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FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

Pozen re-files for US approval of PA8140/PA32540

Pozen re-files for US approval of PA8140/PA32540

02-07-2014

US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole)…

AspirinCardio-vascularOmeprazolePA8140/PA32540PharmaceuticalPozenRegulationUSA

US FDA outlines expectations for human drug compounders

US FDA outlines expectations for human drug compounders

02-07-2014

Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug…

PharmaceuticalRegulationUSA

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

02-07-2014

Belgium-based biopharma firm ThromboGenics has said that Jetrea (ocriplasmin) has been approved in Uruguay…

JetreaOphthalmicsPharmaceuticalRegulationThromboGenicsUruguay

Medicines Australia submits new transparency reforms to ACCC

Medicines Australia submits new transparency reforms to ACCC

02-07-2014

Trade body Medicines Australia has applied for authorization of the 18th Edition of its Code of Conduct…

AustraliaPharmaceuticalRegulation

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Ipsen files sNDA for Somatuline for GEP-NETs

Ipsen files sNDA for Somatuline for GEP-NETs

01-07-2014

French drugmaker Ipsen has submitted a Supplemental New Drug Application to the US Food and Drug Administration…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

01-07-2014

Drug delivery specialists pSivida says that the regulatory process for marketing authorizations of Iluvien…

EuropeIluvienOphthalmicsPharmaceuticalpSividaRegulation

EMA accepts Merck’s pembrolizumab MAA for review

EMA accepts Merck’s pembrolizumab MAA for review

01-07-2014

US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing…

EuropeMerck & CoOncologypembrolizumabPharmaceuticalRegulation

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

30-06-2014

US pharma giant GlaxoSmithKline and US partner Theravance have submitted a supplemental New Drug Application…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUSA

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

FDA approves MannKind’s Afrezza to treat diabetes

FDA approves MannKind’s Afrezza to treat diabetes

30-06-2014

In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s…

AfrezzaDiabetesMannKindPharmaceuticalRegulationUSA

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

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