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FDA backs Janssen’s Sylvant for rare disease

24-04-2014

The US Food and Drug Administration yesterday approved Johnson & Johnson subsidiary Janssen Biotech’s…

Janssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximabSylvantUSA

Lilly's Cyramza first FDA-approved drug for advanced gastric cancer after prior chemo

22-04-2014

The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as…

CyramzaEli LillyNorth AmericaOncologyPharmaceuticalRegulationUSA

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

Express Scripts forecasts unsustainable increases in specialty drug spend in USA

Express Scripts forecasts unsustainable increases in specialty drug spend in USA

09-04-2014

Expensive treatments for broad patient populations are driving unprecedented growth in US spending on…

Anti-Arthritics/RheumaticsAnti-viralsMarkets & MarketingNorth AmericaOncologyPharmaceuticalPricingUSA

Lilly's Alimta patent upheld through 2022

Lilly's Alimta patent upheld through 2022

01-04-2014

US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled…

AlimtaEli LillyLegalNorth AmericaOncologyPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication

18-03-2014

Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Heron Therapeutics says timeline for Sustol resubmission delayed

28-01-2014

US specialty pharma group Heron Therapeutics saw its shares plunge after the company revealed an around…

Heron TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationSustolUSA

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

Six US research institutions get $540 million funding from Ludwig Cancer Research

06-01-2014

Cancer research in the US received a critical boost as the six Ludwig Centers at Johns Hopkins University,…

FinancialNorth AmericaOncologyPharmaceuticalResearchUSA

FDA clears resumption of Iclusig sales in USA

FDA clears resumption of Iclusig sales in USA

22-12-2013

The US Food and Drug Administration has approved a revised US Prescribing Information and a Risk Evaluation…

North AmericaOncologyPharmaceuticalRegulation

Teva gains additional regulatory exclusivity for Treanda

Teva gains additional regulatory exclusivity for Treanda

28-11-2013

Israel-based global generic giant Teva Pharmaceutical Industries has been granted orphan drug exclusivity…

North AmericaOncologyPharmaceuticalRegulationTeva Pharmaceutical IndustriesTreanda

US patient share leaders in first-line BRAF-mutation positive malignant melanoma

27-11-2013

According to US oncologists surveyed in the third quarter of 2013 by BioTrends Research, a unit of Decision…

Bristol-Myers SquibbGlaxoSmithKlineMarkets & MarketingMekinistNorth AmericaOncologyPharmaceuticalRocheTafinlarYervoyZelboraf

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan

23-11-2013

There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Pfizer’s Xalkori gains regular FDA approval for NSCLC

Pfizer’s Xalkori gains regular FDA approval for NSCLC

22-11-2013

The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori…

North AmericaOncologyPfizerPharmaceuticalRegulationXalkori

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

14-11-2013

The US Food and Drug Administration yesterday approved US health care giant Johnson & Johnson’s Imbruvica…

ibrutinibImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclics

Liver cancer market to nearly treble in size to $1.4 billion by 2019

Liver cancer market to nearly treble in size to $1.4 billion by 2019

13-11-2013

The value of the hepatocellular cancer (HCC) market is set to grow by a massive 172% and hit $1.4 billion…

BayerEuropeMarkets & MarketingNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalResearchUSA

Geron’s stock price jumps as it reports positive results for myelofibrosis drug

Geron’s stock price jumps as it reports positive results for myelofibrosis drug

08-11-2013

Geron Corp (Nasdaq: GERN) has boosted its share price with the results of a clinical trial into the safety…

FinancialGeron CorpimetelstatNorth AmericaOncologyPharmaceuticalResearchUSA

Novogen teams up with Yale University to investigate ovarian cancer drug delivery

Novogen teams up with Yale University to investigate ovarian cancer drug delivery

06-11-2013

Australian biotech company Novogen (ASX: NRT) has announced a joint venture with Yale University in the…

LicensingNorth AmericaNovogenOncologyPharmaceuticalResearch

Sagent Pharma debuts Carboplatin Injection

Sagent Pharma debuts Carboplatin Injection

04-11-2013

US specialty drugmaker Sagent Pharmaceuticals has announced the launch of Carboplatin Injection, an antineoplastic…

Asia-PacificCarboplatinMarkets & MarketingNorth AmericaOncologyPharmaceuticalProductionSagent Pharmaceuticals

Ariad Pharma “temporarily” suspends only marketed drug Iclusig in USA

Ariad Pharma “temporarily” suspends only marketed drug Iclusig in USA

01-11-2013

US drugmaker Ariad Pharmaceutical says it temporarily suspending the marketing and commercial distribution…

Ariad PharmaceuticalsIclusigMarkets & MarketingNorth AmericaOncologyPharmaceuticalRegulation

Janssen-Cilag submits EMA Marketing Authorization for ibrutinib

Janssen-Cilag submits EMA Marketing Authorization for ibrutinib

31-10-2013

US health care giant Johnson & Johnson subsidiary Janssen-Cilag International has submitted a Marketing…

ibrutinibJanssen-CilagNorth AmericaOncologyPharmaceuticalRegulation

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