Regulation - Pharmaceutical, Licensing


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FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review


The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

Arena Pharma in deal with Teva unit for marketing Belviq in Israel


USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its…

AbicArena PharmaceuticalsBelviqLicensingMetabolicsObesityPharmaceuticalRegulationRest of the WorldTeva Pharmaceutical Industries

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix


Japanese drug major Eisai has exercised its option to jointly develop and commercialize its clinical…

Biogen IdecEisaiFycompaGermanyItalyLicensingNeurologicalPharmaceuticalPricingRegulationZebinix

Allergan closes $65 million deal with Medytox

Allergan closes $65 million deal with Medytox


This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement…


moksha8 files Viibryd and Colobreathe in Brazil; amends Forest alliance


Brazil-based pharma firm moksha8 has filed applications with the Brazilian regulatory authority, ANVISA,…

BrazilColoBreatheForest LaboratoriesLicensingMerck SeronoMoksha8NeurologicalPharmaceuticalRare diseasesRegulationSouth AmericaViibryd

Takeda to commercialize Teva’s glatiramer acetate for MS in Japan

Takeda to commercialize Teva’s glatiramer acetate for MS in Japan


Revealing an earlier agreement yesterday, Israel’s Teva Pharmaceutical Industries and Japan’s largest…

Asia-PacificCopaxoneGlatiramer AcetateLicensingNeurologicalPharmaceuticalRegulationTakeda PharmaceuticalsTeva Pharmaceutical Industries

Kyorin expects $10 million sales after Flutiform launch in Japan for asthma

Kyorin expects $10 million sales after Flutiform launch in Japan for asthma


UK drug delivery specialist Skyepharma (LSE: SKP) has announced that Flutiform has been launched in Japan…

Asia-PacificFlutiformKyorin PharmaceuticalsLicensingPharmaceuticalRegulationRespiratory and PulmonarySkyepharma

Bioniche’s Canadian filing for Urocidin delayed


Canadian biopharma firm Bioniche Life Sciences has provided an update on its plans for a New Drug Submission…

Bioniche Life SciencesLicensingPharmaceuticalRegulationResearchUrocidin

Cardiome gains European MA rights for Brinavess from Merck & Co


Canada-based Cardiome Pharma (TSX: COM) has announced adoption of the decision by the European Commission…

BrinavessCardio-vascularCardiome PharmaEuropeLicensingMerck & CoPharmaceuticalRegulation

RedHill Biopharma views regulatory pathway for RHB-101 in CHF and hypertension


Emerging Israeli biopharma company RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive…

BiotechnologyCardio-vascularCarvedilolLicensingPharmaceuticalRedHill BiopharmaRegulationResearchRHB-101

Bristol-Myers gets added indication from US FDA for Sustiva; signs second deal with Ambrx


US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved…

AmbrxAnti-viralsBiotechnologyBristol-Myers SquibbCardio-vascularDiabetesLicensingNorth AmericaPharmaceuticalRegulationSustiva

Briefs: Roche deal with Chiasma; Vasella payout; FDA priority review for dolutegravir


Swiss drug major Roche (ROG: SIX) has entered into an agreement to develop and commercialize privately…

Anti-viralsdolutegravirGlaxoSmithKlineLicensingManagementNovartisOctreotide AcetatePharmaceuticalRare diseasesRegulationRocheViiV Healthcare

Roche affiliate Chugai files for T-DM1 approval in Japan; gains rights to Afraxis compound


Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority owned by Swiss major Roche (ROG:…

AfraxisAsia-PacificChugai PharmaceuticalGenentechGlobalLicensingOncologyPharmaceuticalProductionRegulationRocheT-DM1trastuzumab emtansine

SOBI gains EMA approval for change of Kineret producer; Novartis drops NIC002 project


Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Medicines Agency for the…

BiotechnologyBoehringer IngelheimCytos BiotechnologyKineretLicensingNIC002NovartisPharmaceuticalProductionRegulationSwedish Orphan Biovitrum

AstraZeneca's Brilinta gains Class I in ACCF/AHA Guidelines; enters deal with Progenics


Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced yesterday that a combined panel of experts…

Antibiotics and Infectious diseasesAstraZenecaBrilintaCardio-vascularLicensingMedImmunePharmaceuticalProgenics PharmaceuticalsRegulation

Isis Pharma/GlaxoSmithKline's ISIS-TTR Rx gains US fast-track designation


In what has been a busy newsflow few days for USA-based Isis Pharmaceutical (Nasdaq: ISIS), the company…

BiotechnologyGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesRegulation

News briefs from Bayer, AstraZeneca and Valeant/Galderma


German drug major Bayer (BAYN: DE) and partner Regeneron (Nasdaq: REGN) submitted a marketing application…

AstraZenecaBayerEuropeEyleaFaslodexGaldermaLicensingNorth AmericaOncologyOphthalmicsPerlanePharmaceuticalRegulationRestylaneValeant Pharmaceuticals

VentiRx collaborates with Celgene on cancer drug candidate; pomalidomide update


VentiRx Pharmaceuticals, a privately held US biopharmaceutical company dedicated to the development of…

BiotechnologyCelgeneLicensingNorth AmericaOncologyPharmaceuticalpomalidomideRegulationVentiRx PharmaceuticalsVTX-2337

Research news: dolutegravir; TD-1211; and synaptic modulators


UK pharma giant GlaxoSmithKline (LSE: GSK) and Japanese drugmaker Shionogi (TYO: 4507) have reported…

Anti-viralsdolutegravirGalenea CorpGastro-intestinalsGlaxoSmithKlineLicensingNeurologicalPharmaceuticalRegulationResearchShionogiTD-1211TheravanceZonegran

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