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EMA Orphan Drug status for aTyr’s Resolaris in FSHD

18-02-2015

Privately-held US biotech firm aTyr Pharma says that the European Commission has granted Orphan Drug…

ATyr PharmaBiotechnologyEuropeRare diseasesRegulationResolaris

FDA issues new draft documents related to compounding of human drugs

FDA issues new draft documents related to compounding of human drugs

17-02-2015

The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging…

FDAHealthPharmaceuticalPharmaceutical sciencesPharmacologyRegulationSterile compounded drug productsUSA

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

17-02-2015

Privately-held US sexual health specialists Sprout Pharmaceuticals has resubmitted its New Drug Application…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

17-02-2015

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

FDAPharmaceuticalPharmacologyRegulationUSA

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

17-02-2015

Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US…

Bexion PharmaceuticalsBiotechnologyBXQ-350OncologyRegulationSaposin CUSA

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

17-02-2015

Finnish biotech and pharma company Biotie has received a positive opinion from the European Medicines…

BiotechnologyBiotie TherapiesFinlandNephrology and HepatologyRegulation

Novartis' heart failure drug LCZ696 granted FDA priority review

Novartis' heart failure drug LCZ696 granted FDA priority review

14-02-2015

The US Food and Drug Administration has granted priority review designation for combination pill LCZ696…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationsacubitrilUSAvalsartan

Tecfidera, first-line oral treatment for multiple sclerosis, approved in India

13-02-2015

US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for…

Biogen IdecBiotechnologyIndiaNeurologicalRegulationTecfidera

NICE final draft guidance does not recommend pomalidomide for blood cancer

NICE final draft guidance does not recommend pomalidomide for blood cancer

13-02-2015

The England medical costs watchdog the National Institute for Health and Care excellence (NICE) has issued…

BiotechnologyCelgene CorpImnovidOncologypomalidomidePricingRegulationUK

Breckenridge Pharma files ANDA for generic of Sanofi’s Jevtana

12-02-2015

Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application…

Breckenridge PharmaceuticalsGenericsJevtanaOncologyPatentsRegulationSanofiUSA

Further approvals for ThromboGenics’ Jetrea

12-02-2015

Belgian biotech company ThromboGenics, which is focused on developing and commercializing innovative…

AlconArgentinaBiotechnologyIsraelJetreaNovartisOphthalmicsRegulationThromboGenics

Medicines Australia makes submission to the 2015-2016 federal budget

Medicines Australia makes submission to the 2015-2016 federal budget

12-02-2015

Trade body Medicines Australia has made a submission to the 2015-2016 Federal Budget, asking the Australian…

AustraliaMedicines AustraliaPharmaceuticalRegulationSocial Issues

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

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