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FDA approves Baxter’s new treatment for rare form of hemophilia

25-10-2014

The US Food and Drug Administration on Friday approved Obizur (antihemophilic Factor [recombinant), porcine…

Baxter InternationalHematologyObizurPharmaceuticalRare diseasesUSA

Novo Nordisk subpoenaed by US Attorney

25-10-2014

Danish diabetes care giant Novo Nordis on Friday revealed it had been served with a subpoena by the office…

DenmarkDiabetesLegalNovo NordiskPharmaceuticalProductionUSA

FDA requests CMC data on Lundbeck’s Carbella application

25-10-2014

Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the…

CarbamazepineCarbellaLigand PharmaceuticalsLundbeckNeurologicalPharmaceuticalRegulationUSA

Scenesse recommended for rare disease by EMA/CHMP

24-10-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Clinuvel PharmaceuticalsEuropePharmaceuticalRare diseasesRegulationScenesse

EMA calls for strengthened warnings for Iclusig

24-10-2014

The European Medicines Agency has concluded its review of the benefits and risks of Iclusig (ponatinib),…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

Shire posts sharp rises in sales and earnings for third-qtr

24-10-2014

Ireland-headquartered Shire has delivered a strong set of financials for the third-quarter of 2014, validating…

AbbVieFinancialPharmaceuticalShire

AstraZeneca’s Lynparza backed for approval by EMA committee

24-10-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

AstraZenecaEuropeLynparzaolaparibOncologyPharmaceuticalRegulation

EMA completes review of polymyxins and issues updated guidance

EMA completes review of polymyxins and issues updated guidance

24-10-2014

The European Medicines Agency has completed its review of polymyxin-based medicines and issued its recommendations…

Antibiotics and Infectious diseasesColistimethateEuropePharmaceuticalRegulation

VIDEO: Chief executive Sir Andrew Witty discusses GSK's results

VIDEO: Chief executive Sir Andrew Witty discusses GSK's results

24-10-2014

Chief executive of UK pharma giant GlaxoSmithKline Sir Andrew Witty has commented on the company's third…

FinancialGlaxoSmithKlinePharmaceuticalPharmaceutical industryUK

Australian government to undertake review of medicines and medical devices regulation

Australian government to undertake review of medicines and medical devices regulation

24-10-2014

The Australian government is to carry out a review of the regulation of medicines and medical devices.

AustraliaMedicineMedicines AustraliaPharmaceuticalRegulation

Singapore reports sharp downturn in biomedical manufacturing for September

24-10-2014

On a year-on-year basis, Singapore’s manufacturing output contracted 1.2% in September 2014, mainly…

PharmaceuticalSingapore

Experts' comments on GSK floating its HIV business

24-10-2014

The announcement this week by UK pharma giant GlaxoSmithKline that it is mulling a possible initial public…

FinancialGlaxoSmithKlinePharmaceuticalViiV Healthcare

Vaxart accelerates development of Ebola tablet vaccine

24-10-2014

Privately-held US vaccine developer Vaxart says it is accelerating its Ebola tablet vaccine program.…

Anti-viralsPharmaceuticalResearchVaccinesVaxart

Genmab gets latest milestone in daratumumab Janssen collaboration

Genmab gets latest milestone in daratumumab Janssen collaboration

24-10-2014

Danish biotech company Genmab has reached the fourth milestone in its daratumumab collaboration with…

daratumumabDenmarkGenmabJanssenOncologyPharmaceuticalResearch

Acute pain market to grow less than 0.5% between 2013 and 2023, says new research

Acute pain market to grow less than 0.5% between 2013 and 2023, says new research

24-10-2014

The acute pain market will experience only minimal growth between 2013 and 2023, according to biopharma…

AnalgesiaCelebrexDecision Resources GroupMarkets & MarketingPharmaceutical

Stallergenes furthers global expansion and opens affiliate in Ontario, Canada

Stallergenes furthers global expansion and opens affiliate in Ontario, Canada

24-10-2014

Stallergenes, a France-based global healthcare company specialized in diagnosis and treatment of allergies,…

CanadaMarkets & MarketingOralairPharmaceuticalRespiratory and PulmonaryStallergenes

Takeda gains exclusive rights to Amitiza beyond US and Canada

Takeda gains exclusive rights to Amitiza beyond US and Canada

23-10-2014

US biopharma company Sucampo Pharmaceuticals saw its shares rise 5.6% to $8.46 in morning trading, after…

AmitizaGastro-intestinalsGlobalLicensingPharmaceuticalSucampoTakeda Pharmaceutical

Lilly expands collaboration with Zymeworks

Lilly expands collaboration with Zymeworks

23-10-2014

US pharma major Eli Lilly and privately-held Canadian biotech firm Zymeworks have expanded their existing…

CanadaEli LillyLicensingOncologyPharmaceuticalResearchUSAZymeworks

Ferring Pharma’s Cortiment gains EU approval

Ferring Pharma’s Cortiment gains EU approval

23-10-2014

Privately-held Switzerland-headquartered Ferring Pharmaceuticals says its Cortiment (budesonide) treatment…

CortimentCosmo PharmaceuticalsEuropeFerring PharmaceuticalsGastro-intestinalsPentasaPharmaceuticalRegulation

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

Cost of Australian PBS rises below rate of inflation for 2013-2014

Cost of Australian PBS rises below rate of inflation for 2013-2014

23-10-2014

The Australian Department of Health has confirmed that growth of the Pharmaceutical Benefits Scheme cost…

AustraliaMedicines AustraliaPharmaceuticalPharmaceuticals policyRegulation

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