Regulation - North America, Patents

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Actavis confirms challenge of Lilly’s Axiron patent

Actavis confirms challenge of Lilly’s Axiron patent

14-11-2013

US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US…

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

Actavis confirms Vimpat patent challenge and gets OK for generic Opana

15-07-2013

US generics major Actavis (NYSE: ACT) confirmed on Friday (July 12) that it has filed an Abbreviated…

ActavisEndo Health SolutionsGenericsLegalNeurologicalNorth AmericaOpana ERPatentsRegulationUCBVimpat

Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst

05-06-2013

Later this month, following an inquiry launched in 2009, the European Commission is expected to impose…

EuropeFinancialGenericsNorth AmericaPatentsPharmaceuticalPoliticsRegulation

US FY 2014 budget continues push to curb patent settlements, shorten biologics exclusivity; a lawyer's view

12-04-2013

At first look, the US Food and Drug Administration appears to have fared rather well under President…

BiotechnologyGenericsNorth AmericaPatentsPoliticsRegulationResearch

Actavis wins generic Pulmicort Respules case; challenges AbbVie patent

02-04-2013

US generic drugs maker Actavis (NYSE: ACT) has confirmed that the US District Court for the District…

AbbVieActavisAndroGelAstraZenecaGenericsMarkets & MarketingMen's HealthNorth AmericaPatentsPulmicort RespulesRegulationRespiratory and Pulmonary

Actavis confirms patent challenge to Endo's Fortesta

04-03-2013

Generics drug giant Actavis (NYSE: ACT, formerly trading as Watson) has confirmed filing an Abbreviated…

ActavisEndo PharmaceuticalsFortestaGenericsMen's HealthNorth AmericaPatentsRegulation

Actavis settles with Mallinckrodt over Exalgo 32mg; Teva gains FDA OK for Adderall XR

14-02-2013

US generics drug major Actavis (NYSE: ACT) has reached a settlement with Mallinckrodt (NYSE: MKG) on…

ActavisAdderall XRExalgoGenericsMallinckrodtNeurologicalNorth AmericaPatentsRegulationShireTeva Pharmaceutical Industries

Regulatory news for Hyperion's Ravicti and Seattle Genetics' Adcetris

04-02-2013

The US Food and Drug Administration on Friday approved Hyperion Therapeutics' (Nasdaq: HPTX) Ravicti…

AdcetrisBiotechnologyHyperion TherapeuticsNorth AmericaOncologyPatentsPharmaceuticalRare diseasesRavictiRegulationSeattle Genetics

"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions

07-11-2012

The US Food and Drug Administration recently announced that the agency has established within the Center…

BiotechnologyLegalNorth AmericaPatentsPharmaceuticalRegulation

FDA approves Teva's Synribo for CML; Novartis plans for Tasigna switch

29-10-2012

The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries'…

GleevecNorth AmericaNovartisOncologyPatentsPharmaceuticalRegulationResearchSynriboTasignaTeva Pharmaceutical Industries

US and Indian biotech industry find common ground on key issues

13-09-2012

The third annual BIO India conference kicked off yesterday in Mumbai with significant agreement among…

Asia-PacificBiotechnologyNorth AmericaPatentsRegulationResearch

Shire's Dermagraft cleared in Canada; settles Intuniv litigation

06-09-2012

Ireland headquartered Shire (LSE: SHP), NASDAQ: SHPG) says that its lead regenerative medicine product,…

Anchen PharmaceuticalsDermagraftDermatologicalsDiabetesGenericsIntunivNeurologicalNorth AmericaPatentsPharmaceuticalRegulationShireTWi Pharmaceuticals

Global pharmaceutical approvals moderate as patent cliff peaks, says Fitch

26-07-2012

The Food and Drug Administration will approve fewer novel drugs in 2012 compared to 2011 while the industry…

BiotechnologyNorth AmericaPatentsPharmaceuticalRegulation

Watson challenges Pfizer's Pristiq patent

26-06-2012

US generics drugmaker Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories,…

GenericsNeurologicalNorth AmericaPatentsPfizerPharmaceuticalPristiqRegulationWatson Pharmaceuticals

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