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Holoclar, the first stem cell-based medicinal product approved in Europe

Holoclar, the first stem cell-based medicinal product approved in Europe

22-02-2015

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004,…

BiotechnologyChiesi FarmaceuticiEuropeHoloclarHolostem Terapie AvanzateOphthalmicsRegulation

Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

European approval for expanded use of Celgene’s Revlimid

20-02-2015

US biotech firm Celgene’s European subsidiary has received approval from the European Commission for…

BiotechnologyCelgene CorpEuropeOncologyRegulationRevlimid

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

20-02-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined data on independent…

BiotechnologyGermanyHematologyNuwiqOctapharmaPricingRegulation

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

EU health stakeholders set up EMVO to help fight counterfeit medicines

EU health stakeholders set up EMVO to help fight counterfeit medicines

20-02-2015

Major European health care stakeholders have taken a major step to secure the legitimate pharmaceutical…

EuropeHealthcarePharmaceuticalRegulation

NICE makes preliminary recommendation on Allergan's Ozurdex for macular edema

NICE makes preliminary recommendation on Allergan's Ozurdex for macular edema

20-02-2015

The UK’s National Institutes of Health and Care Excellence has recommended Ozurdex (dexamethasone),…

AllerganDexamethasoneOphthalmicsOzurdexPharmaceuticalRegulationUK

NICE gives green light to Bayer’s Eylea for DME

20-02-2015

In a preliminary recommendation issued today, England’s health costs watchdog the National Institute…

BayerEyleaOphthalmicsPharmaceuticalPricingRegulationUK

NICE final draft guidance recommends Norgine's Targaxan

NICE final draft guidance recommends Norgine's Targaxan

19-02-2015

The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending…

Nephrology and HepatologyNeurologicalNorginePharmaceuticalRegulationTargaxanUK

Pharma violates own marketing regulations, Swedish study alleges

Pharma violates own marketing regulations, Swedish study alleges

19-02-2015

A new report from Lund University in Sweden claims to show how the pharmaceutical industry, time and…

Markets & MarketingPharmaceuticalRegulationSwedenUK

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

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

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