Regulation - Pharmaceutical, Biotechnology

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US drug approvals lower than previously reported; new study

10-01-2014

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

23-11-2013

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

27-10-2013

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

16-10-2013

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

04-10-2013

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

ArzerraBiotechnologyEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

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

18-09-2013

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

18-09-2013

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

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofi

Genzyme's MS drug Lemtrada approved in Europe

17-09-2013

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

AubagioBiotechnologyEuropeGenzymeLemtradaNeurologicalPharmaceuticalRegulationSanofi

Positive developments for GSK's Tafinlar/Mekinist and Arzerra

16-09-2013

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

13-09-2013

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

02-09-2013

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

BiotechnologyEuropeHerceptinOncologyPharmaceuticalRegulationRoche

Sanofi's MS drug Aubagio gains final European approval

02-09-2013

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

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalRegulationSanofi

German pharma watch dog finds benefits for biologicals in RA

30-08-2013

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

30-08-2013

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

27-08-2013

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

27-08-2013

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

20-08-2013

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

Asia-PacificBayerBiotechnologyOncologyPharmaceuticalRegulationStivarga

Cancer and orphan drugs drive increase in US NME approvals

08-08-2013

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

08-08-2013

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

08-08-2013

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

07-08-2013

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

06-08-2013

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

BiotechnologyEuropeOncologyPerjetaPharmaceuticalPricingRegulationRoche

Aegerion gains European approval for rare disease drug

05-08-2013

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

02-08-2013

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

BiotechnologyEuropeJetreaOphthalmicsPharmaceuticalPricingRegulationThromboGenics

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