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ASH 2013: Meeting highlights from Takeda, Roche, Novartis and Gilead

ASH 2013: Meeting highlights from Takeda, Roche, Novartis and Gilead

09-12-2013

The 55th American Society of Hematology (ASH) meeting began in New Orleans on Saturday with a host of…

Gilead SciencesNorth AmericaNovartisPharmaceuticalResearchRocheTakeda Pharmaceuticals

US FDA approval for Gilead's hepatitis C drug Sovaldi

US FDA approval for Gilead's hepatitis C drug Sovaldi

08-12-2013

US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPricingRegulationsofosbuvirSovaldi

US FDA approves first drug treatment for Peyronie’s disease

US FDA approves first drug treatment for Peyronie’s disease

07-12-2013

The US Food and Drug Administration has approved a new use for US company Auxilium Pharmaceuticals Xiaflex…

Auxilium PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationXiaflex

Review of key drivers of migraine market growth through 2022

06-12-2013

Use of Allergan’s Botox (botulinum toxin type A) for the prophylactic treatment of chronic migraine…

AllerganAsia-PacificBotoxCoLucid PharmaceuticalsEuropelasmiditanLevadexMarkets & MarketingNeurologicalNorth AmericaPharmaceutical

FDA warns of serious skin reactions with the anti-seizure drug Onfi

FDA warns of serious skin reactions with the anti-seizure drug Onfi

04-12-2013

The US Food and Drug Administration is warning the public that the anti-seizure drug Onfi (clobazam)…

LundbeckNeurologicalNorth AmericaOnfiPharmaceuticalRegulation

US FDA accepts Nova Lab’s filing for mercaptopurine in childhood ALL

US FDA accepts Nova Lab’s filing for mercaptopurine in childhood ALL

04-12-2013

Privately-held UK drugmaker Nova Laboratories says the US Food and Drug Administration has accepted a…

MercaptopurineNorth AmericaNova LaboratoriesPharmaceuticalRare Disease TherapeuticsRare diseasesRegulationXaluprine

USA’s BIO expresses serious concerns on Innovation Act, HR 3309

04-12-2013

The US trade group Biotechnology Industry Organization (BIO) has expressed grave concerns relating to…

BiotechnologyLegalNorth AmericaPatentsPolitics

AstraZeneca wins damages from Apotex

AstraZeneca wins damages from Apotex

04-12-2013

Anglo-Swedish drug major AstraZeneca this morning said it welcomed the US District Court for the Southern…

ApotexAstraZenecaFinancialGastro-intestinalsGenericsNexium I.V.North AmericaPatentsPrilosec

Sandoz in deal to market authorized generic of Shire’s Adderall XR in USA

Sandoz in deal to market authorized generic of Shire’s Adderall XR in USA

03-12-2013

UK drugmaker Shire says that its subsidiary Shire US Inc has entered into an agreement to supply an authorized…

Adderall XRGenericsLicensingNeurologicalNorth AmericaNovartisSandozShire

Forest spends $240 million for US rights to Saphris; streamlines operations

02-12-2013

US drugmaker Forest Laboratories is acquiring exclusive rights in the USA for Saphris (asenapine) sublingual…

FinancialForest LaboratoriesLicensingMerck & CoNeurologicalNorth AmericaPharmaceuticalSaphrisUSA

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

02-12-2013

USA-based Baxter International has completed submission of an amended biologics license application to…

Baxter InternationalHalozyme TherapeuticsHyQviaImmunologicalsNorth AmericaPharmaceuticalRegulationUSA

US FDA delays Alprolix approval

US FDA delays Alprolix approval

02-12-2013

The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act date for…

AlprolixBiogen IdecBiotechnologyHematologyNorth AmericaRegulationSwedish Orphan BiovitrumUSA

Eisai’s R&D organization undergoes “transformation”

Eisai’s R&D organization undergoes “transformation”

30-11-2013

Japanese drugmaker Eisai's president and chief executive, Haruo Naito, says that the company's R&D organization,…

Asia-PacificEisaiEuropeManagementNorth AmericaPharmaceuticalResearchUSA

Health Canada clears AbbVie’s Humira for UC

Health Canada clears AbbVie’s Humira for UC

28-11-2013

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker…

AbbVieAnti-Arthritics/RheumaticsGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

AHF sues Abbott and AbbVie for overcharging on AIDS drug pricing

AHF sues Abbott and AbbVie for overcharging on AIDS drug pricing

28-11-2013

In further legal action against drugmakers allegedly over pricing AIDS drugs in the USA, the AIDS Healthcare…

Abbott LaboratoriesAbbVieAnti-viralsKaletra TabletsLegalNorth AmericaNorvirPharmaceuticalPricing

Teva gains additional regulatory exclusivity for Treanda

Teva gains additional regulatory exclusivity for Treanda

28-11-2013

Israel-based global generic giant Teva Pharmaceutical Industries has been granted orphan drug exclusivity…

North AmericaOncologyPharmaceuticalRegulationTeva Pharmaceutical IndustriesTreanda

FDA accepts priority review of Durata NDA for Dalvance

FDA accepts priority review of Durata NDA for Dalvance

27-11-2013

Shares of Durata Therapeutics leapt 13.4%, following the news that the New Drug Application for its investigational…

Antibiotics and Infectious diseasesCubicinDalvanceDurata TherapeuticsNorth AmericaPharmaceuticalRegulation

US patient share leaders in first-line BRAF-mutation positive malignant melanoma

27-11-2013

According to US oncologists surveyed in the third quarter of 2013 by BioTrends Research, a unit of Decision…

Bristol-Myers SquibbGlaxoSmithKlineMarkets & MarketingMekinistNorth AmericaOncologyPharmaceuticalRocheTafinlarYervoyZelboraf

US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

No changes in Australian domestic IP warranted, say generic drugmakers

No changes in Australian domestic IP warranted, say generic drugmakers

26-11-2013

Members of the generic drugs industry are calling on the Australian government to support efforts to…

Asia-PacificGenericsNorth AmericaPatentsPolitics

US FDA eases restrictions on GSK diabetes drug Avandia

US FDA eases restrictions on GSK diabetes drug Avandia

26-11-2013

The US Food and Drug Administration yesterday (November 25) lifted some severe limitations on the prescribing…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Orexigen to resubmit US NDA for obesity drug Contrave

26-11-2013

Along with presenting new data for its weight loss drug candidate Contrave (naltrexone SR and bupropion…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

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