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Public Citizen urges US FDA to not approve ApoPharma’s iron overload drug


The US Food and Drug Administration should not approve an experimental drug proposed to treat patients…

ApoPharmaApotexdeferiproneFerriproxNorth AmericaOncologyPharmaceuticalRegulation

FDA warns of pulmonary arterial hypertension risk with Bristol-Myers’ Sprycel


The US Food and Drug Administration is warning the public that drug major Bristol-Myers Squibb’s…

Bristol-Myers SquibbNorth AmericaOncologyPharmaceuticalRegulationSprycel

Canada would lose out on generic industry investment by adopting EU pharma proposals, warns CGPA


Canada could face a loss of jobs and investment in its R&D intensive and fast-growing generic pharmaceutical…

GenericsNorth AmericaPatentsPharmaceuticalResearch

US FDA flexible in reviewing therapies for rare diseases, NORD study concludes


The US National Organization for Rare Disorders (NORD) yesterday released a landmark report documenting…

BiotechnologyNorth AmericaPharmaceuticalRare diseasesRegulation

Insmed tumbles as FDA continues hold on Ph III Arikace trial


US biopharmaceutical company Insmed (Nasdaq CM: INSM) saw its share price plunge 32% to $2.95 in morning…

ArikaceBiotechnologyInsmedNorth AmericaPharmaceuticalRegulationResearchRespiratory and Pulmonary

US antitrust body OKs Teva's acquisition of Cephalon, but with divestments


Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) says that the US Federal Trade Commission…

CephalonGenericsLegalMergers & AcquisitionsNorth AmericaPar PharmaceuticalsPharmaceuticalProvigilTeva Pharmaceutical Industries

FDA clears Merck & Co’s combo diabetes/cholesterol therapy Juvisync


The US Food and Drug Administration on Friday approved the marketing of the first combination drug to…

Cardio-vascularDiabetesJanuviaJuvisyncMerck & CoNorth AmericaPharmaceuticalRegulationZocor

Boehringer Ingelheim’s Combivent Respimat Inhalation Spray OKed in USA to replace aerosol


The US Food and Drug Administration has approved German independent drug major Boehringer Ingelheim’s…

Boehringer IngelheimCombiventNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

J&J unit Scios pleads guilty to misbranding Natrecor, paying $85 million fine


Scios, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has pleaded guilty tto a misdemeanor…

Cardio-vascularJohnson & JohnsonLegalNatrecorNorth AmericaPharmaceuticalScios

FDA approves Lilly’s Cialis to treat benign prostatic hyperplasia


The US Food and Drug Administration yesterday approved drug major Eli Lilly’s (NYSE: LLY) Cialis…

CialisEli LillyNorth AmericaPharmaceuticalRegulationReproductive

FDA Commissioner outlines steps to spur biomedical innovation in USA


A blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

Whistleblower complaint alleges Rx drugmakers underpaid US Medicaid rebates


According to a multi-count whistleblower action in the USA, alleging violations of federal and state…

LegalMarkets & MarketingNorth AmericaPharmaceutical

Another Fosamax trial success for Merck & Co


US drugs giant Merck & Co (NYSE: MRK) says that a federal court jury in New York found in its favor in…

Anti-Arthritics/RheumaticsFosamaxLegalMerck & CoNorth AmericaPharmaceutical

US Senators Grassley and Kohl urge action on Sunshine Law regarding industry relations with physicians


US Senators Chuck Grassley (Republican, Iowa) and Herb Kohl (Democrat, Wisconsin) are pressing the Centers…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

Emergent BioSolutions gets $1.25 billion BioThrax order for US government


Emergent BioSolutions (NYSE: EBS) revealed yesterday that it has received an award to supply the US government…

BioThraxEmergent BioSolutionsFinancialMarkets & MarketingNorth AmericaPharmaceuticalVaccines

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