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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

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

UK NICE to hold oral appeal hearing for Ferring’s Firmagon

UK NICE to hold oral appeal hearing for Ferring’s Firmagon

18-06-2014

Privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals confirmed today that its drug…

Ferring PharmaceuticalsFirmagonOncologyPharmaceuticalRegulationUK

Colombia an attractive and fast-growing emerging pharma market

Colombia an attractive and fast-growing emerging pharma market

18-06-2014

The South American country Colombia has an attractive pharmaceutical market that should appeal to multinational…

ColombiaGenericsMarkets & MarketingPricingRegulationSouth America

UK’s NICE recommends Sucampo’s Amitiza for CIC

UK’s NICE recommends Sucampo’s Amitiza for CIC

18-06-2014

The UK health care watchdog the National Institute of Health and Care Excellence (NICE) has released…

AmitizaGastro-intestinalsPharmaceuticalPricingRegulationSucampoUK

Gardasil approved in Europe for the prevention of anal cancer

Gardasil approved in Europe for the prevention of anal cancer

18-06-2014

Sanofi Pasteur MSD says that the European Commission has granted marketing authorization for the use…

EuropeGardasilHPVOncologyPharmaceuticalRegulationSanofi Pasteur MSD

New NICE guidance on cardiovascular treatments

New NICE guidance on cardiovascular treatments

18-06-2014

Thousands of people with atrial fibrillation could be saved from strokes, disability or death because…

Cardio-vascularPharmaceuticalRegulationUKWarfarin Sodium

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

17-06-2014

USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration…

BiotechnologyOncologyRare diseasesRegulation

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

17-06-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGermanyInvokanaJanssen-CilagJohnson & JohnsonPharmaceuticalPricingRegulation

Australia’s TGA joins EDQM's CEP assessment process

Australia’s TGA joins EDQM's CEP assessment process

17-06-2014

The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the…

AustraliaEuropeGenericsRegulation

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