Regulation - Pharmaceutical, Biotechnology


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US drug approvals lower than previously reported; new study


The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan


There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Positive EMA/CHMP opinions for Actelion and Lundbeck

Positive EMA/CHMP opinions for Actelion and Lundbeck


At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products…

ActelionBiotechnologyBrintellixEuropeLundbeckNeurologicalOpsumitPharmaceuticalRegulationRespiratory and Pulmonary

Janssen-Cilag files European approval of combination medicine for HIV-1


US health care giant Johnson & Johnson subsidiary Janssen-Cilag International NV has submitted a Marketing…

Anti-viralsBiotechnologycobicistatDarunavirEuropeGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulation

GSK and Genmab file for Arzerra variation in Europe


GlaxoSmithKline ) and partner Genmab have submitted a variation to the Marketing Authorization to the…


Lyxumia's delayed entrance into US anti-diabetes drug market could prove successful in the future, says GlobalData's analyst


French drug major Sanofi's (Euronext: SAN) decision to withdraw Lyxumia's (lixisenatide)...

BiotechnologyCardio-vascularDiabetesLyxumiaNorth AmericaPharmaceuticalRegulationResearchSanofi

UK's NICE calls for more information on MS treatment Aubagio


UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme,…


Genzyme's MS drug Lemtrada approved in Europe


French drug major Sanofi (Euronext: SAN) and its USA-based biotech subsidiary Genzyme revealed this morning…


Positive developments for GSK's Tafinlar/Mekinist and Arzerra


UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs,…

ArzerraBiotechnologyGenmabGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

FDA advisory panel backs new indication for Genentech's Perjeta


The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) yesterday (September…

BiotechnologyGenentechKadcylaNorth AmericaOncologyPerjetaPharmaceuticalRegulationRoche

Roche's new timesaving formulation of Herceptin approved in Europe


Swiss pharma major Roche (ROG: SIX) revealed this morning (September 2) that a new injectable (subcutaneous)…


Sanofi's MS drug Aubagio gains final European approval


Following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products…


German pharma watch dog finds benefits for biologicals in RA


The German Institute for Quality and Efficiency in Health Care (IQWiG) examined nine biotechnologically…

Anti-Arthritics/RheumaticsBiotechnologyCimziaEnbrelEuropeHumiraKineretMabTheraOrenciaPharmaceuticalPricingRegulationRemicadeRoActemraSimponi Injection

FDA acceptance of ibrutinib NDA triggers milestone for Pharmacyclics


California, USA-based Pharmacyclics (Nasdaq: PCYC) said yesterday (August 29, 2013) that the US Food…

BiotechnologyibrutinibJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

Health Canada backs pediatric Humira for Crohn's


US drugmaker AbbVie (NYSE: ABBV) says that Health Canada has approved its blockbuster rheumatoid arthritis…

AbbVieBiotechnologyGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

Nexavar gains FDA priority review for thyroid cancer sNDA


German drug major Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX), which has just agreed…

BayerBiotechnologyNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Bayer gets Japanese OK for GI stromal tumors drug


German drug major Bayer (BAYN: DE) has received approval from the Ministry of Health, Labor and Welfare…


Cancer and orphan drugs drive increase in US NME approvals


Until 2010, the number of New Molecular Entities (NMEs) approved by the US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulation

AHF claims victory over FDA in HIV prevention drug case


The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

Orexigen updates on obesity drug filing plans


US biopharma company Orexigen Therapeutics (Nasdaq: OREX) yesterday (August 7) announced its plan to…

BiotechnologyContraveEuropeFinancialMetabolicsOrexigen TherapeuticsPharmaceuticalRegulation

New Zealand to widen access for type 1 and type 3 Gaucher disease drug


New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval of a proposal to widen…

Asia-PacificBiotechnologyCerezymeGenzymePharmaceuticalRare diseasesRegulationSanofi

UK NICE guidance says breast cancer drug Perjeta not value for money


The UK's National Health Service (NHS) is to be advised that it should not routinely provide Swiss drug…


Aegerion gains European approval for rare disease drug


The European Commission has approved US biopharma company Aegerion Pharmaceuticals' (Nasdaq: AEGR) Lojuxta…

Aegerion PharmaceuticalsBiotechnologyCardio-vascularEuropeJuxtapidKynamroLojuxtalomitapidePharmaceuticalRare diseasesRegulation

Germany's IQWiG confirms Jetrea's added value for VMT patients


Belgian biopharma company ThromboGenics (Euronext Brussels: THR) announced today (August 2) that the…


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