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FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

20-12-2014

The US Food and Drug Administration on Friday confirmed the much anticipated approval of US pharma company…

AbbVieAnti-viralsPharmaceuticalRegulationUSAViekira Pak

FDA approves new antibacterial drug Zerbaxa

20-12-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’Zerbaxa (ceftolozane/tazobactam)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsMerck & CoPharmaceuticalRegulationUSAZerbaxa

Cuba a huge opportunity for life sciences, says Abivax

Cuba a huge opportunity for life sciences, says Abivax

19-12-2014

Paris-based antiviral specialist Abivax has spoken in praise of the decision between the USA and Cuba…

ABIVAXABIVAXCubaPharmaceuticalUnited States

Pfizer touts strong Ph III results for Lyrica CR for postherpetic neuralgia

Pfizer touts strong Ph III results for Lyrica CR for postherpetic neuralgia

19-12-2014

US pharma giant Pfizer has released top-line results from a double-blind Phase III study evaluating pregabalin…

LyricaNeurologicalPfizerPharmaceuticalPregabalinResearchUSA

PhRMA releases new report on challenges to developing new hepatitis C treatments

PhRMA releases new report on challenges to developing new hepatitis C treatments

19-12-2014

The Pharmaceutical Research and Manufacturers of America released a new report examining the scientific…

Manufacturers of AmericaPharmaceuticalPhRMAResearchRespiratory and Pulmonary

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

19-12-2014

Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine…

ADI-PEG 20OncologyPharmaceuticalPolaris GroupRegulation

Cardinal Health and Bayer sign 15-year contract manufacturing agreement for Xofigo

Cardinal Health and Bayer sign 15-year contract manufacturing agreement for Xofigo

19-12-2014

Cardinal Health and German drug major Bayer have signed a 15-year agreement for the contract manufacturing…

BayerCardinal HealthLicensingOncologyPharmaceuticalProductionUSAXofigo

CSL Behring files BLA for hemophilia B agent

CSL Behring files BLA for hemophilia B agent

18-12-2014

USA-based CSL Behring, a unit of Australia’s CSL Ltd, has submitted a biologics license application…

CSL BehringCSL LimitedHematologyPharmaceuticalRegulationUSA

GSK shingles vaccine candidate meets Ph III primary endpoint

GSK shingles vaccine candidate meets Ph III primary endpoint

18-12-2014

UK pharma major GlaxoSmithKline today released pivotal Phase III study data to assess the efficacy of…

AgenusAnti-viralsGlaxoSmithKlineHZ/suPharmaceuticalResearchVaccines

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

18-12-2014

US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration…

Cardio-vascularPharmaceuticalPozenRegulationUSAYosprala 325/40Yosprala 81/40

China's Ebola vaccine enters clinical trials

China's Ebola vaccine enters clinical trials

18-12-2014

An Ebola vaccine developed by a military-tied research institute has been approved to enter the human…

Anti-viralsChinaPharmaceuticalResearchVaccines

Verona Pharma appoints Kenneth Newman to newly-created chief medical officer position

Verona Pharma appoints Kenneth Newman to newly-created chief medical officer position

18-12-2014

Respiratory disease specialist Verona Pharma has appointed Kenneth Newman to the newly-created chief…

BoardroomPharmaceuticalRespiratory and PulmonaryUKVerona Pharma

European Commission grants marketing authorization to AstraZeneca's Lynparza

European Commission grants marketing authorization to AstraZeneca's Lynparza

18-12-2014

Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission…

AstraZenecaLynparzaOncologyPharmaceuticalRegulation

FDA approves Alcon’s Xtoro to treat swimmer’s ear

FDA approves Alcon’s Xtoro to treat swimmer’s ear

18-12-2014

The US Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used…

Acute otitis externaAlcon LaboratoriesAntibiotics and Infectious diseasesHealthNovartisPharmaceuticalRegulationUSAXtoro

Insulin therapeutics specialist Nutrinia completes $12 million financing round

Insulin therapeutics specialist Nutrinia completes $12 million financing round

18-12-2014

Nutrinia, a developer of oral insulin therapies to treat rare gastrointestinal disorders in babies, has…

Business FinanceEndocrine systemGastro-intestinalsNutriniaPharmaceutical

Eisai's Halaven now available in Russia for advanced breast cancer

Eisai's Halaven now available in Russia for advanced breast cancer

18-12-2014

Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia.

EisaiHalavenOncologyPharmaceuticalRegulationRussia

Lundbeck to stop further development of desmoteplase

Lundbeck to stop further development of desmoteplase

18-12-2014

Following evaluation of disappointing clinical results, Danish CNS specialists Lundbeck said late yesterday…

Cardio-vasculardesmoteplaseFinancialLundbeckNeurologicalPharmaceuticalResearch

Auspex leaps on positive results from Phase III trial of SD-809 in Huntington's chorea

Auspex leaps on positive results from Phase III trial of SD-809 in Huntington's chorea

17-12-2014

Movement disorder biopharma specialist Auspex Pharmaceuticals announced positive top-line data from its…

Auspex PharmaceuticalsNeurologicalPharmaceuticalResearchSD-809USA

Strong top-line results for Poxel’s antidiabetic agent imeglimin

Strong top-line results for Poxel’s antidiabetic agent imeglimin

17-12-2014

France-based drug developer Poxel says that imeglimin, a novel compound in development to treat type…

DiabetesFranceHealthimegliminMerck SeronoPharmaceuticalPoxelResearch

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