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US FDA calls for more data on Janssen’s fixed dose diabetes drug

US FDA calls for more data on Janssen’s fixed dose diabetes drug

16-12-2013

US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug…

canagliflozinDiabetesJanssenJohnson & JohnsonmetforminNorth AmericaPharmaceuticalRegulation

US House Budget bill passes, which would also free up FDA user fees

US House Budget bill passes, which would also free up FDA user fees

14-12-2013

The US House of Representatives Budget Committee Chairman Paul Ryan and Senate Budget Committee Chairman…

FinancialLegalNorth AmericaPharmaceutical

Retrophin to acquire Kyalin Biosciences; in-licenses Syntocinon

13-12-2013

In a second takeover bid within a matter of months, USA-based Retrophin announced that it will acquire…

Kyalin BiosciencesLicensingMergers & AcquisitionsNeurologicalNorth AmericaNovartisPharmaceuticalRetrophinSyntocinonWomen's Health

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

13-12-2013

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesForxigaNorth AmericaPharmaceuticalRegulation

Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Orexigen has another go at FDA approval of obesity drug Contrave

Orexigen has another go at FDA approval of obesity drug Contrave

12-12-2013

US biopharma company Orexigen Therapeutics is having another stab at gaining approved for its weight-loss…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

Pfizer tasked with novel vaccine research by US government department

Pfizer tasked with novel vaccine research by US government department

12-12-2013

Pfizer, the world’s largest drugmaker by sales, has been awarded a nearly $7.7 million technology investment…

North AmericaPfizerPharmaceuticalResearchVaccines

Emergent BioSolutions to acquire Cangene for $222 million

12-12-2013

Taking a significant step to solidify its leadership position in the growing biodefense market, US vaccine…

CangeneEmergent BioSolutionsMergers & AcquisitionsNorth AmericaPharmaceuticalVaccines

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

12-12-2013

In an 11 to one vote yesterday, the US Food and Drug Administration’s Endocrinologic and Metabolic…

AstraZenecaBristol-Myers SquibbMetabolicsmetreleptinNorth AmericaPharmaceuticalRare diseasesRegulation

Stallergenes' Oralair gains US FDA panel backing

Stallergenes' Oralair gains US FDA panel backing

12-12-2013

France’s Stallergenes said late yesterday that the Allergenic Products Advisory Committee (APAC) of…

GREER LaboratoriesImmunologicalsNorth AmericaOralairPharmaceuticalRegulationStallergenes

DMC clears Merck & Co’s Alzheimer’s drug MK-8931 development

DMC clears Merck & Co’s Alzheimer’s drug MK-8931 development

10-12-2013

The development program for MK-8931, a novel investigational oral beta-amyloid precursor protein site-cleaving…

Anti-Arthritics/RheumaticsFinancialFosamaxMerck & CoMK-8931NeurologicalNorth AmericaPharmaceuticalResearch

Newron and Zambon file for EU approval of Parkinson’s drug safinamide

09-12-2013

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

EuropeNeurologicalNewron PharmaNorth AmericaPharmaceuticalRegulationsafinamideZambon

United Therapeutics subpoenaed over drug marketing practices

09-12-2013

US drugmaker United Therapeutics says it has received a subpoena from the Office of the Inspector General…

AdcircaLegalMarkets & MarketingNorth AmericaPharmaceuticalRemodulinTyvasoUnited Therapeutics

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 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

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

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

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