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Apricus Biosciences gains two more approvals for ED drug Vitaros


USA-based Apricus Biosciences (Nasdaq: APRI) says that the Irish Medicines Board and the Netherlands'…

Apricus BioscienceEuropeMen's HealthPharmaceuticalRegulationReproductiveVitaros

US FDA approval for Warner Chilcott's new oral contraceptive


The US Food and Drug Administration have approved the use of a new oral contraceptive from Ireland-based…

ActavisLo Minastrin FeNorth AmericaPharmaceuticalRegulationReproductiveWarner Chilcott

Vivus partners with Menarini for European and Australia/NZ marketing of ED drug


US drugmaker Vivus (Nasdaq: VVUS) has entered into a license and commercialization agreement and a supply…

Asia-PacificavanafilEuropeLicensingMarkets & MarketingMen's HealthMenariniPharmaceuticalReproductiveSpedraVivus

European approval for Vivus' ED drug Spedra


The European Commission yesterday (June 26) has granted marketing authorization for USA-based Vivus'…

avanafilEuropeMen's HealthPharmaceuticalRegulationReproductiveSpedraVivus

Teva and Actavis debut generic Viagra in Europe


The patent on Viagra (sildenafil) expired last Friday (June 21) in the UK and some other European countries,…

ActavisEuropeGenericsMarkets & MarketingMen's HealthReproductivesildenafilTeva Pharmaceutical IndustriesViagra

FDA approves Plan B One-Step emergency contraceptive for OTC use by women of child-bearing potential


The US Food and Drug Administration has approved the use of Plan B One-Step (levonorgestrel), from Israel-headquartered…

North AmericaPharmaceuticalPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

Actavis confirms patent challenge on Bayer's Safyral


USA-based generics major Actavis (NYSE: ACT) yesterday (June 5) confirmed that it has filed an Abbreviated…

ActavisBayerGenericsPatentsRegulationReproductiveSafyralWomen's Health

Bayer to acquire Conceptus for about $1.1 billion


German drugs and chemical major Bayer (BAYN: DE) has signed an agreement to acquire Conceptus (Nasdaq:…

BayerConceptusEssureMergers & AcquisitionsPharmaceuticalReproductiveWomen's Health

AEterna Zentaris transfers Cetrotide rights to Merck KGaA


Canada's AEterna Zentaris (TSX: AEZ) says that its German subsidiary has entered into binding agreements…

AEterna ZentarisCetrotideLicensingMerck KGaAMerck SeronoPharmaceuticalReproductive

Columbia Labs extends ex-US Crinone accord with Merck Serono into 2020


USA-based Columbia Laboratories (Nasdaq: CBRX) has amended its license and supply agreement with Merck…

Columbia LaboratoriesCrinoneLicensingMerck KGaAMerck SeronoPharmaceuticalReproductive

US federal judge tells FDA to lift age restrictions on morning-after pill


A US federal judge has ordered the Food and Drug Administration to lift age and other restrictions on…

LegalPharmaceuticalPlan BReproductiveTeva Pharmaceutical IndustriesWomen's Health

US FDA approves Teva's oral contraceptive Quartette


There was good news for Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) when the US Food…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

New chemo drug gentler on fertility, tougher on cancer


A new gentler chemotherapy drug in the form of nanoparticles has been designed by Northwestern Medicine…


French medicines regulator takes Bayer acne drug Diane-35 off market


Following a recent investigation (The Pharma Letter January 29), the French medicines agency (ANSM) announced…

BayerDermatologicalsDiane-35EuropePharmaceuticalReproductiveWomen's Health

EMA to review third- and fourth-generation combined OCs; France investigates Diane-35


The European Medicines Agency has been asked by France to review third- and fourth-generation combined…

BayerDermatologicalsDiane-35EuropePharmaceuticalRegulationReproductiveWomen's Health

EMA Pharmacovigilance committee calls for Tredaptive suspension; contraceptives update


At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

Cardio-vascularEuropeMerck & CoNeurologicalPharmaceuticalRegulationReproductivetetrazepamTredaptive

Bayer's long-term contraceptive IUD Skyla gets US FDA approval


The US Food and Drug Administration has approved German drug major Bayer's (BAYN: DE) Skyla (levonorgestrel-releasing…

BayerNorth AmericaPharmaceuticalRegulationReproductiveSkylaWomen's Health

Bayer expects EU launch of new long-term contraceptive system Jaydess in 2nd-qtr 2013


German drug major Bayer (BAYN: DE) has successfully concluded the European Union registration procedure…

BayerEuropeJaydessLevonorgestrelMarkets & MarketingPharmaceuticalRegulationReproductive

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