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Mylan starts Ph III trials for generics of Advair Diskus and insulin analog to Lantus

16-09-2014

US generic drugs major Mylan says it is initiating Phase III clinical trials for its generic version…

Advair DiskusDiabetesGenericsGlaxoSmithKlineLantusMylanResearchRespiratory and PulmonarySanofi

Mylan to acquire US rights to Arixtra Injection from Aspen

Mylan to acquire US rights to Arixtra Injection from Aspen

10-09-2014

US generic drugs major Mylan has entered into an agreement to acquire the US commercialization, marketing…

ArixtraAspen PharmacareCardio-vascularGenericsGlaxoSmithKlineMergers & AcquisitionsMylanUSA

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

Mylan wins motion to enjoin GSK from providing paroxetine CR to Apotex

Mylan wins motion to enjoin GSK from providing paroxetine CR to Apotex

17-07-2014

US generics drug major Mylan says that the US District Court for the District of New Jersey granted its…

ApotexGenericsGlaxoSmithKlineLegalMylanNeurologicalparoxetinePaxil-CRUSA

Prosonix and Mylan in deal for Flixotide and Flovent generics

15-04-2014

Prosonix, a UK-based company which is developing a portfolio of inhaled “Respiratory Medicines by Design,”…

FloventGenericsGlaxoSmithKlineGlobalLicensingMylan LaboratoriesProsonixRespiratory and Pulmonary

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

Mylan prevails in breach of contract case against GlaxoSmithKline

Mylan prevails in breach of contract case against GlaxoSmithKline

27-03-2014

US generics major Mylan reveals that, after a trial in the US District Court for the District of New…

GenericsGlaxoSmithKlineLegalMylan LaboratoriesNeurologicalparoxetinePaxil-CR

India/USA trade dispute could impact AIDS treatment programs

10-03-2014

The trade dispute over intellectual property rights between the USA and India is set to derail the distribution…

Anti-viralsCiplaGenericsGilead SciencesGlaxoSmithKlineIndiaPatentsPricingUSA

Mixed US court decision on ViiV Healthcare’s Epzicom and Trizivir patents

19-12-2013

UK pharma giant GlaxoSmithKline and ViiV Healthcare confirmed that the US District Court for the District…

Anti-viralsEpzicomGenericsGlaxoSmithKlineLegalLupinPatentsTeva Pharmaceutical IndustriesTrizivirViiV Healthcare

US Appeals Court reverses 2012 decision on Lovaza, clearing way for generics

13-09-2013

Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals…

AmarinCardio-vascularGenericsGlaxoSmithKlineLegalLovazaNorth AmericaPar PharmaceuticalsPatentsPharmaceuticalTeva Pharmaceutical IndustriesVascepa

Mylan cleared to sell generic Wellbutrin XL in USA

26-08-2013

There was good news last week for US specialty and generics company Mylan (Nasdaq: MYL), when the US…

GenericsGlaxoSmithKlineMylan LaboratoriesNeurologicalNorth AmericaRegulationWellbutrin XL

US appeals court reverses paroxetine order in favor of Mylan

23-07-2013

US generic drugmaker Mylan (Nasdaq: MYL) today (July 23) announced that the US Third Circuit Court of…

ApotexGenericsGlaxoSmithKlineLegalMylan LaboratoriesNeurologicalNorth AmericaparoxetinePatentsPaxil

UK's OFT accuses GlaxoSmithKline of "market abuse"

19-04-2013

The UK's Office of Fair Trading (OFT) today (April 19) issued a Statement of Objections to certain pharmaceutical…

AlpharmaEuropeGenericsGlaxoSmithKlineLegalMarkets & MarketingNeurologicalNorton HealthcarePaxilPharmaceuticalPricingSeroxat

GlaxoSmithKline and A*STAR's ICES to develop medicines for emerging markets

09-04-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and Singapore-based A*STAR's Institute of Chemical and Engineering…

GenericsGlaxoSmithKlineGlobalPharmaceuticalResearch

Sales of antiretroviral agents for HIV will decline slightly over next decade

18-12-2012

Major-market sales of antiretroviral (ARV) agents for HIV will decline slightly over the next decade,…

Anti-viralsBiotechnologydolutegravirGenericsGlaxoSmithKlineGlobalMarkets & MarketingPharmaceuticalRegulationViiV Healthcare

India's Elder Pharma to enter EU markets; comment on GSK Indian OTC moves

26-11-2012

Indian drugmaker Elder Pharmaceuticals says it is ready to enter the European Union market following…

Asia-PacificdiosminElder PharmaceuticalsEuropeGenericsGlaxoSmithKlineMarkets & MarketingMergers & AcquisitionsPharmaceuticalRegulation

Teva/Impax generic Wellbutrin XL 300mg pulled from US market on non-bioequivalence grounds

04-10-2012

Following a review of new data, the US Food and Drug Administration says these indicate that Budeprion…

Bupropion HclGenericsGlaxoSmithKlineImpax LaboratoriesNeurologicalNorth AmericaRegulationTeva Pharmaceutical IndustriesWellbutrin XL

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

Mylan debuts generic Epivir in Europe; gets Canadian OK for Tracleer copy

07-06-2012

US generic drugs major Mylan (Nasdaq: MYL) says that its UK and Italy-based subsidiaries have launched…

ActelionAnti-viralsEpivirEuropeGenericsGlaxoSmithKlineMarkets & MarketingMylan LaboratoriesNorth AmericaRegulationRespiratory and PulmonaryTracleer

News briefs: Genmab/GSK, Gilead and Mylan

24-05-2012

Denmark's Genmab (OMX: GEN) yesterday received a milestone payment of 20 million Danish kroner ($3.4…

Anti-viralsBiotechnologycobicistatFinancialGenericsGenmabGilead SciencesGlaxoSmithKlineMylan LaboratoriesOncologyRegulationViramune

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