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Arzerra and ospemifene NDAs submitted in Japan

02-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish company Genmab A/S (OMX: GEN) have submitted a…

ArzerraAsia-PacificGenmabGlaxoSmithKlineOncologyospemifenePharmaceuticalQuatRx PharmaRegulationShionogiWomen's Health

Ukraine to introduce reference pricing and plans for prescription system

01-05-2012

The Ukraine Ministry of Health and domestic producers of pharmaceuticals have signed a memorandum of…

EuropeGenericsHealthcarePharmaceuticalPricingRegulation

US FDA delays Salix' Crofelemer approval

01-05-2012

US drugmaker Salix Pharmaceuticals (Nasdaq: SLXP) revealed yesterday that the Food and Drug Administration…

crofelemerGastro-intestinalsNorth AmericaPharmaceuticalRegulationSalix Pharmaceuticals

Access to low-price generics threatened by technologies due to be used in EU

30-04-2012

Producers of generic medicines are raising concerns on the huge cost implications of possible new anti-falsification…

EuropeGenericsRegulation

Biopharmaceuticals "no longer a growth market" in Germany

30-04-2012

After years of consistent growth, the German biopharmaceuticals market came to a juddering halt last…

BiotechnologyEuropeMarkets & MarketingPharmaceuticalPoliticsPricingRegulation

US FDA clears new ED drug Stendra

30-04-2012

The US Food and Drug Administration late Friday gave its approval for drug developer Vivus (Nasdaq: VVUS)…

avanafilMen's HealthNorth AmericaPharmaceuticalRegulationReproductiveStendraVivus

FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases

30-04-2012

USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

US FDA backs new indications for Votrient and Afinitor

29-04-2012

The US Food and Drug Administration last week gave its approval for new indications for currently marketed…

AfinitorGlaxoSmithKlineNorth AmericaNovartisOncologyPharmaceuticalRegulationVotrient

US FDA again delays action on Takeda's alogliptin diabetes drug

26-04-2012

Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response…

ActosalogliptinDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

First Cushing's drug, Novartis' Signifor, approved in the EU

25-04-2012

The European Commission has approved Swiss drug major Novartis' (NOVN: VX) Signifor (pasireotide) for…

EuropeNovartisOncologyPharmaceuticalRare diseasesRegulationSignifor

FDA extends review of Ironwood and Forest's linaclotide to September

24-04-2012

The US Food and Drug Administration has told USA-based drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD)…

Forest LaboratoriesGastro-intestinalsIronwood PharmaceuticalslinaclotideNorth AmericaPharmaceuticalRegulation

Canada's drug review process needs enhancements, says diabetes charity

24-04-2012

According to a new report by the charity the Canadian Diabetes Association, despite improvements to Canada's…

North AmericaPharmaceuticalRegulation

FDA strengthens monitoring of post-approval drug safety

23-04-2012

In what is seen as a response to criticism that the agency lacks teeth in monitoring drugs once they…

BiotechnologyMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal

23-04-2012

Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Crucial need for global development of biosimilars, says head of European generics group

20-04-2012

"The need for a framework which allows global biosimilars development is now crucial," argued European…

BiotechnologyGenericsGlobalRegulation

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