Regulation - Regulation, Pharmaceutical

Filter

Current filters:

RegulationPharmaceutical

Popular Filters

1 to 25 of 2141 results

Despite limited size, Chile's pharma market offers growing opportunity

23-09-2014

By the end of 2014, the Chilean pharmaceutical market is expected to be worth $2 billion, increasing…

ChileHealthcareMarkets & MarketingPatentsPharmaceuticalRegulation

OxThera’s Oxabact gains orphan drug designation in EU

OxThera’s Oxabact gains orphan drug designation in EU

23-09-2014

Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes)…

EUGastro-intestinalsOxabactOxTheraPharmaceuticalRegulationSweden

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

FDA calls for tighter controls over testosterone replacement therapies

FDA calls for tighter controls over testosterone replacement therapies

19-09-2014

An advisory panel of the US Food and Drug Administration has voted to tighten use of testosterone replacement…

AndrogensAndrologyClarus TherapeuticsEndocrine systemMen's HealthPharmaceuticalRegulationRextoroTestosterone replacementUSA

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

UK NICE consults on draft guidance for hepatitis C drug Olysio

UK NICE consults on draft guidance for hepatitis C drug Olysio

18-09-2014

In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence…

Anti-viralsJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulationUK

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

15-09-2014

Ireland-headquartered drugmaker Shire has received acceptance for its filing with priority review for…

AbbVieIrelandNeurologicalPharmaceuticalRegulationShireVyvanse

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

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

PharmaceuticalPharmacologyRegulationResearchUSA

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

15-09-2014

The pan-European medicines verification system that the European Federation of Pharmaceutical Industries…

EuropeLegitimate supply chainMarkets & MarketingPharmaceuticalRegulation

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14-09-2014

Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company…

AmarinCardio-vascularGlaxoSmithKlineLovazaPharmaceuticalRegulationVascepa

EMA’s PRAC concludes review of Valdoxan/Thymanax

EMA’s PRAC concludes review of Valdoxan/Thymanax

14-09-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular…

EuropeNeurologicalPharmaceuticalRegulationServierThymanaxValdoxan

Further guidance on adaptive licensing pilot project available from EMA

12-09-2014

Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines…

EuropePharmaceuticalRegulation

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

ABPI and Department of Health announce second PPRS payment

ABPI and Department of Health announce second PPRS payment

12-09-2014

The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health have announced…

Association of the British Pharmaceutical IndustryNHS EnglandPharmaceuticalRegulationUK

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

12-09-2014

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when the US Food and drug…

liraglutideMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

1 to 25 of 2141 results

Back to top