Pharmaceutical - Pharmaceutical, North America, Cardio-vascular

1 to 25 of 98 results

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Servier Canada collaborates in two research projects

Servier Canada collaborates in two research projects

17-02-2014

Two major projects in clinical research conducted by Canada’s Montreal Heart Institute (MHI) and the…

CanadaCardio-vascularFinancialNorth AmericaPharmaceuticalResearchServier

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

10-01-2014

Japanese drug major Daiichi Sankyo has filed a New Drug Application for its investigational, oral, once-daily…

Cardio-vascularCeldara MedicalDaiichi SankyoedoxabanNorth AmericaPharmaceuticalRegulationResearchSavaysaUSAVirtici

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

10-01-2014

Swiss drug major Novartis faced two problems yesterday, when the Japanese Ministry of Health Labor and…

Asia-PacificCardio-vascularDiovanExjadeHematologyLegalMarkets & MarketingNorth AmericaNovartisPharmaceuticalUSA

Novel oral anticoagulants will continue to drive atrial fibrillation drug market growth

20-12-2013

The atrial fibrillation drug market will experience continued growth through the rest of the decade,…

Asia-PacificBayerBoehringer IngelheimBristol-Myers SquibbCardio-vascularEliquisEuropeMarkets & MarketingNorth AmericaPfizerPharmaceuticalPradaxaXarelto

“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

FDA says PCSK9 inhibitors may not require outcome studies

FDA says PCSK9 inhibitors may not require outcome studies

18-11-2013

The US Food and Drug Administration has said that pharma companies developing PCSK9 inhibitors will not…

Cardio-vascularNorth AmericaPharmaceuticalRegulationUSA

Actelion receives Health Canada approval of Opsumit for PAH

Actelion receives Health Canada approval of Opsumit for PAH

13-11-2013

Swiss biotech firm Actelion (SIX: ATLN) says that Canada’s regulator Health Canada has approved its…

ActelionCanadaCardio-vascularNorth AmericaOpsumitPharmaceuticalRegulation

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

Amarin cuts 50% of staff after negative FDA decision

23-10-2013

Amarin has announced plans to cut 50% of its staff worldwide after the recent US Food and Drug Administration…

AmarinCardio-vascularFinancialManagementNorth AmericaPharmaceuticalVascepa

Oxygen Biotherapeutics signs agreement to acquire Phase III cardiac drug from Phyxius Pharma

22-10-2013

US drug developer Oxygen Biotherapeutics has signed a Definitive Agreement to acquire certain assets…

Cardio-vascularLevosimendanLicensingMergers & AcquisitionsNorth AmericaOxygen BiotherapeuticsPharmaceutical

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

Lyxumia's delayed entrance into US anti-diabetes drug market could prove successful in the future, says GlobalData's analyst

18-09-2013

French drug major Sanofi's (Euronext: SAN) decision to withdraw Lyxumia's (lixisenatide)...

BiotechnologyCardio-vascularDiabetesLyxumiaNorth AmericaPharmaceuticalRegulationResearchSanofi

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

Takeda out-licenses Edarbi and Edarbyclor

13-09-2013

Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) has entered into a license, development and…

Arbor PharmaceuticalsCardio-vascularEdarbiEdarbyclorLicensingNorth AmericaPharmaceuticalTakeda Pharmaceuticals

US Appeals Court reverses 2012 decision on Lovaza, clearing way for generics

13-09-2013

Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals…

AmarinCardio-vascularGenericsGlaxoSmithKlineLegalLovazaNorth AmericaPar PharmaceuticalsPatentsPharmaceuticalTeva Pharmaceutical IndustriesVascepa

Sanofi US in deal to commercialize PA8140/PA32540

04-09-2013

The US subsidiary of French drug major Sanofi (Euronext: SAN) has entered into a deal with US drugmaker…

AspirinCardio-vascularGastro-intestinalsLicensingNorth AmericaOmeprazolePharmaceuticalPozenSanofi

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