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Europe to boost cooperation with international partners on generics

Europe to boost cooperation with international partners on generics

08-08-2014

The European Union’s decentralized procedure is being used as a model to accelerate the assessment…

EuropeEuropean UnionGenericsGlobalRegulation

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

Actavis confirms patent challenge to Duchesnay’s Diclegis

Actavis confirms patent challenge to Duchesnay’s Diclegis

12-07-2014

Ireland-based generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application…

ActavisDiclegisDuchesnayGenericsPatentsRegulationUSAWomen's Health

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

Russian government plans to cut number of generics; controls on MNCs

Russian government plans to cut number of generics; controls on MNCs

23-06-2014

The number of drugs in the Russian market will decline significantly over the next several years, due…

GenericsPricingRegulationRussia

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

20-06-2014

The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining…

CelgeneGenericsLegalMylanPharmaceuticalRegulationUSA

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

Colombia an attractive and fast-growing emerging pharma market

Colombia an attractive and fast-growing emerging pharma market

18-06-2014

The South American country Colombia has an attractive pharmaceutical market that should appeal to multinational…

ColombiaGenericsMarkets & MarketingPricingRegulationSouth America

Australia’s TGA joins EDQM's CEP assessment process

Australia’s TGA joins EDQM's CEP assessment process

17-06-2014

The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the…

AustraliaEuropeGenericsRegulation

Mylan launches generic Paraplatin Injection in USA

Mylan launches generic Paraplatin Injection in USA

09-06-2014

US generics major Mylan has launched carboplatin injection, 50mg/5ml, in multi-dose vials, which is the…

Bristol-Myers SquibbGenericsMarkets & MarketingMylanOncologyParaplatinRegulationUSA

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

05-06-2014

European regulatory authorities have finalized their assessment of reported non-compliance with Good…

EuropeGenericsIndiaProductionRanbaxy LaboratoriesRegulation

Generic and biosimilar drugs should be key components of CSRs for health, says EGA

Generic and biosimilar drugs should be key components of CSRs for health, says EGA

05-06-2014

The increased number of health related proposed country specific recommendations (CSR) to European Union…

BiosimilarsGenericsHealthcareRegulation

European generics group welcomes WHA resolution on biotherapeutics products

04-06-2014

The European Generic Medicines Association (EGA) has welcomed the 67th World Health Assembly’s Resolution…

BiosimilarsGenericsGlobalRegulation

EGA calls for international regulatory cooperation

03-06-2014

European Generics Medicines Association (EGA) Director General Adrian van den Hoven last week joined…

GenericsGlobalPharmaceutical industryRegulationResearch

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