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EU Commission OKs Takeda’s acquisition of Nycomed

03-08-2011

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

02-08-2011

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

02-08-2011

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

02-08-2011

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

02-08-2011

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

01-08-2011

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

01-08-2011

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

29-07-2011

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

29-07-2011

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

EuropeGlaxoSmithKlineNeurologicalPharmaceuticalRegulationTrobalt

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

27-07-2011

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

27-07-2011

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

27-07-2011

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

26-07-2011

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

26-07-2011

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

26-07-2011

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

26-07-2011

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

25-07-2011

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

EuropePharmaceuticalRegulation

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

25-07-2011

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

25-07-2011

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

25-07-2011

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

EuropeNeurologicalPharmaceuticalRegulationUCBVimpat

European Medicines Agency updates on pioglitazone, Pandemrix and Champix

22-07-2011

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

ActosChampixDiabetesEuropeGlaxoSmithKlineNeurologicalPandemrixPfizerPharmaceuticalRegulationTakeda PharmaceuticalsVaccines

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