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FDA approves Myalept, the first drug to treat a rare metabolic disease

FDA approves Myalept, the first drug to treat a rare metabolic disease

26-02-2014

The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy…

AstraZenecaBristol-Myers SquibbmetreleptinMyaleptNorth AmericaPharmaceuticalRare diseasesRegulationUSA

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

09-01-2014

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesFarxigaNorth AmericaPharmaceuticalRegulationUSA

Amneal debuts generic Esomeprazole strontium in USA

07-01-2014

Privately-held US generics drugmaker Amneal Pharmaceuticals has announced the launch of generic esomeprazole…

Amneal PharmaAstraZenecaEsomeprazole MagnesiumGastro-intestinalsGenericsMarkets & MarketingNexiumNorth AmericaUSA

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

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

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

Horizon Pharma gets US rights for Vimovo from AstraZeneca

Horizon Pharma gets US rights for Vimovo from AstraZeneca

19-11-2013

USA-based Horizon Pharma has entered into an agreement to acquire from Anglo-Swedish drug major AstraZeneca…

Anti-Arthritics/RheumaticsAstraZenecaHorizon PharmaLicensingNorth AmericaPharmaceuticalPozenVimovo

US FDA accepts AstraZeneca’s NDA for naloxegol

US FDA accepts AstraZeneca’s NDA for naloxegol

19-11-2013

The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational…

AstraZenecaGastro-intestinalsnaloxegolNektar TherapeuticsNorth AmericaPharmaceuticalRegulation

New ACC and AHA guidelines could increase sales of statins

New ACC and AHA guidelines could increase sales of statins

13-11-2013

New clinical guidelines have been published for the treatment of cholesterol in people at high risk of…

AbbVieAstraZenecaCardio-vascularCrestorHealthcareLipitorMerck & CoNorth AmericaPfizerPharmaceuticalTricorUSAZetia

AstraZeneca’s patent protection for Pulmicort Respules upheld by US court

AstraZeneca’s patent protection for Pulmicort Respules upheld by US court

31-10-2013

The US Court of Appeals for the Federal Circuit has reversed and remanded for further proceedings a trial…

AstraZenecaGenericsLegalNorth AmericaPulmicort Respules

Opioid-induced constipation market expected to see rapid growth by 2017

Opioid-induced constipation market expected to see rapid growth by 2017

13-10-2013

The global market for opioid-induced constipation will increase significantly from $144.42 million in…

AstraZenecabevenopranCubist PharmaceuticalsEuropeGastro-intestinalsMarkets & MarketingnaloxegolNorth AmericaPharmaceuticalRelistorSalix Pharmaceuticals

US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA

03-10-2013

AstraZeneca said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction…

AstraZenecaEsomeprazole MagnesiumGastro-intestinalsHanmi PharmaceuticalLegalNexiumNorth AmericaPharmaceuticalRegulation

US FDA accepts Epanova NDA filing

18-09-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaNorth AmericaOmthera PharmaceuticalsPharmaceuticalRegulation

Rigel shares fall as asthma compound fails to meet primary endpoint

27-08-2013

Shares of USA-based Rigel Pharmaceuticals (Nasdaq: RIGL) fell 10% to $3.27 in morning trading yesterday…

AstraZenecafostamatinibNorth AmericaPharmaceuticalResearchRespiratory and PulmonaryRigel Pharmaceuticals

AstraZeneca to fork out $815 million for rights to anemia drug candidate

31-07-2013

In yet another move to boost its R&D pipeline, Anglo-Swedish drug major AstraZeneca (LSE: AZN) has entered…

Asia-PacificASP1517Astellas PharmaAstraZenecaBiotechnologyFG-4592FibroGenLicensingNephrology and HepatologyNorth AmericaPharmaceuticalResearch

US Appeals Court puts temporary stop on sales of generics of AstraZeneca's Pulmicort Respules

27-05-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced last Friday (May 24) that the US Court of Appeals…

ActavisAstraZenecaGenericsLegalMarkets & MarketingNorth AmericaPharmaceuticalPulmicort RespulesRespiratory and Pulmonary

Impax launches authorized generic of Zomig, as Mylan debuts copy of Tricor in USA

20-05-2013

US drugmaker Impax Laboratories (Nasdaq: IPXL) says that its generics division, Global Pharmaceuticals,…

AbbVieAstraZenecaCardio-vascularGenericsImpax LaboratoriesMarkets & MarketingMylan LaboratoriesNeurologicalNorth AmericaTricorZomig

DC Circuit Court says AstraZeneca not entitled to three-year exclusivity for Seroquel

29-04-2013

In a brief opinion handed down last week by the US Court of Appeals for the District of Columbia Circuit,…

AstraZenecaNeurologicalNorth AmericaPatentsPharmaceuticalSeroquel

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

US Court of Appeals confirms validity of AstraZeneca' Seroquel XR patent

15-02-2013

AstraZeneca announced that, on 14 February 2013, the United States Court of Appeals for the Federal Circuit…

AstraZenecaGenericsLegalNeurologicalNorth AmericaPatentsPharmaceuticalSeroquel XR

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