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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

Australia's federal court rules that companies can patent genetic material

Australia's federal court rules that companies can patent genetic material

05-09-2014

The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a…

AustraliaBiotechnologyIntellectual propertyLegalPatentsPharmaceutical sciencesRegulation

FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola…

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

Actavis files for generic version of Acorda’s Ampyra

Actavis files for generic version of Acorda’s Ampyra

27-06-2014

US biotech firm Acorda Therapeutics has been advised that Ireland-headquartered generics major Actavis…

Acorda TherapeuticsActavisAmpyraGenericsHealth Medical PharmaMedicinePharmaceutical sciencesPharmacologyRegulationUS Food and Drug AdministrationUSA

US health care providers have concerns on proposed FDA generic drug labeling rules

US health care providers have concerns on proposed FDA generic drug labeling rules

19-06-2014

A survey co-released today by the USA’s Generic Pharmaceutical Association (GPhA) and the National…

GenericsHealth Medical PharmaHealthcareMedicinePharmaceutical sciencesPharmacologyPhysicianRegulationUSA

Prosensa agrees regulatory pathway for drisapersen with FDA

Prosensa agrees regulatory pathway for drisapersen with FDA

04-06-2014

Dutch biotech Prosensa Holding saw its shares fall 5.8% to $9.98 in by close of US trading yesterday,…

BiotechnologyChief executivedrisapersenFood and Drug AdministrationInvestigational productsMuscular dystrophyPharmaceutical sciencesProsensaRare diseasesRegulationUSA

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

Wockhardt target for fresh FDA concerns over US unit

Wockhardt target for fresh FDA concerns over US unit

28-05-2014

Indian drugmaker Wockhardt is facing fresh concerns from the US Food and Drug Administration over processes…

Clinical researchHealth Medical PharmaIndiaManaging directorPharmaceuticalPharmaceutical sciencesProductionRegulationUnited StatesUSAWockhardt

European Commission specifies post-authorization efficacy study guidelines

European Commission specifies post-authorization efficacy study guidelines

11-04-2014

The European Commission has adopted a delegated act specifying the situations where a post-authorization…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalPharmaceutical industryPharmaceutical sciencesPharmacologyRegulationResearch

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