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FTC imposes conditions on Akorn’s proposed buy of Hi-Tech Pharmacal

15-04-2014

In order to consummate the proposed $640 million acquisition of Hi-Tech Pharmacal by fellow USA-based…

ActavisAkornGenericsHi-Tech PharmacalMergers & AcquisitionsNorth AmericaUSA

Depomed settlements with two Gralise ANDA filers

15-04-2014

US specialty drugmaker Depomed has entered into settlement agreements with two of the three defendants…

DepomedGenericsGraliseIncepta PharmaceuticalsLegalNeurologicalNorth AmericaPatentsUSAZydus Cadila

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

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

Actavis prevails in Lialda patent dispute in USA

Actavis prevails in Lialda patent dispute in USA

31-03-2014

US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower…

ActavisGastro-intestinalsGenericsLegalLialdaNorth AmericaPatentsShireUSA

US FDA approves NDA from Actavis and Valeant

US FDA approves NDA from Actavis and Valeant

26-03-2014

US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration…

ActavisCanadaGenericsMetronidazolePharmaceuticalRegulationUSAValeant PharmaceuticalsWomen's Health

Lupin launches generic Niaspan in USA

24-03-2014

Indian drugmaker Lupin says that its US subsidiary has launched its niacin extended-release tablets USP,…

AbbVieCardio-vascularGenericsLupinMarkets & MarketingNiaspanNorth AmericaUSA

Actavis in Daytrana patent settlement

Actavis in Daytrana patent settlement

20-03-2014

Generic drugs major Actavis has entered into an agreement with Noven Pharmaceuticals, a subsidiary of…

ActavisDaytranaGenericsHisamitsu PharmaLegalNeurologicalNorth AmericaNoven PharmaceuticalsPatentsUSA

Pfizer tackles Torrent over generic Viagra

Pfizer tackles Torrent over generic Viagra

19-03-2014

US pharma giant Pfizer is taking legal action against Indian drugmaker Torrent Pharmaceuticals to stop…

GenericsIndiaLegalMen's HealthPfizerPharmaceuticalTorrent PharmaceuticalsUSAViagra

Teva agrees $27.6 million settlement with US Justice Dept

Teva agrees $27.6 million settlement with US Justice Dept

12-03-2014

US subsidiaries of Israeli generics giant Teva Pharmaceutical Industries have agreed to pay the US government…

ClozapineFinancialGenericsIvaxLegalNeurologicalNorth AmericaTeva Pharmaceutical IndustriesUSA

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

PhRMA slams US President’s claims that Budget invests in innovation

06-03-2014

Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive John Castellani…

GenericsNorth AmericaPatentsPharmaceuticalPoliticsResearchUSA

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

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

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines

27-02-2014

US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

FDA proposed rule to change label requirements would cause dangerous confusion, raise costs

24-02-2014

The Food and Drug Administration’s Proposed Rule to change prescription drug label requirements risks…

GenericsNorth AmericaRegulationUSA

US GPhA member support for GDUFA promise and progress

US GPhA member support for GDUFA promise and progress

21-02-2014

The US Food and Drug Administration’ Office of Generic Drugs acting director Kathleen Uhl, highlighted…

GenericsNorth AmericaRegulationUSA

New data shows FDA’s proposed generic labeling rules would add to health costs

New data shows FDA’s proposed generic labeling rules would add to health costs

06-02-2014

The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion…

FinancialGenericsNorth AmericaRegulationUSA

US health advocacy groups state case on biosimilars naming policy

04-02-2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health…

BiosimilarsGenericsNorth AmericaRegulationUSA

Actavis confirms generic Treanda patent challenge

Actavis confirms generic Treanda patent challenge

04-02-2014

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

ActavisCephalonGenericsNorth AmericaOncologyPatentsTeva Pharmaceutical IndustriesTreandaUSA

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