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Gilead submits for approval of hepatitis C drug Sovaldi in Japan

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

27-06-2014

US biotech firm Gilead Sciences revealed this morning it has submitted a New Drug Application to Japan's…

Anti-viralsBiotechnologyGilead SciencesJapanRegulationSovaldi

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

27-06-2014

UK health care watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Eisai files first marketing application for lenvatinib in Japan

Eisai files first marketing application for lenvatinib in Japan

26-06-2014

Japanese pharma major Eisai said today that it has submitted its first marketing authorization application…

EisaiJapanlenvatinibOncologyPharmaceuticalRegulation

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

Negative view from FDA advisory for AstraZeneca’s olaparib

Negative view from FDA advisory for AstraZeneca’s olaparib

26-06-2014

There was disappointment for Anglo-Swedish pharma major AstraZeneca yesterday when a US Food and Drug…

AstraZenecaLynparzaolaparibOncologyPharmaceuticalRegulationUSA

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

25-06-2014

US specialty pharma firm Insys Therapeutics says that the US Food and Drug Administration has granted…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

FDA review of CV risks for diabetics taking olmesartan not conclusive

FDA review of CV risks for diabetics taking olmesartan not conclusive

25-06-2014

The US Food and Drug Administration has completed its safety review and has found no clear evidence of…

BenicarCardio-vascularDaiichi SankyoDiabetesolmesartanPharmaceuticalRegulationUSA

Outcome report on first European collaboration between regulators and HTA organizations

Outcome report on first European collaboration between regulators and HTA organizations

25-06-2014

The report of an initiative undertaken jointly by the European Medicines Agency and the European network…

EuropePharmaceuticalRegulation

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

25-06-2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued new final guidance recommending…

DiabetesInvokanaJanssenPharmaceuticalRegulationUK

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

23-06-2014

The US Food and Drug Administration is warning that the intravenous chemotherapy drug docetaxel contains…

docetaxelOncologyPharmaceuticalRegulationUSA

Alimera’s Iluvien is granted marketing authorization for DME in Italy

Alimera’s Iluvien is granted marketing authorization for DME in Italy

23-06-2014

The Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization for Iluvien…

Alimera SciencesIluvienItalyOphthalmicsPharmaceuticalRegulation

Russian government plans to cut number of generics; controls on MNCs

Russian government plans to cut number of generics; controls on MNCs

23-06-2014

The number of drugs in the Russian market will decline significantly over the next several years, due…

GenericsPricingRegulationRussia

Ivabradine and CV events in angina patients under review in Australia

Ivabradine and CV events in angina patients under review in Australia

23-06-2014

Australian pharma regulator the Therapeutic Goods Administration (TGA) is reviewing new information regarding…

AustraliaCardio-vascularCoralanivabradinePharmaceuticalRegulationServier

Cyprus drugmakers to disclose transfers of value to health care professionals

Cyprus drugmakers to disclose transfers of value to health care professionals

23-06-2014

Pharmaceutical companies in Cyprus will disclose transfers of value to health care professionals, as…

Markets & MarketingPharmaceuticalRegulationRest of the World

PhRMA and EFPIA commissioned report on HTAs finds concerns over speed and transparency

PhRMA and EFPIA commissioned report on HTAs finds concerns over speed and transparency

23-06-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced the release of a report…

PharmaceuticalRegulationUSA

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

Cubist’s Sivextro gets FDA approval for serious skin infections

Cubist’s Sivextro gets FDA approval for serious skin infections

22-06-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsPharmaceuticalRegulationSivextroUSA

FDA adding general warning to testosterone products potential for venous blood clots

FDA adding general warning to testosterone products potential for venous blood clots

22-06-2014

The US Food and Drug Administration is requiring manufacturers to include a general warning in the drug…

Men's HealthPharmaceuticalRegulationTestosteroneUSA

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

20-06-2014

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral…

BayerJapanNexavarOncologyPharmaceuticalRegulation

UK’s NICE draft guidance recommends Lilly’s Efient

UK’s NICE draft guidance recommends Lilly’s Efient

20-06-2014

UK health care watchdog the National Institute for Health and Care Excellence (NICE) has today published…

Cardio-vascularEfientEli LillyPharmaceuticalPricingRegulationUK

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

20-06-2014

The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining…

CelgeneGenericsLegalMylanPharmaceuticalRegulationUSA

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