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EU Commission OKs Takeda’s acquisition of Nycomed


The European Commission said yesterday that it has cleared under the EU Merger Regulation the acquisition…

Mergers & AcquisitionsNycomedPharmaceuticalRegulationTakeda Pharmaceuticals

Laquinimod’s modest efficacy means it is no threat to Novartis’ Gilenya in MS, says Nomura


Commenting on the failure of Teva Pharmaceutical Industries’ (Nasdaq: TEVA) Phase III trial for…

GilenyalaquinimodNeurologicalNovartisPharmaceuticalRegulationTeva Pharmaceutical Industries

New US drug approvals in 2011 already match 2010 total


The July approval of AstraZeneca’s blood-thinner Brilinta (ticagrelor), a potential blockbuster…

BiotechnologyNorth AmericaPharmaceuticalRegulation

AstraZeneca gets EU approval for Axanum; Merck & Co files ridaforolimus with EMA


Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that it has received approval in…

Ariad PharmaceuticalsAstraZenecaAxanumCardio-vascularEuropeMerck & CoOncologyPharmaceuticalRegulationridaforolimus

Protalix submits CRL reply to FDA on Gaucher drug taliglucerase; reports new trial data


USA-based Protalix BioTherapeutics (NYSE-AMEX: PLX) says it has submitted its reply to the Complete Response…

North AmericaPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationtaliglucerase

US FDA backs SC form of B-MS Orencia; extends review of Pfizer’s Prevnar 13


The US Food and Drug Administration has approved a subcutaneous (SC) formulation of drug major Bristol-Myers…

Anti-Arthritics/RheumaticsBristol-Myers SquibbNorth AmericaOrenciaPfizerPharmaceuticalPrevnarRegulationVaccines

Eisai epilepsy drug delayed by US FDA, but Zonegran use extension filing accepted in EU


There was disappointment for Japanese drug major Eisai (TYO: 4523) last week when the US Food and Drug…

EisaiEuropeNeurologicalNorth AmericaperampanelPharmaceuticalRegulationZonegran

Amylin and Eli Lilly submit CRL reply on Bydureon to US FDA


US biotech Amylin Pharmaceuticals (Nasdaq: AMLN), drug major Eli Lilly (NYSE: LLY) and partner Alkermes…

AlkermesAmylinBiotechnologyBydureonDiabetesEli LillyNorth AmericaPharmaceuticalRegulation

UK’s NICE adds GlaxoSmithKline Trobalt as new NHS epilepsy option


UK pharma major GlaxoSmithKline’s Trobalt (retigabine) has been recommended for use in the UK’s…


Takeda refiles NDAs with US FDA for diabetes drug alogliptin and combo with pioglitazone


Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has resubmitted two New Drug…

ActosalogliptinDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

Valeant back on takeover path, now eyeing Sweden’s Meda: Canada OKs Sublinox


Unconfirmed press reports indicate that Canada’s Valeant Pharmaceutical International (NYSE: VRX)…

Markets & MarketingMedaNeurologicalNorth AmericaPharmaceuticalRegulationSublinoxValeant Pharmaceuticals

UK’s NICE backs use of TMC’s Angiox for STEMI patients undergoing primary PCI


Following a previous positive draft guidance, the UK drugs watch dog the National Institute for Health…

AngioxCardio-vascularEuropePharmaceuticalPricingRegulationThe Medicines Company

European Commission gives conditional OK for Biogen Idec’s MS drug Fampyra


The European subsidiary of US biotech firm Biogen Idec (Nasdaq: BIIB) has received conditional approval…

Acorda TherapeuticsAmpyraBiogen IdecEuropeFampyraNeurologicalPharmaceuticalRegulation

Watson Pharma confirms challenge of GlaxoSmithKline Jalyn patent


US generic drugs firm Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories,…

GenericsGlaxoSmithKlineJalynLegalNorth AmericaOncologyPatentsPharmaceuticalRegulationWatson Pharmaceuticals

Ranbaxy debuts generic Femara in UK, France and Romania; FDA OKs Zydus plant


India’s largest drugmaker, Ranbaxy Laboratories (RANB: BO) which is 64% owned by Japan’s Daiichi…

Asia-PacificEuropeFemaraGenericsMarkets & MarketingNovartisOncologyRanbaxy LaboratoriesRegulationZydus Cadila

US FDA unit CDER develops strategic science and research agenda


A US Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), made…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

European Medicines Agency updates drug package leaflets


The European Medicines Agency has updated the template for package leaflets for human medicines, to make…


US FDA now joins in probe of Sanofi’s Multaq safety


The US Food and Drug Administration says it is reviewing data from a clinical trial that was evaluating…

Cardio-vascularMultaqNorth AmericaPharmaceuticalRegulationSanofi

FDA advisory panel backs Janssen’s Remicade for pediatric use in ulcerative colitis


A US Food and Drug Administration advisory committee has recommended the approval of health care major…

Gastro-intestinalsJanssen PharmaceuticaJohnson & JohnsonNorth AmericaPharmaceuticalRegulationRemicade

UCB’s Vimpat syrup recalled in EU due to batch defect


The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has agreed to a…


European Medicines Agency updates on pioglitazone, Pandemrix and Champix


Yesterday saw a batch of recommendations from the European Medicines Agency’s advisory body, including…

ActosChampixDiabetesEuropeGlaxoSmithKlineNeurologicalPandemrixPfizerPharmaceuticalRegulationTakeda PharmaceuticalsVaccines

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