Regulation - Oncology

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Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

European approval for expanded use of Celgene’s Revlimid

20-02-2015

US biotech firm Celgene’s European subsidiary has received approval from the European Commission for…

BiotechnologyCelgene CorpEuropeOncologyRegulationRevlimid

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

17-02-2015

Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US…

Bexion PharmaceuticalsBiotechnologyBXQ-350OncologyRegulationSaposin CUSA

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

14-02-2015

The US Food and Drug Administration on Friday granted approval for Japanese pharma major Eisai’s Lenvima…

BanzelEisailenvatinibLenvimaNeurologicalOncologyPharmaceuticalRare diseasesRegulationUSA

NICE final draft guidance does not recommend pomalidomide for blood cancer

NICE final draft guidance does not recommend pomalidomide for blood cancer

13-02-2015

The England medical costs watchdog the National Institute for Health and Care excellence (NICE) has issued…

BiotechnologyCelgene CorpImnovidOncologypomalidomidePricingRegulationUK

Breckenridge Pharma files ANDA for generic of Sanofi’s Jevtana

12-02-2015

Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application…

Breckenridge PharmaceuticalsGenericsJevtanaOncologyPatentsRegulationSanofiUSA

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

10-02-2015

US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner…

BayerGenericsLegalMylanNexavarOncologyOnyx PharmaceuticalsPatentsPatents & Trade marksRegulationUSA

Celgene's Abraxane recommended by Scottish Medicines Consortium

Celgene's Abraxane recommended by Scottish Medicines Consortium

10-02-2015

The Scottish Medicines Consortium has decided to recommend Abraxane (paclitaxel) in combination with…

AbraxaneBiotechnologyCelgene CorpOncologyRegulationUK

Janssen disappointed at SMC decision on Zytiga

09-02-2015

Janssen, a UK-based subsidiary of US health care giant Johnson & Johnson is disappointed with the Scottish…

JanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationUKZytiga

European Commission approves added indication for Janssen’s Velcade, in MCL

European Commission approves added indication for Janssen’s Velcade, in MCL

06-02-2015

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV (Janssen)…

BiotechnologyEuropeJanssen-Cilag InternationalJohnson & JohnsonOncologyRegulationVelcade

IQWiG finds no added benefit for Latuda in schizophrenia

IQWiG finds no added benefit for Latuda in schizophrenia

06-02-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination…

GermanyLatudaOncologyPharmaceuticalPricingRegulationSumitomo DainipponTakeda Pharmaceutical

Early FDA approval for Pfizer breast cancer drug Ibrance

Early FDA approval for Pfizer breast cancer drug Ibrance

04-02-2015

The US Food and Drug Administration yesterday granted accelerated approval for pharma giant Pfizer’s…

IbranceOncologyPfizerPharmaceuticalRegulationUSA

Novartis' Japan unit faces 15-day suspension over trial data manipulation

Novartis' Japan unit faces 15-day suspension over trial data manipulation

04-02-2015

The Japanese unit of Swiss drug major Novartis is facing suspension following allegations of data manipulation…

DiovanHematologyJapanLegalNovartis PharmaceuticalsOncologyPharmaceuticalRegulation

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

28-01-2015

USA-based Amgen, the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals…

AmgenKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulationUSA

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

IQWiG reports negative views on Provenge, Velphoro and Zydelig

IQWiG reports negative views on Provenge, Velphoro and Zydelig

22-01-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers…

DendreonGermanyGilead SciencesNephrology and HepatologyOncologyPharmaceuticalPricingProvengeRegulationVelphoroVifor PharmaZydelig

Ariad gets positive final EC decision on Iclusig

20-01-2015

USA-based Ariad Pharmaceuticals today revealed that the European Commission has endorsed the final opinion…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

FDA removes hold on CytRx's aldoxorubicin Phase III trials

FDA removes hold on CytRx's aldoxorubicin Phase III trials

20-01-2015

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company…

aldoxorubicinBiotechnologyCytRxOncologyRegulationResearchUSA

Merck & Co updates on plans to accelerate new drug submissions and future growth

Merck & Co updates on plans to accelerate new drug submissions and future growth

13-01-2015

US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative…

Anti-viralsgrazoprevir/elbasvirKeytrudaMerck & CoOncologyPharmaceuticalRegulationResearchUSA

Cost to NHS of Provenge too high to be recommended, says NICE

13-01-2015

England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

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