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Mixed FDA advisory panel views on GSK’s Breo Ellipta

20-03-2015

There was conflicting news yesterday for UK pharma major GlaxoSmithKline and US partner Theravance from…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and Pulmonary

Amicus has positive meeting with EMA and FDA to accelerate approval of Fabry monotherapy

Amicus has positive meeting with EMA and FDA to accelerate approval of Fabry monotherapy

19-03-2015

Amicus Therapeutics has had positive meetings with regulatory authorities in Europe and the USA to discuss…

Amicus TherapeuticsBiotechnologyEuropemigalastatRare diseasesRegulationUSA

FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy

FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy

19-03-2015

French ophthalmic specialist Nicox has been granted orphan drug designation by the US Food and Drug Administration…

GeneticsnaproxcinodNicOxNicOxRegulation

FDA approval for Vertex’ Kalydeco for very young children

18-03-2015

There was good news for US biotech firm Vertex Pharmaceuticals yesterday, when the US Food and Drug Administration…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

Research from IQWiG shows early benefit assessment increases trial data transparency

Research from IQWiG shows early benefit assessment increases trial data transparency

18-03-2015

Research from the German Institute for Quality and Efficiency in Healthcare (IQWiG) published in the…

Efficiency in HealthcareGermanyPharmaceuticalPharmacologyRegulation

Regulatory and HTA scientific advice activities are crucial to SME drug development success

18-03-2015

EuropaBio, the European Association for Bioindustries, and the Deerfield Institute have partnered to…

BiotechnologyEuropeRegulationResearch

Aeolus rockets on US orphan status for AEOL 10150 for IPF

Aeolus rockets on US orphan status for AEOL 10150 for IPF

18-03-2015

Shares of US biotech firm Aeolus Pharmaceuticals leapt 27.9% to $0.32 yesterday, after the company revealed…

AEOL 10150Aeolus PharmaceuticalsBiotechnologyRegulationRespiratory and PulmonaryUSA

EC approves new indication for Novartis’ Jakavi

EC approves new indication for Novartis’ Jakavi

17-03-2015

The European Commission has approved Swiss pharma giant Novartis’ Jakavi (ruxolitinib) for the treatment…

BiotechnologyEuropeIncyte CorpJakafiJakaviNovartisOncologyRegulation

General's Prosecutor Office inspects Russian business of Abbott

16-03-2015

The Russian General's Prosecutor Office has issued a warning to a local firm Veropharm, one of Russia’s…

AbbottGenericsPoliticsRegulationRussiaVeropharm

Actavis' sNDA for Saphris approved by FDA

Actavis' sNDA for Saphris approved by FDA

16-03-2015

The US Food and Drug Administration has approved the supplemental New Drug Application for Saphris (asenapine),…

ActavisNeurologicalPharmaceuticalRegulationSaphrisUSA

FDA again delays decision on Merck’s investigational drug sugammadex

14-03-2015

The US Food and Drug Administration has cancelled the meeting of the Anesthetic and Analgesic Drug Products…

Merck & CoNeurologicalPharmaceuticalRegulationsugammadexUSA

Highlights of EMA’s PRAC March meetings

13-03-2015

The European Medicines Agency has released highlights of the March 9-12 meeting of its Pharmacovigilance…

Anti-Arthritics/RheumaticscodeineEuropeNeurologicalNovartisPharmaceuticalRegulationzoledronic acid

Bristol-Myers’ daclatasvir NDA resubmission accepted by FDA

Bristol-Myers’ daclatasvir NDA resubmission accepted by FDA

13-03-2015

US pharma major Bristol-Myers Squibb says that its resubmitted New Drug Application for daclatasvir (proposed…

Anti-viralsBiotechnologyBristol-Myers SquibbdaclatasvirDaklinzaRegulationsofosbuvirUSA

NICE says Takeda’s Entyvio to get NHS funding approval, if discount agreed

NICE says Takeda’s Entyvio to get NHS funding approval, if discount agreed

13-03-2015

A drug to treat a long-term and often distressing bowel condition is being recommended for routine National…

BiotechnologyEntyvioGastro-intestinalsPricingRegulationTakeda PharmaceuticalUK

ACADIA tanks as it delays Nuplazid filing; CEO retires unexpectedly

ACADIA tanks as it delays Nuplazid filing; CEO retires unexpectedly

12-03-2015

Shares of US biotech firm ACADIA Pharmaceuticals plunged 22% to 34.70 in after-hours trading, after it…

ACADIA PharmaceuticalsBiotechnologyBoardroomNeurologicalNuplazidRegulationResearchUSA

UK’s NICE recommends Stelara for psoriatic arthritis

UK’s NICE recommends Stelara for psoriatic arthritis

12-03-2015

Medicines cost watchdog for England, the National Institute for Health and Clinical Excellence (NICE),…

Anti-Arthritics/RheumaticsBiotechnologyInflammatory diseasesJanssenJohnson & JohnsonRegulationStelaraUK

EC backs expanded approval of Novo Nordisk’s Tresiba for children

EC backs expanded approval of Novo Nordisk’s Tresiba for children

12-03-2015

Danish diabetes care giant Novo Nordisk says that the European Commission has approved the expanded use…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresiba

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

11-03-2015

Confirming an earlier preliminary guidance, medicines cost watchdog for England, the National Institute…

ArzerraGlaxoSmithKlineOncologyPharmaceuticalPricingRegulationUK

Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

11-03-2015

Shares of US biotech firm Egalet Corp rose 3.65% to $14.48 after it said it plans to file a New Drug…

BiotechnologyEgalet CorpEgalet-001NeurologicalRegulationResearchUSA

EMA publishes document accounting for its pharmacovigilance fees

EMA publishes document accounting for its pharmacovigilance fees

11-03-2015

The European Medicines Agency has published a document accounting for its pharmacovigilance fees.

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

11-03-2015

Japanese drug major Eisai has announced that its drug Halaven (eribulin) will remain on the UK's National…

EisaiHalavenOncologyPharmaceuticalRegulationUK

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