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US Pharma now developing 44 drugs/vaccines for HIV/AIDS

11-09-2014

The USA’s biopharmaceutical research companies are currently developing 44 medicines and vaccines for…

Anti-viralsPharmaceuticalResearchUSAVaccines

New indication for Astellas/Medivation’s Xtandi from US FDA

New indication for Astellas/Medivation’s Xtandi from US FDA

11-09-2014

The US Food and Drug Administration has approved a new indication for the use of Japanese drug major…

Astellas PharmaMedivationOncologyPharmaceuticalResearchUSAXtandi

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

10-09-2014

Ireland-based generic drug major Actavis yesterday confirmed that the US Food and Drug Administration's…

ActavisCardio-vascularnebivololPharmaceuticalRegulationUSAvalsartan

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

09-09-2014

The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s…

Anti-diabetic drugsDiabetesliraglutideNovo NordiskPharmaceuticalRegulationTreatment of obesityUSA

Bristol-Myers Squibb and Ono Pharma sue Merck over Keytruda

Bristol-Myers Squibb and Ono Pharma sue Merck over Keytruda

08-09-2014

US drug major Bristol-Myers Squibb and partner Japan’s Ono Pharmaceutical have filed a law suit against…

Advanced melanomaBristol-Myers SquibbIpilimumabKeytrudaLaw suitLegalMerck & CoOncologyOno PharmaceuticalPharmaceuticalUSA

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

Keryx' shares fall as FDA approves kidney drug, but with warnings

Keryx' shares fall as FDA approves kidney drug, but with warnings

07-09-2014

US drugmaker Keryx Biopharmaceuticals has received approval from the US Food and Drug Administration…

ferric citrateKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenvelaSanofiUSAZerenex

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

07-09-2014

US specialty drugmaker Depomed says that Judge Kentaji Brown Jackson of the federal district court for…

DepomedGraliseLegalNeurologicalPharmaceuticalRare diseasesUSA

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

Ablynx launches American Depository Receipt program to expand US investor base

Ablynx launches American Depository Receipt program to expand US investor base

05-09-2014

Belgian drug developer Ablynx has launched a Sponsored Level I American Depository Receipt (ADR) program…

AblynxBusiness FinanceFinancialInvestmentPharmaceuticalStock marketUSA

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

FDA accepts Actavis NDA for eluxadoline

FDA accepts Actavis NDA for eluxadoline

03-09-2014

Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted…

ActaviseluxadolineForest LaboratoriesFuriex PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

Lundbeck launches Northera in USA

Lundbeck launches Northera in USA

02-09-2014

Danish CNS specialist Lundbeck said today that Northera (droxidopa) capsules for oral use are now available…

Chelsea TherapeuticsLundbeckMarkets & MarketingNeurologicalNortheraPharmaceuticalUSA

Ipsen receives priority review for sNDA for Somatuline

Ipsen receives priority review for sNDA for Somatuline

01-09-2014

French drugmaker Ipsen has received priority review for its supplemental New Drug Application from the…

Gastroenteropancreatic neuroendocrine tumorsIpsenOncologyPharmaceuticalRegulationSomatulineUS Food and Drug AdministrationUSA

FDA backs added use for UCB’s Vimpat

01-09-2014

Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a…

NeurologicalPharmaceuticalRegulationUCBUSAVimpat

Takeda and Lilly fail to overturn $9 billion award for hiding cancer risk of Actos

Takeda and Lilly fail to overturn $9 billion award for hiding cancer risk of Actos

31-08-2014

Japan’s largest drugmaker Takeda Pharmaceutical and US pharma major Eli Lilly have failed in their…

ActosDiabetesEli LillyFinancialLegalPharmaceuticalTakeda PharmaceuticalUSA

FTC puts conditions on acquisition of Insight Pharma by Prestige Brands

29-08-2014

US firm Prestige Brands Holdings, the maker of Dramamine (dimenhydrinate), has agreed to divest assets…

Insight PharmaceuticalsMergers & AcquisitionsPharmaceuticalPrestige BrandsRegulationUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

Colorectal cancer market will remain steady at $7.7 billion by 2023; report

29-08-2014

The market for colorectal cancer (CRC) therapies will remain constant, at around $7.7 billion by 2023…

EuropeJapanMarkets & MarketingOncologyPharmaceuticalUSA

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