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Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

Proposed new bill would create new patent term extension for certain biologics patents in USA

Proposed new bill would create new patent term extension for certain biologics patents in USA

26-03-2014

Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property…

BiotechnologyLegalNorth AmericaPatentsPoliticsUSA

US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi

24-03-2014

Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

Celgene’s Otezla is first oral therapy OKed by FDA for adults with active psoriatic arthritis

23-03-2014

The US Food and Drug Administration on Friday approved US biotech firm Celgene’s Otezla (apremilast),…

Anti-Arthritics/RheumaticsapremilastBiotechnologyCelgeneNorth AmericaOtezlaRegulationUSA

US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

BioAlliance Pharma licenses Sitavig to Innocutis in North America

19-03-2014

French drug developer BioAlliance Pharma has executed a licensing accord with the USA’s Innocutis Holdings…

Anti-viralsBioAlliance PharmaBiotechnologyInnocutis HoldingsLicensingNorth AmericaSitavig

FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

US Court upholds damages award in Actelion/Asahi litigation

14-03-2014

Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for…

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Amarin files suit against AstraZeneca over Epanova

Amarin files suit against AstraZeneca over Epanova

05-03-2014

US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint…

AmarinAstraZenecaBiotechnologyCardio-vascularEpanovaLegalNorth AmericaOmthera PharmaceuticalsPatentsUSAVascepa

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

04-03-2014

Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Amarin calls on FDA to extend Vascepa exclusivity by five years

28-02-2014

US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaUSAVascepa

FDA backs Kalydeco for eight additional mutations that cause cystic fibrosis

22-02-2014

The US Food and Drug Administration approved biotech firm Vertex Pharmaceuticals’ supplemental New…

BiotechnologyKalydecoNorth AmericaRare diseasesRegulationUSAVertex

AHF claims victory over FDA on Gilead’s PrEP

19-02-2014

The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

FDA approves Northera for neurogenic orthostatic hypotension

FDA approves Northera for neurogenic orthostatic hypotension

19-02-2014

Shares of US biotech firm Chelsea Therapeutics soared 38% to $6.75 in after-hours trading yesterday,…

BiotechnologyChelsea TherapeuticsDainippon Sumitomo PharmaNorth AmericaNortheraRare diseasesRegulationUSA

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Whistleblower law suit against Celgene unsealed

Whistleblower law suit against Celgene unsealed

07-02-2014

A US federal court yesterday unsealed a whistleblower/false claims law suit brought against US biotech…

BiotechnologyCelgeneLegalMarkets & MarketingNorth AmericaOncologyRevlimidThalomidUSA

Call for Medicaid formularies to block Gilead’s $1,000 per pill hepatitis drug

Call for Medicaid formularies to block Gilead’s $1,000 per pill hepatitis drug

30-01-2014

In a series of letters to be sent to state Medicaid directors starting this week, Michael Weinstein,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPricingSovaldiUSA

NW Bio to expand manufacturing of DCVax products

27-01-2014

US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

1 to 25 of 437 results

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