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Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

Orphan drug approvals rise, but high costs pose challenges for patients

Orphan drug approvals rise, but high costs pose challenges for patients

10-07-2014

Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions…

EuropePharmaceuticalPricingRare diseasesRegulationUSA

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

10-07-2014

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention…

Kenneth MandlNeurologicalPharmaceuticalPharmacologyPharmacovigilanceRegulationRitalinUSA

Novartis’ secukinumab significantly more effective in psoriasis than NICE-recommended equivalent

Novartis’ secukinumab significantly more effective in psoriasis than NICE-recommended equivalent

10-07-2014

Data published in the New England Journal of Medicine has shown secukinumab to be more effective at treating…

DermatologicalsetanerceptNovartisPharmaceuticalPsoriasisResearchsecukinumabUSA

MabVax Therapeutics and Telik close merger

MabVax Therapeutics and Telik close merger

09-07-2014

USA-based MabVax Therapeutics, a privately held cancer immunotherapy company, and Telik, a publicly-traded…

MabVax TherapeuticsMergers & AcquisitionsOncologyPharmaceuticalTelikUSA

Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

Varenicline combined with nicotine patch improves smoking cessation rates

Varenicline combined with nicotine patch improves smoking cessation rates

09-07-2014

Combining the smoking cessation medication varenicline with nicotine replacement therapy was more effective…

ChantixNeurologicalNicotinePfizerPharmaceuticalResearchSmoking cessationUSAVarenicline

Fidia completes establishment of operations in North America

Fidia completes establishment of operations in North America

08-07-2014

Fidia Pharma USA, a wholly-owned subsidiary of privately-held Italian drugmaker Fidia Farmaceutici, says…

Anti-Arthritics/RheumaticsFidia FarmaceuticiManagementMarkets & MarketingPharmaceuticalUSA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

08-07-2014

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

Glowing prospects for Novo Nordisk's insulin degludec/liraglutide for type 2 diabetes

Glowing prospects for Novo Nordisk's insulin degludec/liraglutide for type 2 diabetes

07-07-2014

Danish diabetes care giant Novo Nordisk's fixed-dose combination therapy insulin degludec/liraglutide…

DiabetesEuropeIDegLiraMarkets & MarketingNovo NordiskPharmaceuticalUSAXultophy

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

07-07-2014

US-based pharmaceutical company CASI, which develops therapeutics for the treatment of cancer and other…

CASIENMD-2076Hepatocellular carcinomaOncologyPharmaceuticalRegulationUSA

GlobalData says UK fears over antibiotic resistance is

GlobalData says UK fears over antibiotic resistance is "valid conclusion"

04-07-2014

Earlier this week, UK Prime Minister David Cameron revealed the formation of an independent review panel…

Antibiotics and Infectious diseasesEuropePharmaceuticalResearchUSA

FDA approves Spectrum’s Beleodaq for PTCL

FDA approves Spectrum’s Beleodaq for PTCL

04-07-2014

Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum…

BeleodaqbelinostatOncologyPharmaceuticalRegulationSpectrum PharmaceuticalsTopotargetUSA

UCB and Dermira link up for Cimzia in dermatology

UCB and Dermira link up for Cimzia in dermatology

03-07-2014

Belgium’s largest drugmaker UCB and Dermira, a privately held USA-based dermatology company, have entered…

CanadaCimziaDermatologicalsDermiraEuropeLicensingPharmaceuticalResearchUCBUSA

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

JAMA study shows bone marrow transplants can reverse sickle cell disease

03-07-2014

Bone marrow transplants can reverse severe sickle cell disease in adults, according to new data published…

HematologyPharmaceuticalResearchUSA

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Pozen re-files for US approval of PA8140/PA32540

Pozen re-files for US approval of PA8140/PA32540

02-07-2014

US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole)…

AspirinCardio-vascularOmeprazolePA8140/PA32540PharmaceuticalPozenRegulationUSA

US FDA outlines expectations for human drug compounders

US FDA outlines expectations for human drug compounders

02-07-2014

Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug…

PharmaceuticalRegulationUSA

1 to 25 of 370 results

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