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2251 to 2275 of 2581 results

Added benefit of Eisai’s Halaven not proven, says Germany’s IQWiG

17-02-2012

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

EisaiEuropeHalavenOncologyPharmaceuticalPricingRegulation

UK NICE asks for more data on Tarceva, and Botox for migraine

17-02-2012

UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) today issued new draft…

AllerganBotoxEuropeNeurologicalOncologyPharmaceuticalPricingRegulationRocheTarceva

GlaxoSmithKline files for Tykerb/Tyverb with trastuzumab in USA and Europe

17-02-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday that it has submitted regulatory applications…

EuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationtrastuzumabTykerbTyverb

GSK and Novartis withdraw EU extended use applications for Tyverb and Fluad, respectively

16-02-2012

The European Medicines Agency has been formally notified by UK pharma giant GlaxoSmithKline (LSE: GSK)…

EuropeFluadGlaxoSmithKlineNovartisOncologyPharmaceuticalRegulationTyverbVaccines

Quintiles expands in MENA pharma markets

16-02-2012

Biopharmaceutical services company Quintiles is extending its global footprint to provide commercial…

Dayarn PharmaMarkets & MarketingPharmaceuticalQuintilesRegulationRest of the World

Counterfeit Avastin found in USA by FDA

16-02-2012

The US Food and Drug Administration said yesterday that it is warning health care professionals and patients…

AvastinGenentechMarkets & MarketingNorth AmericaOncologyPharmaceuticalRegulationRoche

FDA now accepts Pfizer’s tafamidis NDA

16-02-2012

Having around a year ago issued a refuse to file letter (The Pharma Letter April 5, 2011), the US Food…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Karo Bio drops eprotirome and split up plans

15-02-2012

There was a double-dose of bad news for Sweden’s Karo Bio (STO: KARO), which this week said it would…

BiotechnologyCardio-vasculareprotiromeKaro BioMergers & AcquisitionsPharmaceuticalRegulation

US FDA priority review for Truvada for reducing HIV risk

15-02-2012

The US Food and Drug Administration has accepted the supplemental New Drug Application and granted a…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

PhRMA slams US President’s fiscal year 2013 budget plan

15-02-2012

Responding to US President Barack Obama’s fiscal year 2013 budget proposals, Pharmaceutical Research…

FinancialNorth AmericaPharmaceuticalPoliticsRegulation

Germany’s IQWiG finds no added benefit for Pfizer’s Xiapex

14-02-2012

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

EuropeInflammatory diseasesPfizerPharmaceuticalRegulationXiapex

FDA approves Merck & Co’s Zioptan

14-02-2012

The US Food and Drug Administration) has approved drug giant Merck & Co’s (NYSE: MRK) Zioptan (tafluprost…

Merck & CoNorth AmericaOphthalmicsPharmaceuticalRegulationSaflutanSanten PharmaceuticalsZioptan

Bayer’s Xarelto gets backing in Scotland

14-02-2012

German drug major Bayer’s (BAY: DE) oral anticoagulant Xarelto (rivaroxaban) has been accepted by…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

Rush Bill would make most patent settlement deals in USA unlawful

14-02-2012

Last week, US Representative Bobby Rush (Democrat, Illinois) introduced HR 3995, the Protecting Consumer…

GenericsLegalNorth AmericaPharmaceuticalRegulation

NICE views breast cancer drugs from GSK and Roche too expensive

14-02-2012

The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft…

EuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRegulationRocheTyverb

Columbia Labs hands over NDA to Watson

13-02-2012

Columbia Laboratories (Nasdaq: CBRX) has transferred the New Drug Application for progesterone vaginal…

Columbia LaboratoriesCrinoneLicensingNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

FDA wants more info on Menveo; advisory negative on Dacogen

13-02-2012

Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter…

Astex PharmaceuticalsDacogenEisaiMenveoNorth AmericaNovartisOncologyPharmaceuticalRegulationVaccines

Watson confirms patent challenge to Bayer’s Beyaz

13-02-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson…

BayerBeyazGenericsNorth AmericaPatentsRegulationReproductiveWatson Pharmaceuticals

Fitch backs FDA planned guidelines, saying they open the door to biosimilars

12-02-2012

Fitch Ratings believes the US Federal Drug and Administration's proposed biosimilar pathway regulations,…

BiotechnologyGenericsHospiraNorth AmericaRegulation

Clinical market in CIS to exceed $940 million euros in 2014

12-02-2012

Clinical trials in the Commonwealth of Independent States (CIS) countries have been developing in a positive…

EuropeMarkets & MarketingPharmaceuticalRegulationResearch

EMA guidelines on pharmacogenetics in evaluating pharmacokinetics of medicines

12-02-2012

The European Medicines Agency on Friday published a guideline advising pharmaceutical companies how to…

BiotechnologyEuropePharmaceuticalRegulationResearch

At last, draft guidance on biosimilars pathway from US FDA

10-02-2012

Coming somewhat behind European Union action, the US Food and Drug Administration late yesterday issued…

BiotechnologyGenericsNorth AmericaRegulation

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