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GlaxoSmithKline and Theravance file for Japanese approval of Anoro Ellipta


UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) today April 22) announced…

Anoro ElliptaAsia-PacificGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

Merck & Co opens new $120 million manufacturing plant in China


US Pharma giant Merck & Co (NYSE: MRK) has opened its new pharmaceutical manufacturing facility in Hangzhou,…

Asia-PacificCardio-vascularDiabetesFinancialMerck & CoPharmaceuticalProductionRespiratory and Pulmonary

FDA advisory panel backs approval of COPD drug Breo Ellipta


Having earlier this week been presented with ambivalent briefing papers, the US Food and Drug Administration's…

Breo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

Positive Ph III results for Almirall and Forest's combination COPD drug


Spain's largest pharma company Almirall (ALM: MC) and USA-based partner Forest Laboratories (NYSE:FRX)…

AlmirallBretaris GenuairEklira GenuairForest LaboratoriesPharmaceuticalResearchRespiratory and Pulmonary

USA FDA seeks clarification on Discovery Labs' Surfaxin; issues briefing papers on GSK's Breo Ellipta


US biotech firm Discovery Laboratories (Nasdaq: DSCO) says that the Food and Drug Administration has…

Breo ElliptaDiscovery LaboratoriesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxinTheravance

Ares Life Sciences to make second 2013 acquisition, the USA's Antigen Laboratories


Ares Life Sciences has signed a definitive agreement to acquire 100% of the share capital of privately-held…

Antigen LaboratoriesAres Life SciencesMergers & AcquisitionsPharmaceuticalPlanet BiopharmaceuticalsRespiratory and Pulmonary

Bayer's PAH drug candidate riociguat gets US priority review; Sativex rescheduled in UK


The US Food and Drug Administration has granted priority review to German drug major Bayer's (BAYN: DE)…

BayerEuropeGW PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryriociguatSativex

Regulatory updates for Tris Pharma's Karbinal; GSK's four-strain seasonal flu vaccine


US drug delivery specialist Tris Pharma says that the US Food and Drug Administration has approved its…

Anti-viralsEuropeFluarixGlaxoSmithKlineInflusplit TetraKarbinalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTris Pharma

US FDA accepts Merck & Co's BLA for Timothy grass pollen allergy product


US pharma giant Merck & Co (NYSE: MRK) says that its Biologics License Application for the investigational…

ALK AbelloGrazaxImmunologicalsMerck & CoPharmaceuticalRegulationRespiratory and Pulmonary

FDA approves Novartis' TOBI Podhaler and Cangene's first Botulism Antitoxin heptavalent


The US Food and Drug Administration on Friday approved Swiss drug major Novartis' (NOVN: VX) TOBI Podhaler…

Antibiotics and Infectious diseasesBotulism antitoxinCangeneNorth AmericaNovartisPharmaceuticalRegulationRespiratory and PulmonaryTobi Podhaler

Positive NICE news for GSK's Revolade and InterMune's Esbriet


UK drugs watchdog the National Institute for Health and Clinical Excellence today (March 21) issued two…

BiotechnologyEsbrietEuropeGlaxoSmithKlineImmunologicalsInterMunePharmaceuticalPricingRegulationRespiratory and PulmonaryRevolade

US FDA calls for new trial with Pharmaxis' CF drug Bronchitol


Australian pharma company Pharmaxis (ASX: PXS) says it has received a complete response letter from the…

BronchitolNorth AmericaPharmaceuticalPharmaxisRare diseasesRegulationRespiratory and Pulmonary

Roche pulls out of fibrosis alliance with Galapagos


Belgium-based Galapagos (Euronext Brussels: GLPG) revealed that Swiss drug major Roche (ROG: SIX) has…

GalapagosLicensingPharmaceuticalRespiratory and PulmonaryRoche

Ares Life Sciences to acquire Albion Medical and its GREER Laboratories unit


Ares Life Sciences says it has signed a definitive agreement to acquire 100% of the share capital of…

Albion MedicalAres Life SciencesGREER LaboratoriesImmunologicalsMergers & AcquisitionsOralairPharmaceuticalRespiratory and PulmonaryStallergenes

NICE makes U-turn, recommending Novartis' Xolair for children aged six-11 years


UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 7)…

EuropeNovartisPharmaceuticalPricingRegulationRespiratory and PulmonaryXolair

Genentech Ph III study of omalizumab shows promise in CIU


Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase…

BiotechnologyDermatologicalsGenentechNovartisOmalizumabPharmaceuticalRegulationResearchRespiratory and PulmonaryRocheXolair

Boehringer Ingelheim presents positive efficacy data for tiotropium in asthma patients


German family-owned drug major Boehringer Ingelheim presented a new subset of data from the Phase III…

Boehringer IngelheimPharmaceuticalResearchRespiratory and PulmonarySpirivatiotropium

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval


US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

FDA advisory panel backs Boehringer's COPD drug olodaterol


In a 15 to one vote with one abstension, the US Food and Drug Administration's Pulmonary-Allergy Drugs…

Boehringer IngelheimNorth AmericaolodaterolPharmaceuticalRegulationRespiratory and PulmonaryStriverdi Respimat

New Zealand approves funding of sildenafil for Raynaud's phenomenon and bosentan for children with PAH


New Zealand's Pharmaceutical Management Agency PHARMAC has approved proposals for funding Pfizer's (NYSE:…

ActelionAsia-PacificBiotechnologybosentanFinancialPfizerPharmaceuticalRegulationRespiratory and PulmonaryRevatiosildenafilTracleer

Sweden's Orexo in respiratory research accord with AstraZeneca


Swedish drug developer Orexo AB (STO: ORX) has entered into an agreement with Anglo-Swedish drug major…

AstraZenecaLicensingOrexo ABOX-CLIPharmaceuticalResearchRespiratory and Pulmonary

GlaxoSmithKline and Theravance file for EU approval of UMEC/VI for COPD


UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) yesterday submitted…

AnoroBiotechnologyEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUMEC/VIumeclidiniumvilanterol

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