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FDA backs Kalydeco for eight additional mutations that cause cystic fibrosis

22-02-2014

The US Food and Drug Administration approved biotech firm Vertex Pharmaceuticals’ supplemental New…

BiotechnologyKalydecoNorth AmericaRare diseasesRegulationUSAVertex

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

PhRMA opposes proposed rule on US Medicare Advantage & Part D

PhRMA opposes proposed rule on US Medicare Advantage & Part D

20-02-2014

Pharmaceutical Research and Manufacturers of America (PhRMA) stated yesterday that it is opposed to the…

North AmericaPharmaceuticalPoliticsUSA

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

20-02-2014

The US Food and Drug Administration and the European Medicines Agency have set-up a new “cluster”…

EuropeNorth AmericaPharmaceuticalRegulationUSA

FDA accepts The Medicines Company's NDA for oritavancin with priority review

FDA accepts The Medicines Company's NDA for oritavancin with priority review

19-02-2014

The US Food and Drug Administration has accepted the filing of The Medicines Company’s New Drug Application…

Antibiotics and Infectious diseasesNorth AmericaoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

AHF claims victory over FDA on Gilead’s PrEP

19-02-2014

The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

FDA approves Northera for neurogenic orthostatic hypotension

FDA approves Northera for neurogenic orthostatic hypotension

19-02-2014

Shares of US biotech firm Chelsea Therapeutics soared 38% to $6.75 in after-hours trading yesterday,…

BiotechnologyChelsea TherapeuticsDainippon Sumitomo PharmaNorth AmericaNortheraRare diseasesRegulationUSA

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

FDA approves Vimizim to treat rare congenital enzyme disorder

FDA approves Vimizim to treat rare congenital enzyme disorder

17-02-2014

The US Food and Drug Administration on Friday (February 14) approved BioMarin Pharmaceutical’s Vimizim…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

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

Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

Co-payments and co-insurance fees for drugs rise 34% under USA’s Affordable Care Act

Co-payments and co-insurance fees for drugs rise 34% under USA’s Affordable Care Act

14-02-2014

An examination of new health plans from 46 states in the USA revealed that co-payments and co-insurance…

FinancialHealthcareNorth AmericaPharmaceuticalUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Nearly 200 new medicines in development for diabetes by US drugmakers

12-02-2014

The USA’s biopharmaceutical research companies are currently developing 180 innovative new medicines…

DiabetesNorth AmericaPharmaceuticalResearch

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

FDA advisory panel ambivalent on NSAID cardiovascular risk

FDA advisory panel ambivalent on NSAID cardiovascular risk

12-02-2014

The US Food and Drug Administration’s joint Arthritis Advisory Committee and Drug Safety and Risk Management…

Anti-Arthritics/RheumaticsBayerNaproxenNeurologicalNorth AmericaPfizerPharmaceuticalUSA

Report shows weak US oversight of drug discount program for the uninsured

Report shows weak US oversight of drug discount program for the uninsured

07-02-2014

A group of Republican Senate and House lawmakers in the USA released statements in response to a report…

North AmericaPharmaceuticalPoliticsUSA

Whistleblower law suit against Celgene unsealed

Whistleblower law suit against Celgene unsealed

07-02-2014

A US federal court yesterday unsealed a whistleblower/false claims law suit brought against US biotech…

BiotechnologyCelgeneLegalMarkets & MarketingNorth AmericaOncologyRevlimidThalomidUSA

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

Taking a cue from Apple and Coca-Cola, Big Pharma are humanizing brands

05-02-2014

By 2018, it is estimated that the global pharmaceutical market will be worth more than $1.3 trillion.…

Markets & MarketingNorth AmericaPharmaceuticalUSA

US HHS strengthens patients’ right to access lab test reports

US HHS strengthens patients’ right to access lab test reports

05-02-2014

As part of an ongoing effort to empower patients to be informed partners with their health care providers,…

HealthcareNorth AmericaPharmaceuticalRegulationUSA

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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