meeting primary endpoint

Pfizer palbociclib trial disappoints, despite meeting primary endpoint

08-04-2014

At the American Association of Cancer Research (AACR) Annual Meeting 2014 in San Diego, US pharma giant…

AmgenOncologypalbociclibPfizerPharmaceuticalResearch

Starpharma expands accord with AstraZeneca

Starpharma expands accord with AstraZeneca

07-04-2014

Australian biotech firm Starpharma has signed a second, expanded agreement with Anglo-Swedish drug major…

AstraZenecaBiotechnologyOncologyResearchStarpharma

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Roche in deal with Oryzon to develop epigenetics-based medicines; Buys IQuum

Roche in deal with Oryzon to develop epigenetics-based medicines; Buys IQuum

07-04-2014

Swiss drug major Roche has entered to a worldwide collaboration with Spanish functional genomics firm…

BiotechnologyIQuumLicensingMergers & AcquisitionsOncologyORY-1001Oryzon GenomicsRoche

Safinamide marketing application submitted to Swissmedic

07-04-2014

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

Markets & MarketingNeurologicalNewron PharmaNorthern EuropePharmaceuticalRegulationsafinamideZambon

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

Disappointing results with Amgen’s talimogene laherparepvec in metastatic melanoma

Disappointing results with Amgen’s talimogene laherparepvec in metastatic melanoma

06-04-2014

Leading independent biotech firm Amgen has released mixed top-line results from the primary overall survival…

AmgenBiotechnologyOncologyResearchtalimogene laherparepvec

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

Pharmaceutical companies to benefit from new blood cancer drugs

04-04-2014

Blood cancer drugs represent a growth opportunity for the pharmaceutical industry over the next few years,…

AmgenCelgeneGilead SciencesJohnson & JohnsonMarkets & MarketingOncologyPharmaceuticalRoche

UK’s NICE reverses negative decision on Roche’s Tarceva for NSCLC

04-04-2014

Following a consultation period, the UK drug watchdog the National Institute for Health and Care Excellence…

Northern EuropeOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

Germany’s IQWiG views Xofigo, Kadcyla and Eviplera

03-04-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products, the…

Anti-viralsBayerEvipleraGermanyGilead SciencesKadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheXofigo

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

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