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Actavis confirms patent challenge on Bayer's Safyral

06-06-2013

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

29-04-2013

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

BayerConceptusEssureMergers & AcquisitionsPharmaceuticalReproductiveWomen's Health

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

01-02-2013

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

29-01-2013

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

BayerDermatologicalsDiane-35EuropePharmaceuticalRegulationReproductiveWomen's Health

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

11-01-2013

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

06-12-2012

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

BayerEuropeJaydessLevonorgestrelMarkets & MarketingPharmaceuticalRegulationReproductive

Bayer's contraceptive Flexyess gets EC backing

10-10-2012

Bayer HealthCare, the drugs unit of Germany's Bayer AG (BAYN: DE), said yesterday that it has received…

BayerdrospirenoneethinylestradiolEuropeFlexyessPharmaceuticalRegulationReproductiveWomen's Health

Bayer files for EU approval of low-dose contraceptive patch

21-09-2012

German drug major Bayer (BAYN: DE) yesterday submitted an application for marketing authorization in…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductiveWomen's Health

Bayer's Xarelto reimbursement backed in Canada; EMA concludes Yvidually arbitration

24-04-2012

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR),…

BayerCardio-vascularEuropeNorth AmericaPharmaceuticalPricingRegulationReproductiveXareltoYvidually

Bayer updates drospirenone-containing COCs labels to reflect VTE risk

11-04-2012

Following a further review of the products by the US Food and Drug Administration , Bayer HealthCare…

BayerBeyazdrospirenoneNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

Watson confirms patent challenge to Bayer’s Beyaz

13-02-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson…

BayerBeyazGenericsNorth AmericaPatentsRegulationReproductiveWatson Pharmaceuticals

US ANDAs filed for generic Beyaz, Isentress and Epivir

12-01-2012

The US Food and Drug Administration says that Abbreviated New Drug Applications have been received by…

Anti-viralsBayerBeyazEpivirGenericsGlaxoSmithKlineIsentressMerck & CoPharmaceuticalRegulationReproductive

Mixed views on drospirenone OCs

09-12-2011

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory…

BayerDrospirenone and EstradiolNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

US FDA communicates concern about drospirenone-containing birth control pills

27-09-2011

The US Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion,…

BayerDrospirenone and Ethinyl EstradiolNorth AmericaPharmaceuticalRegulationReproductiveYasminYaz

Changing the mood of Brazilian antidepressant market; fake Levitra

24-08-2011

The Vice President of Brazil’s Superior Court of Justice (STJ), Minister Felix Fischer, has restored…

BayerGenericsLevitraLexaproLundbeckNeurologicalPharmaceuticalRegulationReproductiveSouth America

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