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FDA approves Spectrum’s Beleodaq for PTCL

FDA approves Spectrum’s Beleodaq for PTCL

04-07-2014

Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum…

BeleodaqbelinostatOncologyPharmaceuticalRegulationSpectrum PharmaceuticalsTopotargetUSA

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

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

UCB and Dermira link up for Cimzia in dermatology

UCB and Dermira link up for Cimzia in dermatology

03-07-2014

Belgium’s largest drugmaker UCB and Dermira, a privately held USA-based dermatology company, have entered…

CanadaCimziaDermatologicalsDermiraEuropeLicensingPharmaceuticalResearchUCBUSA

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

South Africa trade group intensifies efforts on generics access

03-07-2014

South Africa’s National Association of Pharmaceutical Manufacturer’s has appointed its new Executive…

GenericsHealthcarePoliticsPricingSouth Africa

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

Opportunities ripe for Pharma in Ghana and Nigeria

03-07-2014

Strong business opportunities exist for big pharmaceutical and generic pharmaceutical companies in Ghana…

HealthcareMarkets & MarketingPharmaceutical

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

Isis Pharma earns $1 million GSK milestone on hepatitis B virus program

Isis Pharma earns $1 million GSK milestone on hepatitis B virus program

03-07-2014

USA-based Isis Pharmaceuticals has earned yet another $1 million payment from UK pharma giant GlaxoSmithKline,…

Anti-viralsFinancialGlaxoSmithKlineIsis PharmaceuticalsPharmaceuticalResearch

JAMA study shows bone marrow transplants can reverse sickle cell disease

03-07-2014

Bone marrow transplants can reverse severe sickle cell disease in adults, according to new data published…

HematologyPharmaceuticalResearchUSA

New OECD data shows Australia lagging in investing in medicines

New OECD data shows Australia lagging in investing in medicines

03-07-2014

Data newly released by the Organization for Economic Cooperation and Development (OECD) reveals that…

AustraliaFinancialHealthcarePharmaceutical

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Salix leaps on positive Ph III results with Xifaxan in IBS-D

Salix leaps on positive Ph III results with Xifaxan in IBS-D

02-07-2014

US drugmaker Salix Pharmaceuticals’ saw its shares leap as much as 13% after the company released new…

Gastro-intestinalsPharmaceuticalResearchrifaximinSalix PharmaceuticalsXifaxan

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

Novartis takes action as former employee is arrested in Japan

Novartis takes action as former employee is arrested in Japan

02-07-2014

Swiss drug major Novartis (NOVN: VX) said yesterday that Novartis Pharma K.K. (NPKK) understands that…

JapanLegalNovartisPharmaceutical

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

Pozen re-files for US approval of PA8140/PA32540

Pozen re-files for US approval of PA8140/PA32540

02-07-2014

US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole)…

AspirinCardio-vascularOmeprazolePA8140/PA32540PharmaceuticalPozenRegulationUSA

US FDA outlines expectations for human drug compounders

US FDA outlines expectations for human drug compounders

02-07-2014

Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug…

PharmaceuticalRegulationUSA

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