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FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

17-02-2015

In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks the…

FDAPharmaceuticalPharmacologyRegulationUSA

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

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

06-10-2014

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar…

BiosimilarsBiotechnologyDenmarkPharmacologyRegulation

Innovative and orphan drugs to become more accessible in Russia

Innovative and orphan drugs to become more accessible in Russia

30-09-2014

The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian…

PharmaceuticalPharmacologyRegulationResearchRussia

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

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

PharmaceuticalPharmacologyRegulationResearchUSA

Medicines New Zealand updates its code of practice to cover social media

Medicines New Zealand updates its code of practice to cover social media

13-08-2014

New Zealand's pharmaceutical industry association, Medicines New Zealand, has updated its Code of Practice…

New ZealandPharmaceuticalPharmaceuticals policyPharmacologyRegulation

US federal drug discount program “faces challenges as it expands”

US federal drug discount program “faces challenges as it expands”

12-08-2014

A federal program that provides billions in drug discounts to safety net hospitals and other health care…

FinancialHealthHealth Medical PharmaHealthcarePharmaceuticalPharmaceutical industryPharmacologyRANDRegulationUSA

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

10-07-2014

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention…

Kenneth MandlNeurologicalPharmaceuticalPharmacologyPharmacovigilanceRegulationRitalinUSA

Actavis and Forest to divest four generics to gain FTC OK for merger

01-07-2014

In order for Ireland-headquartered generics major Actavis to complete its previously-announced $25 billion…

ActavisForest LaboratoriesGeneric pharmaceuticalsGenericsHealth Medical PharmaMedicinePharmaceutical industryPharmacologyRegulationUSA

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

Orexigen stock falls after FDA extends review of obesity drug

Orexigen stock falls after FDA extends review of obesity drug

11-06-2014

Obesity-focused US biopharmaceutical company Orexigen Therapeutics says that the US Food and Drug Administration…

AnorecticsBiopharmaceuticalCardio-vascularContraveHealth Medical PharmaNB32Orexigen TherapeuticsPharmaceuticalPharmacologyRegulationUSA

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