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FDA approves Purdue’s opioid analgesic Hysingla ER

21-11-2014

The US Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an extended-release…

Hysingla ERNeurologicalPharmaceuticalPurdue PharmaUSAZogenixZohydro

HHS and NIH take steps to enhance clinical trial results transparency

20-11-2014

The US Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which…

PharmaceuticalRegulationResearchUSA

Shire to relocate 500 employees in formation of new hub in Lexington, Massachusetts

Shire to relocate 500 employees in formation of new hub in Lexington, Massachusetts

19-11-2014

Following AbbVie’s recent abandonment of a $53 billion takeover offer, Ireland-headquartered drugmaker…

Business FinancePharmaceuticalPunctuationShireUSA

Merck & Co’s LDL-lowering drug Vytorin meets study endpoints

Merck & Co’s LDL-lowering drug Vytorin meets study endpoints

18-11-2014

Pharma giant Merck & Co has announced that the study investigating LDL-cholesterol-lowering drug Vytorin…

Cardio-vascularMerck & CoPharmaceuticalResearchUSAVytorinZetia

Extended benefit of dual antiplatelet therapy after one year is proven in study

Extended benefit of dual antiplatelet therapy after one year is proven in study

18-11-2014

New research published in the New England Journal of Medicine shows that while dual antiplatelet therapy…

Cardio-vascularClopidogrelPharmaceuticalprasugrelResearchUSA

Allergan agrees to $66 billion acquisition by Actavis

Allergan agrees to $66 billion acquisition by Actavis

17-11-2014

Confirming what were becoming ever stronger rumors over the weekend, Ireland-headquartered Actavis this…

ActavisAllerganMergers & AcquisitionsPharmaceuticalUSAValeant Pharmaceuticals International

Clear survival benefit for B-MS’ Opdivo in advanced melanoma patients

Clear survival benefit for B-MS’ Opdivo in advanced melanoma patients

17-11-2014

US drug major Bristol-Myers Squibb has announced results from a study comparing Opdivo (nivolumab) to…

Bristol-Myers SquibbOncologyOpdivoPharmaceuticalResearchUSA

Study shows mutations in NPC1L1 protein cut coronary heart disease

Study shows mutations in NPC1L1 protein cut coronary heart disease

14-11-2014

A new study part-funded by US pharma giant Merck & Co (NYSE: MRK) has found that mutations in a gene…

Cardio-vascularCoronary heart diseaseMerck & CoPharmaceuticalResearchUnited StatesUSAZetia

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

13-11-2014

Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug…

HematologyPar PharmaceuticalsPharmaceuticalRegulationUSAVasostrict

Merck's Phase II trial of grazoprevir/elbasvir in hepatitis C genotype 1 positive

Merck's Phase II trial of grazoprevir/elbasvir in hepatitis C genotype 1 positive

12-11-2014

Pharma giant Merck & Co has presented results from its Phase II trial of grazoprevir/elbasvir, with or…

grazoprevir/elbasvirMerck & CoNephrology and HepatologyPharmaceuticalResearchUSA

Polyphor’s POL7080 receives QIDP designation from the FDA

12-11-2014

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated…

Antibiotics and Infectious diseasesPharmaceuticalPOL7080PolyphorRegulationRocheUSA

Global melanoma market set to reach $3.6 billion by 2020

12-11-2014

The global melanoma therapeutics market was valued at $1.3 billion in 2013 and will expand at a compound…

Bristol-Myers SquibbEuropeJapanKeytrudaMarkets & MarketingMerck & CoOncologyOpdivoPharmaceuticalUSAYervoy

Afaxys announces wider US availability of ella emergency contraceptive

12-11-2014

US drugmaker Afaxys Pharmaceuticals, a division of Afaxys Inc, has announced wider US availability of…

AfaxysellaHRA PharmaMarkets & MarketingPharmaceuticalReproductiveUSAWomen's Health

Durect to ‘refine the path’ of Posidur program

Durect to ‘refine the path’ of Posidur program

12-11-2014

US drugmaker Durect Corporation says that it has received meeting minutes from its face-to-face meeting…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

New data show strong cure rates with AbbVie’s hep C therapy in HIV and transplant patient studies

New data show strong cure rates with AbbVie’s hep C therapy in HIV and transplant patient studies

11-11-2014

US pharma company AbbVie got a boost for its upcoming hepatitis C treatment regimen, with the company…

AbbVieAnti-viralsPharmaceuticalResearchUSA

Biologics will complement statins in cholesterol treatment space, says GlobalData

Biologics will complement statins in cholesterol treatment space, says GlobalData

11-11-2014

Biologics will play an influential role in shaping the future of cardiovascular drug treatment, in particular…

alirocumabAmgenCardio-vascularevolocumabMarkets & MarketingPharmaceuticalRegeneronSanofiUSA

Merck’s triple-therapy hepatitis C regimen shows sub-optimal efficacy

Merck’s triple-therapy hepatitis C regimen shows sub-optimal efficacy

11-11-2014

US pharma giant Merck & Co has admitted that interim data from its triple-therapy regimen in hepatitis…

Anti-viralsHCVHepatitis CHepatitis C virusMerck & CoPharmaceuticalResearchsofosbuvirUSA

EFPIA and IMI launch 280 million-euro Ebola program, calling for proposals

EFPIA and IMI launch 280 million-euro Ebola program, calling for proposals

10-11-2014

The European Federation of Pharmaceutical Industries and Associations, its specialized group Vaccines…

Anti-viralsEuropeFinancialPharmaceuticalResearchUSA

Dendreon seeks a buyer as it files for bankruptcy

Dendreon seeks a buyer as it files for bankruptcy

10-11-2014

US biotech firm Dendreon has filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the…

DendreonFinancialOncologyPharmaceuticalProvengeUSA

FDA Focus: The Sherley Amendment

FDA Focus: The Sherley Amendment

10-11-2014

In the fourth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

Food and Drug AdministrationPharmaceuticalRegulationUnited StatesUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys

District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys

10-11-2014

The US District Court for the District of Columbia, presiding in a law suit between Japanese drugmaker…

ColcrysGastro-intestinalsHikmaLegalPharmaceuticalTakeda PharmaceuticalUSAWest-Ward

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