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Access to many more medicines in Australia, as PBS list extended

28-10-2012

More than 110,000 Australians will benefit from better access to affordable medicines following the Australian…

Asia-PacificBayerEyleaMyforticNovartisPharmaceuticalPricingRegulation

UK's NICE reverses earlier negative decision on Pharmaxis' CF treatment Bronchitol

28-10-2012

Australia's Pharmaxis (ASX: PXS) says that the UK drugs watchdog the National Institute for Health and…

BronchitolEuropePharmaceuticalPharmaxisRare diseasesRegulationRespiratory and Pulmonary

Novo Nordisk says US FDA advisory panel to focus on degludec cardiovascular safety

26-10-2012

Denmark-based insulin giant Novo Nordisk (NOV: N) late yesterday announced that the US Food and Drug…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

Russian government to stimulate conduct of clinical trials by foreign pharma producers

25-10-2012

The Russian government plans to actively attract the world's largest pharmaceutical manufacturers to…

BiotechnologyEuropePharmaceuticalRegulationResearch

Conditional European approval for Pfizer's Xalkori

25-10-2012

The European Commission yesterday gave conditional marketing authorization for global drugs behemoth…

EuropeOncologyPfizerPharmaceuticalRegulationXalkori

UK govt sets out proposals to cut risks for pharmaceutical research

24-10-2012

A new consultation launched yesterday by the Department for Business, Innovation & Skills (BIS) sets…

BiotechnologyEuropePatentsPharmaceuticalRegulationResearch

Amgen's Xgeva gets NICE backing for bone metastasis

24-10-2012

New guidance published today (October 24) by the UK's drugs watchdog the National Institute for Health…

AmgenBiotechnologyEuropeOncologyPricingRegulationXgeva

EMA to investigate Roche's alleged non-compliance with pharmacovigilance

23-10-2012

The European Medicines Agency has started an infringement procedure against Swiss drug major Roche (ROG;…

EuropePharmaceuticalRegulationRoche

Actelion files for US approval of Opsumit for PAH

23-10-2012

Europe's largest biotech company Actelion (SIX: ATLN) said yesterday that it has submitted a New Drug…

ActelionBiotechnologymacitentanNorth AmericaOpsumitRegulationResearchRespiratory and Pulmonary

Orexigen gets FDA dispute response supportive of faster path to Contrave review

22-10-2012

The USA's Orexigen Therapeutics (Nasdaq: OREX) saw its shares jump 9.3% in early trading yesterday, after…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearch

EMA panel backing for Novo Nordisk's Tresiba and Ryzodeg: Japanese review

22-10-2012

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday announced…

Asia-PacificDegludecDiabetesEuropeNovo NordiskPharmaceuticalRegulationRyzodegTresiba

Taiwan beats Japan and South Korea to PIC/S membership

19-10-2012

Taiwan's Food and Drug Administration of the Department of Health has finally succeeded in knocking the…

Asia-PacificGenericsPharmaceuticalProductionRegulation

Vivus gets formal "No" from EMA panel on obesity drug

19-10-2012

US drugmaker Vivus (Nasdaq: VVUS) revealed yesterday that is has received the formal opinion from the…

EuropeMetabolicsPharmaceuticalQsivaRegulationVivus

FDA clears new use for Eli Lilly's Alimta

19-10-2012

US drug major Eli Lilly (NYSE: LLY) says that patients may receive Alimta (pemetrexed for injection)…

AlimtaEli LillyNorth AmericaOncologyPharmaceuticalRegulation

US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine

18-10-2012

Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics…

Anti-viralsNorth AmericaPharmaceuticalRegulationSanofiSanofi PasteurVaccines

AB Science files pancreatic cancer candidate masitinib with EMA

17-10-2012

France-based AB Science SA (NYSE Euronext - FR0010557264 - AB) has confirmed the filing of a Marketing…

AB ScienceEuropemasitinibOncologyPharmaceuticalRegulation

Many UK patients still not receiving cost-effective NICE approved medicines

17-10-2012

A new report published yesterday by the UK's Health and Social Care Information Centre shows that NICE…

EuropeGenericsMarkets & MarketingPharmaceuticalRegulation

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