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EMA explains its redaction rules, responding to Ombudsman questions

EMA explains its redaction rules, responding to Ombudsman questions

11-02-2015

The European Medicines Agency has published a detailed response to the European Ombudsman’s questions…

AbbVieEuropeHumiraPharmaceuticalRegulation

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

10-02-2015

US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner…

BayerGenericsLegalMylanNexavarOncologyOnyx PharmaceuticalsPatentsPatents & Trade marksRegulationUSA

Celgene's Abraxane recommended by Scottish Medicines Consortium

Celgene's Abraxane recommended by Scottish Medicines Consortium

10-02-2015

The Scottish Medicines Consortium has decided to recommend Abraxane (paclitaxel) in combination with…

AbraxaneBiotechnologyCelgene CorpOncologyRegulationUK

Revised FDA Draft Guidance for consumer-directed promotional Rx drug labeling

Revised FDA Draft Guidance for consumer-directed promotional Rx drug labeling

09-02-2015

The US Food and Drug administration has released revised draft guidance for industry, “Brief Summary…

Markets & MarketingPharmaceuticalRegulationUSA

US FDA issues another warning letter over failures at Apotex’ Indian plant

US FDA issues another warning letter over failures at Apotex’ Indian plant

09-02-2015

The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics…

ApotexApotex Research Private LimitedGenericsIndiaProductionRegulationUSA

Janssen disappointed at SMC decision on Zytiga

09-02-2015

Janssen, a UK-based subsidiary of US health care giant Johnson & Johnson is disappointed with the Scottish…

JanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationUKZytiga

CHMP issues positive opinion on new schedule for Sanofi Pasteur's Hexyon

CHMP issues positive opinion on new schedule for Sanofi Pasteur's Hexyon

09-02-2015

The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on an…

EuropeHexyonPharmaceuticalRegulationSanofi PasteurSanofi Pasteur MSDVaccines

FDA approves added indication for Genentech’s Lucentis

FDA approves added indication for Genentech’s Lucentis

08-02-2015

The US Food and Drug Administration on Friday approved Swiss pharma giant Roche subsidiary Genentech’s…

BiotechnologyGenentechLucentisNovartisOphthalmicsRegulationRocheUSA

US DEA de-schedules AstraZeneca’s Movantik

07-02-2015

The USA’s Drug Enforcement Administration (DEA) has de-scheduled UK pharma major AstraZeneca’s Movantik…

AstraZenecaGastro-intestinalsMovantiknaloxegolNektar TherapeuticsPharmaceuticalRegulationUSA

GSK files for EU expanded indication for Revolade

GSK files for EU expanded indication for Revolade

06-02-2015

UK pharma major GlaxoSmithKline has filed a submission with the European Medicines Agency for a variation…

eltrombopagEuropeGlaxoSmithKlinePharmaceuticalRare diseasesRegulationRevolade

European Commission approves added indication for Janssen’s Velcade, in MCL

European Commission approves added indication for Janssen’s Velcade, in MCL

06-02-2015

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV (Janssen)…

BiotechnologyEuropeJanssen-Cilag InternationalJohnson & JohnsonOncologyRegulationVelcade

IQWiG finds no added benefit for Latuda in schizophrenia

IQWiG finds no added benefit for Latuda in schizophrenia

06-02-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination…

GermanyLatudaOncologyPharmaceuticalPricingRegulationSumitomo DainipponTakeda Pharmaceutical

FDA Commissioner Hamburg confirms she is resigning

FDA Commissioner Hamburg confirms she is resigning

06-02-2015

After a day of rumor and speculation, late yesterday US Food and Drug Administration Commissioner Margaret…

ManagementPharmaceuticalRegulationUSA

IQWiG sees benefits for Triumeq and Eperzan

05-02-2015

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has announced its latest findings…

Anti-viralsDiabetesEperzanGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTriumeqViiV Healthcare

Early FDA approval for Pfizer breast cancer drug Ibrance

Early FDA approval for Pfizer breast cancer drug Ibrance

04-02-2015

The US Food and Drug Administration yesterday granted accelerated approval for pharma giant Pfizer’s…

IbranceOncologyPfizerPharmaceuticalRegulationUSA

Novartis' Japan unit faces 15-day suspension over trial data manipulation

Novartis' Japan unit faces 15-day suspension over trial data manipulation

04-02-2015

The Japanese unit of Swiss drug major Novartis is facing suspension following allegations of data manipulation…

DiovanHematologyJapanLegalNovartis PharmaceuticalsOncologyPharmaceuticalRegulation

Arena and Ildong receive marketing authorization for obesity drug Belviq in South Korea

Arena and Ildong receive marketing authorization for obesity drug Belviq in South Korea

03-02-2015

US biopharma company Arena Pharmaceuticals has received marketing authorization in South Korea for Belviq…

Arena PharmaceuticalsBelviqIldong PharmaMetabolicsPharmaceuticalRegulation

US FDA seeks 9% budget hike to $4.9 billion for FY 2016

US FDA seeks 9% budget hike to $4.9 billion for FY 2016

03-02-2015

The US Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the…

FinancialPharmaceuticalRegulationUSA

FDA approves Boehringer Ingelheim and Eli Lilly's Glyxambi for type 2 diabetes

FDA approves Boehringer Ingelheim and Eli Lilly's Glyxambi for type 2 diabetes

02-02-2015

The US Food and Drug Administration has approved Glyxambi (empagliflozin/linagliptin) tablets from German…

Boehringer IngelheimDiabetesEli LillyGlyxambiPharmaceuticalRegulation

SOBI granted marketing authorization for Xiapex in Peyronie's disease in the EU

SOBI granted marketing authorization for Xiapex in Peyronie's disease in the EU

02-02-2015

Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Commission…

Men's HealthPharmaceuticalRegulationSobiXiaflexXiapex

FDA approves Bristol-Myers Squibb's Evotaz in HIV-1

FDA approves Bristol-Myers Squibb's Evotaz in HIV-1

02-02-2015

US drug major Bristol-Myers Squibb has received approval from the US Food and Drug Administration for…

Anti-viralsBristol-Myers SquibbEvotazPharmaceuticalRegulation

Single state body for drug pricing and turnover control soon be established in Ukraine

Single state body for drug pricing and turnover control soon be established in Ukraine

02-02-2015

A single state body for the control of pricing and the turnover of drugs will soon be established in…

PharmaceuticalPricingRegulationSlavicUkraine

Shire’s Vyvanse first FDA-approved drug for binge eating

Shire’s Vyvanse first FDA-approved drug for binge eating

31-01-2015

The US Food and Drug Administration on Friday approved UK drugmaker Shire’s Vyvanse (lisdexamfetamine…

NeurologicalPharmaceuticalRegulationShireUSAVyvanse

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