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Orphan status in Europe for Alexion’s Soliris in myasthenia gravis

01-08-2014

The European Commission has granted orphan drug designation (ODD) to US drugmaker Alexion Pharmaceuticals’…

Alexion PharmaceuticalsBiotechnologyEuropeRare diseasesRegulationSoliris

UK aims to become world number one in DNA testing with new investment

UK aims to become world number one in DNA testing with new investment

01-08-2014

David Cameron, the UK Prime Minister, has announced a package of investment worth more than £300 million…

BiotechnologyDavid CameronGeneticsIlluminaMedical Research CouncilResearchUK

FDA advisory panel backs Baxter’s HyQvia for primary immunodeficiency

FDA advisory panel backs Baxter’s HyQvia for primary immunodeficiency

01-08-2014

The Blood Products Advisory Committee of the US Food and Drug Administration has voted 15-1 that HyQvia…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUS Food and Drug AdministrationUSA

USA’s 340B Drug Discount Program “needs more oversight,” says BIO

USA’s 340B Drug Discount Program “needs more oversight,” says BIO

01-08-2014

The US Biotechnology Industry Organization’s (BIO) Laurel Todd shared concerns that the 340B program…

BiotechnologyFinancialHealthcareRegulationUSA

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

Regeneron’s Eylea gains FDA approval for DME

Regeneron’s Eylea gains FDA approval for DME

30-07-2014

The Food and Drug Administration has approved US biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneronRegulationUSA

Cellectis sells Swedish subsidiary to Japan’s Takara Bio

30-07-2014

France-based genome engineering specialist Cellectis says it has sold its Swedish subsidiary Cellectis…

BiotechnologyBusiness FinanceCellectisCellectis ABFranceMergers & AcquisitionsTakara Bio

Amgen’s 2nd-qtr beats expectations, but firm slashes workforce

Amgen’s 2nd-qtr beats expectations, but firm slashes workforce

30-07-2014

Amgen, the largest global independent biotech firm, reported a 23% leap in second-quarter 2014 profit…

AmgenBiotechnologyFinancialManagement

Targacept to drop TC-5214 development in overactive bladder

Targacept to drop TC-5214 development in overactive bladder

29-07-2014

US-based clinical-stage biopharma company Targacept plans to halt development of TC-5214 as a treatment…

AstraZenecaBiotechnologyGenito-urinaryResearchTargaceptTC-5214USA

Antiviral gel in condoms to kill HIV approved in Australia

Antiviral gel in condoms to kill HIV approved in Australia

28-07-2014

Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity…

AnsellAnti-viralsAntibiotics and Infectious diseasesAustraliaBiotechnologyRegulationStarpharmaVivaGel

EMA’s CHMP backs approval of two new treatment options for rare cancers

EMA’s CHMP backs approval of two new treatment options for rare cancers

26-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting,…

BiotechnologyEuropeFinancialGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonOncologyRegulationZydelig

Taiho Pharma and Sumitomo Dainippon both invest in Remiges BioPharma Fund

25-07-2014

Japanese oncology-focussed drugmaker Taiho Pharmaceutical has said that it will be investing $30 million…

BiotechnologyDainippon Sumitomo PharmaFinancialJapanOncologyRemiges BioPharma FundTaiho Pharmaceutical

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

Celgene posts strong sales and earnings for 2nd-qtr

24-07-2014

US biotech firm Celgene reported net product sales of $1,845 million for the second quarter of 2014,…

BiotechnologyCelgene Corp.Financial

Gilead beats forecasts as Sovaldi sales soar

Gilead beats forecasts as Sovaldi sales soar

24-07-2014

US anti-virals specialist biotech firm Gilead Sciences has reported surging second-quarter 2014 sales…

Anti-viralsBiotechnologyBusiness FinanceBusiness FinanceChemistryFinancialFixed dose combinationGilead SciencesSovaldiTenofovir

US FDA approves Gilead’s Zydelig for three types of blood cancers

US FDA approves Gilead’s Zydelig for three types of blood cancers

24-07-2014

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US…

BiotechnologyGilead SciencesidelalisibOncologyRegulationUSAZydelig

Biogen Idec’s 2nd-qtr 40% revenues growth beats forecasts

Biogen Idec’s 2nd-qtr 40% revenues growth beats forecasts

23-07-2014

Shares of US biotech firm Biogen Idec jumped 7.35% to $326 in pre-market trading today, as the company…

AlprolixBiogen IdecBiotechnologyElocateFinancialImmunologyPharmacologyTecfideraUSA

Shire in strategic collaboration with ArmaGen for Hunter syndrome

Shire in strategic collaboration with ArmaGen for Hunter syndrome

23-07-2014

Ireland-headquartered drugmaker Shire has entered into an agreement with US privately held biotech company…

AGT-182ArmagenBiotechnologyCNS DiseasesHunter syndromeIrelandLicensingShireUSA

Puma Biotech rockets on new neratinib data; amends deal with Pfizer

Puma Biotech rockets on new neratinib data; amends deal with Pfizer

23-07-2014

US development-stage company Puma Biotechnology saw its share more than triple to $190 in after-hours…

BiotechnologyLicensingneratinibOncologyPB272PfizerPuma BiotechResearchTrastuzumabUSA

Celgene's cancer drug Istodax could re-activate dormant HIV and allow it to be detected

Celgene's cancer drug Istodax could re-activate dormant HIV and allow it to be detected

23-07-2014

An anti-cancer drug developed by US biotech company Celgene Corp can re-activate dormant HIV which allows…

Aarhus UniversityAnti-viralsBiotechnologyCelgene Corp.DenmarkHIVHIV/AIDSIsodaxResearchromidepsin

1 to 25 of 2258 results

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