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Alkermes files NDA for aripiprazole lauroxil in schizophrenia

Alkermes files NDA for aripiprazole lauroxil in schizophrenia

26-08-2014

Ireland-headquartered biotech firm Alkermes has submitted a New Drug Application to the US Food and Drug…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyNeurologicalRegulationUSA

ViaCyte gets $20 million in deal with Janssen

ViaCyte gets $20 million in deal with Janssen

22-08-2014

Privately held US regenerative medicine company ViaCyte has entered into a rights agreement with Janssen…

BiotechnologyDiabetesEndocrine systemFinancialJanssenJohnson & JohnsonLicensingUSAVC-01ViaCyte

Genzyme’s Cerdelga gets FDA approval for Gaucher disease

Genzyme’s Cerdelga gets FDA approval for Gaucher disease

20-08-2014

The US Food and Drug Administration late yesterday approved Cerdelga (eliglustat) for the long-term treatment…

ActelionBiotechnologyCerdelgaCerezymeGenzymeRare diseasesRegulationSanofiUSAZavesca

Further positive Ph III results for Amgen’s AMG 416 in secondary hyperparathyroidism

Further positive Ph III results for Amgen’s AMG 416 in secondary hyperparathyroidism

19-08-2014

USA-based Amgen has released positive data from a second placebo-controlled Phase III study evaluating…

AMG 416AmgenBiotechnologyClinical researchHemodialysisNephrology and HepatologyResearchUSA

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

17-08-2014

The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy…

Biogen IdecBiotechnologyNeurologicalPlegridyRegulationUSA

Gilead gets favorable ruling in Roche arbitration

Gilead gets favorable ruling in Roche arbitration

17-08-2014

US biotech major Gilead Sciences said on Friday in a Security and Exchange Commission filing that an…

Anti-viralsArbitrationBiotechnologyBusiness FinanceBusiness FinanceGilead SciencesLegalPatentsPharmassetRocheSovaldiUSA

Ligand signs Captisol license deal with Avion Pharmaceuticals

Ligand signs Captisol license deal with Avion Pharmaceuticals

15-08-2014

Ligand Pharmaceuticals has signed a commercial license agreement with fellow USA-based Avion Pharmaceuticals,…

Avion PharmaceuticalsBiotechnologyBusiness FinanceCaptisolLicensingLigand PharmaceuticalsUSA

Amgen’s Kyprolis failed to meet primary endpoint in multiple myeloma trial

Amgen’s Kyprolis failed to meet primary endpoint in multiple myeloma trial

14-08-2014

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

Advanced refractory multiple myelomaAmgenBiotechnologyKyprolisOncologyOnyx PharmaceuticalsResearchUSA

TNI BioTech and Hubei Qianjiang link up on cancer drug development

TNI BioTech and Hubei Qianjiang link up on cancer drug development

13-08-2014

US biotech firm TNI BioTech has signed a supplemental agreement with China’s Hubei Qianjiang Pharmaceutical…

BiotechnologyBusiness FinanceChinaHubeiLicensingOncologyQianjiang PharmaceuticalResearchTNI BioTechUSA

Dendreon shares fall as company warns of worry over debt repayment

Dendreon shares fall as company warns of worry over debt repayment

13-08-2014

Shares of US biotech firm Dendreon have fallen after it warned shareholders about debt problems.

BiotechnologyBusiness FinanceCancer vaccinesDendreonFinancialProvengeSipuleucel-TUSA

Oncothyreon acquires Alpine Biosciences

Oncothyreon acquires Alpine Biosciences

12-08-2014

US biotech firm Oncothyreon says that it has acquired Alpine Biosciences, of Seattle, Washington, a privately…

Alpine BiosciencesBiotechnologyBusiness FinanceImmunotherapyMedicineMergers & AcquisitionsOncologyOncothyreonRare diseasesUSA

Oxis looking to enter cannabis biotech sector

Oxis looking to enter cannabis biotech sector

11-08-2014

USA-based Oxis International, currently working on products around the effects of oxidative stress, is…

BiotechnologyEntheogensMedical cannabisOxisProductionUSA

FDA issues new biosimilars guidance on exclusivity

FDA issues new biosimilars guidance on exclusivity

11-08-2014

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…

BiosimilarsBiotechnologyFinancialRegulationUSA

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