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Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

Ampio’s Vyrix unit out-licenses certain rights for Zertane to Paladin

10-04-2014

USA-based biotech firm Ampio Pharmaceuticals says its wholly-owned subsidiary Vyrix Pharmaceuticals…

Ampio PharmaceuticalsBiotechnologyEndo Health SolutionsLicensingMen's HealthPaladin LabsVyrix PharmaceuticalsZertane

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Medigene signs collaboration with Falk Pharma for RhuDex

Medigene signs collaboration with Falk Pharma for RhuDex

19-03-2014

German biotechnology company Medigene has signed an exclusive global license agreement with drugmaker…

BiotechnologyDr Falk PharmaGastro-intestinalsGermanyLicensingMedigeneNephrology and Hepatology

Pfizer tackles Torrent over generic Viagra

Pfizer tackles Torrent over generic Viagra

19-03-2014

US pharma giant Pfizer is taking legal action against Indian drugmaker Torrent Pharmaceuticals to stop…

GenericsIndiaLegalMen's HealthPfizerPharmaceuticalTorrent PharmaceuticalsUSAViagra

Executive Q&A: Fibrotech's chief executive Darren Kelly

Executive Q&A: Fibrotech's chief executive Darren Kelly

18-03-2014

The Pharma Letter interviewed chief executive Darren Kelly about Fibrotech’s ethos and its lead product,…

AustraliaBiotechnologyFibrotechInterviewsNephrology and Hepatology

Strong Ph III data on Intercept’s OCA, but shares hit by side effect concerns

Strong Ph III data on Intercept’s OCA, but shares hit by side effect concerns

17-03-2014

USA-based Intercept Pharmaceuticals reported positive Phase III results on its obeticholic acid (OCA)…

Intercept PharmaceuticalsNephrology and Hepatologyobeticholic acidPharmaceuticalResearch

Islet Sciences to acquire BHV Pharma along with diabetes and NASH products

Islet Sciences to acquire BHV Pharma along with diabetes and NASH products

13-03-2014

US biotech firm Islet Sciences says it has signed a binding letter of intent to acquire Brighthaven Ventures…

BiotechnologyDiabetesIslet SciencesMergers & AcquisitionsNephrology and Hepatologyremogliflozin

La Jolla’s shares soar as it reports positive results in kidney disease trial

12-03-2014

US-based La Jolla Pharmaceutical Company has announced positive top-line results from its randomized,…

La Jolla PharmaceuticalNephrology and HepatologyPharmaceuticalResearchUSA

Keryx Biopharma files for EU approval of Zerenex

Keryx Biopharma files for EU approval of Zerenex

10-03-2014

US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European…

EuropeKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationZerenex

Endo’s testosterone replacement Aveed gets FDA approval

Endo’s testosterone replacement Aveed gets FDA approval

06-03-2014

Endo International says its operating company Endo Pharmaceuticals has received US Food and Drug Administration…

AveedEndo PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationUSA

Ardelyx licenses NaP2b to Sanofi in deal worth up to $198 million

Ardelyx licenses NaP2b to Sanofi in deal worth up to $198 million

25-02-2014

US venture-funded biopharmaceutical company Ardelyx has licensed its novel phosphate transport NaP2b…

ArdelyxAstraZenecaLicensingNaP2bNephrology and HepatologyPharmaceuticalSanofitenapanor

Recordati gains certain rights to Apricus’ Vitaros

10-02-2014

Italian drugmaker Recordati has signed an exclusive license agreement with the USA’s Apricus Biosciences…

Apricus BioscienceEastern EuropeLicensingMen's HealthPharmaceuticalRecordatiRest of the WorldTurkeyVitaros

FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products

03-02-2014

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

Chronic kidney disease drug market forecast to reach $11.7 billion in 2022

Chronic kidney disease drug market forecast to reach $11.7 billion in 2022

29-01-2014

After an initial decline driven by generic and biosimilar competition in the G7 (USA, Japan, France,…

AbbVieAmgenAstellas PharmaAstraZenecaGlobalKyowa Hakko KirinMarkets & MarketingNephrology and HepatologyPharmaceuticalRegpararoxadustatSensiparvelcalcetide

FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

Intercept rockets on positive liver disease drug trial

10-01-2014

Shares of USA-based Intercept Pharmaceuticals tripled to $275.87 by close of trading on January 9, when…

Dainippon Sumitomo PharmaIntercept PharmaceuticalsNephrology and Hepatologyobeticholic acidPharmaceuticalResearch

Italy’s Gentium accepts $1 billion takeover offer from Jazz Pharma

20-12-2013

Ireland-headquartered drugmaker Jazz Pharmaceuticals has entered into a definitive agreement to acquire…

defibrotideDefitelioGentiumItalyJazz PharmaceuticalsMergers & AcquisitionsNephrology and HepatologyPharmaceuticalRare diseases

Ampio Pharma takes spin-out route on failure to find Zertane partner

Ampio Pharma takes spin-out route on failure to find Zertane partner

16-12-2013

US drug developer Ampio Pharmaceuticals announced that it has spun off its sexual dysfunction business…

Ampio PharmaceuticalsAmpionInflammatory diseasesMen's HealthMergers & AcquisitionsPharmaceuticalProductionVyrix PharmaceuticalsZertane

Apricus expands Vitaros deal with Novartis unit

Apricus expands Vitaros deal with Novartis unit

16-12-2013

USA-based Apricus Biosciences has expanded its exclusive license agreement with Hexal AG, an affiliate…

Apricus BioscienceEuropeLicensingMen's HealthNovartisPharmaceuticalSandozVitaros

Sanofi to commercialize Vivus ED drug in Africa, Middle East, Turkey and CIS/Russia

Sanofi to commercialize Vivus ED drug in Africa, Middle East, Turkey and CIS/Russia

12-12-2013

US drugmaker Vivus has entered into a license and commercialization agreement with French pharma major…

avanafilEastern EuropeLicensingMarkets & MarketingMen's HealthPharmaceuticalRest of the WorldSanofiVivus

Increase in awareness of hypogonadism will drive testosterone replacement therapy market

11-12-2013

The testosterone replacement therapy (TRT) market has been forecast to reach a value of $5.1 billion…

GlobalMarkets & MarketingMen's HealthPharmaceutical

US FDA approves first drug treatment for Peyronie’s disease

US FDA approves first drug treatment for Peyronie’s disease

07-12-2013

The US Food and Drug Administration has approved a new use for US company Auxilium Pharmaceuticals Xiaflex…

Auxilium PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationXiaflex

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