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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

Executive Q&A: Bob Radie, chief executive and president of Egalet

Executive Q&A: Bob Radie, chief executive and president of Egalet

11-04-2014

In an interview with The Pharma Letter, Egalet Corporation’s chief executive Bob Radie discusses the…

AnalgesiaChemistryChief executiveCombination productsEgalet CorpEgalet CorporationInterviewsPharmaceuticalSevere chronic painUSA

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

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

Study: Half of veterans prescribed medical opioids continue to use them chronically

Study: Half of veterans prescribed medical opioids continue to use them chronically

07-03-2014

A study of nearly 1 million veterans who receive opioids to treat painful conditions found that more…

AnalgesiaHealthcarePharmaceuticalResearchUSA

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

FDA says Durect’s pain relief drug Posidur needs additional safety studies

FDA says Durect’s pain relief drug Posidur needs additional safety studies

13-02-2014

US drugmaker Durect Corp says that the US Food and Drug Administration has issued a Complete Response…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

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

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

Actavis confirms challenge of Lilly’s Axiron patent

Actavis confirms challenge of Lilly’s Axiron patent

14-11-2013

US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US…

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

Majorelle to market Apricus’ ED product in France, Monaco and certain African countries

13-11-2013

USA-based Apricus Biosciences has signed an exclusive license agreement with Laboratoires Majorelle,…

Apricus BioscienceEuropeLaboratoires MajorelleLicensingMen's HealthPharmaceuticalRest of the WorldVitaros

Altus signs $4 million agreement with Zogenix to license Zohydro ER

04-11-2013

Altus Pharmaceuticals has entered into an agreement with Zogenix to develop abuse deterrent formulations…

AnalgesiaLicensingNorth AmericaPharmaceuticalZogenixZohydro

Orexo’s Zubsolv could take market share from Suboxone, report suggests

Orexo’s Zubsolv could take market share from Suboxone, report suggests

30-10-2013

Edison Equity Research analysts say that expected new clinical data from Swedish drug developer Orexo…

AnalgesiaFinancialMarkets & MarketingNorth AmericaOrexo ABPharmaceuticalReckitt BenckiserZubsolv

Zogenix shares leap after FDA approval for Zohydro ER

Zogenix shares leap after FDA approval for Zohydro ER

28-10-2013

Shares of Zogenix rocketed on Friday after the US Food and Drug Administration approved Zohydro ER extended-release…

AnalgesiaNorth AmericaPharmaceuticalRegulationZogenixZohydro

FDA calls for reclassification of codeine combo medications to stricter schedules

FDA calls for reclassification of codeine combo medications to stricter schedules

25-10-2013

The US Food and Drug Administration has indicated that it wants to see the classification of codeine-containing…

AnalgesiaHydrocodone Bitartrate and AcetaminophenNorth AmericaPharmaceuticalRegulation

Pfizer to continue Remoxy pain relief development

Pfizer to continue Remoxy pain relief development

24-10-2013

US pharma giant Pfizer will continue the development program for Remoxy Extended-Release Capsules CII,…

AnalgesiaNorth AmericaPfizerPharmaceuticalRemoxyResearch

Iroko’s pain relief drug effective at low doses

Iroko’s pain relief drug effective at low doses

22-10-2013

Iroko Pharmaceuticals has announced that the US Food and Drug Administration has approved Zorvolex capsules…

AnalgesiaIrokoNorth AmericaPharmaceuticalRegulationZorvolex

Mixed results for Pfizer’s two Lyrica Phase IIIb studies

Mixed results for Pfizer’s two Lyrica Phase IIIb studies

21-10-2013

Pfizer has announced mixed results from two Phase IIIb studies of Lyrica capsules CV in patients with…

AnalgesiaLyricaNorth AmericaPfizerPharmaceuticalResearch

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