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US FDA approves AstraZeneca’s Xigduo XR

US FDA approves AstraZeneca’s Xigduo XR

30-10-2014

The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s once-daily…

AstraZenecaDiabetesPharmaceuticalRegulationUSAXigduo XR

EMA guidance on facilitating global development of biosimilars

EMA guidance on facilitating global development of biosimilars

30-10-2014

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on…

BiosimilarsBiotechnologyEuropeRegulation

Russian Parliament to restrict imports of unregistered drugs

30-10-2014

The Russian National Parliament (State Duma) plans to impose a ban on the imports of unregistered drugs…

PharmaceuticalPoliticsRegulationRussia

US FDA approves first vaccine to prevent serogroup B meningococcal disease

30-10-2014

The US Food and Drug Administration yesterday granted accelerated approval for pharma major Pfizer’s…

PfizerPharmaceuticalRegulationTrumenbaUSAVaccines

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

Polish and European generics groups view opportunities for biosimilars

29-10-2014

The European Biosimilars Group – a sector group of the European Generic medicines Association, together…

BiosimilarsEastern EuropeGenericsMarkets & MarketingPolandPricingRegulation

PBS means Australian patients and government are paying less for products

PBS means Australian patients and government are paying less for products

29-10-2014

Australian patients continue to pay less for medicines due to a notable rise in the number of prescriptions…

AustraliaPharmaceuticalPharmaceutical sciencesPharmacologyRegulation

Russian approval for Norgine/Takeda’s MoviPrep

28-10-2014

Netherlands-headquartered independent drugmaker Norgine says that its partner, Japan’s largest pharma…

Gastro-intestinalsMoviPrepNorginePharmaceuticalRegulationRussiaTakeda Pharmaceutical

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

28-10-2014

Rare and infectious disease specialist Sarepta provided an update on its discussions with the US Food…

CNS DiseaseseteplirsenPharmaceuticalRegulationSarepta TherapeuticsUSA

Merck & Co third-qtr disappoints, as earnings plunge

Merck & Co third-qtr disappoints, as earnings plunge

27-10-2014

US pharma giant Merck & Co (NYSE: MRK) posted third-quarter 2014 financial results today, showing that…

FinancialKeytrudaMerck & CoOncologyPharmaceuticalRegulationUSA

EuropaBio’s new White Paper 'Realising the Potential of Personalized Medicine in Europe'

27-10-2014

Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations…

BiotechnologyEuropeRegulationResearch

Hikma shares slide as FDA issues warning letter over its Portugal injectables plant

Hikma shares slide as FDA issues warning letter over its Portugal injectables plant

27-10-2014

Jordanian drugmaker Hikma has seen its shares fall as a result of a warning from the US Food and Drug…

Hikma PharmaceuticalsHospiraPharmaceuticalPortugalRegulation

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

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

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

AstraZeneca’s Lynparza backed for approval by EMA committee

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

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

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

Discussion launched about the future of biosimilars in Italy

Discussion launched about the future of biosimilars in Italy

23-10-2014

Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines…

BiosimilarBiosimilarsBiotechnologyItalyRegulation

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

UK’s NICE backs another use for Bayer’s Xarelto

UK’s NICE backs another use for Bayer’s Xarelto

23-10-2014

In draft guidance published today for consultation, the UK’s health costs watchdog the National Institute…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

FDA advisory backs expanded use of Vertex’ CF drug

22-10-2014

There was good news for US biotech firm Vertex Pharmaceuticals yesterday, as a US Food and Drug Administration…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

1 to 25 of 2649 results

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