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NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

Celgene’s Imnovid now reimbursed in Sweden, Spain and Switzerland

Celgene’s Imnovid now reimbursed in Sweden, Spain and Switzerland

11-07-2014

US biotech firm Celgene’s Imnovid (pomalidomide), called Pomalyst in the USA, is now approved for reimbursement…

BiotechnologyCelgeneFinancialHealthcareImnovidOncologyPomalystSpainSweden

inVentiv and ACRES partner to create a global research platform for clinical trials

inVentiv and ACRES partner to create a global research platform for clinical trials

11-07-2014

Two bodies are partnering to fast-track the development of a global system to support responsible conduct…

BiotechnologyClinical researchDrug developmentGlobalGreg KoskiinVentive HealthPharmaceuticalResearch

Oxford BioTherapeutics appoints Eugen Leo as head of clinical development

Oxford BioTherapeutics appoints Eugen Leo as head of clinical development

11-07-2014

UK-based biotech company Oxford BioTherapeutics, focusing on antibody-drug conjugates in the treatment…

BiotechnologyBoardroomOxford BioTherapeuticsUK

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

Beike receives approval from Chinese FDA for umbilical stem cells in lupus

Beike receives approval from Chinese FDA for umbilical stem cells in lupus

10-07-2014

China-based stem cell research company Beike Biotechnology has been accepted into the approval process…

beikeBeike BiotechnologyBiotechnologyChinaGuangdong Food and Drug AdministrationImmunologicalsRegulationStem cells

Northeast England gets $34 million investment to fund biotechnology facility

Northeast England gets $34 million investment to fund biotechnology facility

10-07-2014

The Centre for Process Innovation has announced investment of £20 million ($34 million) to fund a ‘Biologics…

BiotechnologyCentre for Process InnovationCounty DurhamCPIHealthcareNational Biologics Manufacturing CentreUK

Regado Biosciences announces FDA’s clinical hold of Ph III trial

Regado Biosciences announces FDA’s clinical hold of Ph III trial

10-07-2014

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences…

Acute coronary syndromeBiotechnologybivalirudinCardio-vascularMedicineRegadoRegulationUSA

Baxter buys AesRx, gaining rights to investigational SCD drug

Baxter buys AesRx, gaining rights to investigational SCD drug

10-07-2014

US drugmaker Baxter International said yesterday that it has acquired AesRx, a private US biopharmaceutical…

Aes-103AesRxBaxter InternationalBiotechnologyHematologyMergers & AcquisitionsRare diseasesUSA

Celgene’s Otezla misses endpoint in Ph III ankylosing spondylitis study

Celgene’s Otezla misses endpoint in Ph III ankylosing spondylitis study

09-07-2014

Shares of US biotech firm Celgene fell 3.5% in premarket trade, but were up 1.2% $86.75 by mid-morning…

Anti-Arthritics/RheumaticsBiotechnologyCelgeneOtezlaResearchUSA

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

09-07-2014

The US Food and Drug Administration has approved privately-held US biotech firm Protein Sciences’ strain…

BiotechnologyFlublokInfluenzaProtein Sciences CorpRegulationUSAVaccines

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

SMC guidance on AstraZeneca’s diabetes drug and Roche’s MabThera

SMC guidance on AstraZeneca’s diabetes drug and Roche’s MabThera

08-07-2014

The Scottish Medicines Consortium (SMC) has issued guidance on Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaBiotechnologydapagliflozinDiabetesMabTheraOncologyRocheUK

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

08-07-2014

Australian health care regulator the Therapeutic Goods Administration (TGA) has approved the use of US…

Anti-viralsAustraliaBiotechnologyGilead SciencesRegulationSovaldi

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

07-07-2014

This month, the government of Brazil’s State of Rio de Janeiro, the Brazilian Development Bank (BNDES),…

BionovisBiosimilarsBiotechnologyBrazilFinancialFiocruzProductionResearch

BIND Thera and Amgen end their Accurin collaboration

BIND Thera and Amgen end their Accurin collaboration

03-07-2014

US clinical stage drug developer BIND Therapeutics saw its shares plunge 15.8% to $10.84 in after-hours…

AccurinsAmgenBIND TherapeuticsBiotechnologyLicensingOncology

Merck Serono to establish production of Rebif in Russia

Merck Serono to establish production of Rebif in Russia

03-07-2014

Merck Serono, the biotech unit of Germany’s Merck KGaA, plans to establish production of its multiple…

BiotechnologyMerck KGaAMerck SeronoNeurologicalPharmstandardProductionRebifRussia

Bio-Techne to acquire Novus Biologicals

03-07-2014

USA-based Techne Corp (d/b/a Bio-Techne) has acquired Novus Biologicals for $60 million in cash. The…

Bio-TechneBiotechnologyMergers & AcquisitionsNovus Biologicals

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

NicOx to acquire Aciex Therapeutics

02-07-2014

Ophthalmology-focused French biotech firm NicOx has entered into an agreement to acquire all of the outstanding…

Aciex TherapeuticsBiotechnologyInflammatory diseasesMergers & AcquisitionsNicOxOphthalmics

Roche to acquire Seragon in deal that could reach over $1.7 billion

Roche to acquire Seragon in deal that could reach over $1.7 billion

02-07-2014

Swiss drug major Roche says its USA-based biotech subsidiary Genentech has entered into a definitive…

BiotechnologyGenentechMergers & AcquisitionsOncologyRocheSeragon Pharmaceuticals

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Will innovations in biomarkers lead to a paradigm shift in drug discovery?

01-07-2014

With the efficacy for most drugs targeting severe therapeutic indications ranging from a meagre 25% to…

BiotechnologyEuropeMarkets & MarketingResearch

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