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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

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

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

European and Japanese generics groups view opportunities on biosimilars

European and Japanese generics groups view opportunities on biosimilars

29-05-2014

The European Generic Medicines Association (EGA) participated in several meetings with Japanese government…

BiosimilarsEuropeGenericsJapanMarkets & MarketingRegulation

Congressional hearing in Brazil will discuss the efficacy of generic medicines

26-05-2014

The Brazilian Commission for Consumer Protection will soon hold a hearing to discuss the effectiveness…

BrazilGenericsPoliticsRegulation

Biocad’s AcellBia is first MAb biosimilar approved by Russia’s Ministry of Health

15-05-2014

A biosimilar of Swiss drug major Roche’s MabThera (rituximab), to be marketed under the trade name…

AcellBiaBiocadBiosimilarsGenericsMabTheraOncologyRegulationRocheRussia

Mylan debuts generic Zyprexa Zydis in USA; Actavis Exalgo copy approved

Mylan debuts generic Zyprexa Zydis in USA; Actavis Exalgo copy approved

14-05-2014

US generic drugmaker Mylan says it has launched Olanzapine Orally Disintegrating tablets (ODT), 5mg,…

ActavisEli LillyExalgoGenericsMallinckrodtMarkets & MarketingMylanNeurologicalRegulationUSAZyprexa

Vivus says Actavis has filed ANDA for generic Qsymia

Vivus says Actavis has filed ANDA for generic Qsymia

10-05-2014

US drug developer Vivus disclosed on Friday that the company had received notice from generics major…

ActavisGenericsMetabolicsPatentsQsymiaRegulationUSAVivus

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

30-04-2014

The European Commission has granted marketing authorization for Israel-based Teva Pharmaceutical Industries’…

DuoResp SpiromaxEuropeGenericsRegulationRespiratory and PulmonaryTeva Pharmaceutical Industries

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

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