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2390 to 2414 of 2628 results

Growing global regulatory requirements challenge drug developers, says Tufts CSDD

09-08-2011

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct…

BiotechnologyGlobalPharmaceuticalRegulationResearch

Allergan’s Botox gets positive European opinion for urinary incontinence

09-08-2011

US specialty drug firm Allergan (NYSE: AGN) has received a positive opinion from the Irish Medicines…

AllerganBotoxEuropeGastro-intestinalsPharmaceuticalRegulation

US payers will want more info on biosimilars than FDA may accept for approval, survey finds

08-08-2011

To feel comfortable with biosimilars, US payers survey by advisory firm Decision Resources indicate they…

BiotechnologyGenericsNorth AmericaRegulationResearch

UK’s NICE turns down Novartis MS drug Gilenya in draft guidance

07-08-2011

In provisional draft guidance published last Friday, UK drugs watchdog the National Institute for Health…

EuropeGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

Hospira gains US approval of solution version of gemcitabine injection

07-08-2011

US generic injectable drug leader Hospira (NYSE: HSP) says the US Food and Drug Administration has approved…

Eli Lillygemcitabine HclGemzarGenericsHospiraNorth AmericaOncologyRegulation

EU approves Boehringer’s Pradaxa for stroke prevention in atrial fibrillation

05-08-2011

There was good news for independent German drug major Boehringer Ingelheim yesterday, when the company…

BayerBoehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulationXarelto

Roche gets EU approval for RoActemra for children with rare form of arthritis

04-08-2011

The European Commission has approved the use of Swiss drug major Roche’s (ROG: SIX) RoActemra (tocilizumab)…

Anti-Arthritics/RheumaticsEuropePharmaceuticalRegulationRoActemraRoche

US FDA grants priority review as it accepts Incyte ruxolitinib NDA for myelofibrosis

04-08-2011

The US Food and Drug Administration has accepted for filing the New Drug Application (NDA) for drug developer…

IncyteNorth AmericaNovartisOncologyPharmaceuticalRegulationruxolitinib

Teva gains EU approval for oral contraceptive Zoely

04-08-2011

There was good news for the world’s largest generics drugmaker Teva Pharmaceutical Industries (Nasdaq:…

EuropeGenericsPharmaceuticalRegulationReproductiveTeva Pharmaceutical IndustriesTheramexZoely

MAP Pharma gets $20 million milestone as US FDA accepts Levadex NDA

03-08-2011

California, USA-based MAP Pharmaceuticals (Nasdaq: MAPP) says that its New Drug Application for Levadex…

AllerganLevadexMAP PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulation

Novartis appeals UK NICE negative decision on Lucentis in DME

03-08-2011

The UK subsidiary of Swiss drug major Novartis (NOVN: VX) has lodged an appeal against the decision last…

EuropeLucentisNovartisOphthalmicsPharmaceuticalPricingRegulation

EMA, FDA and international counterparts complete successful inspection pilots

03-08-2011

Two pilot programs of collaboration on inspections between the European Medicines Agency, the US Food…

GenericsGlobalPharmaceuticalRegulation

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

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

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

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

2390 to 2414 of 2628 results

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