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Roche to file for trastuzumab emtansine this year, on positive Ph III results

03-04-2012

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III…

BiotechnologyGenentechGlaxoSmithKlineOncologyPharmaceuticalRegulationResearchRochetrastuzumab

FDA OKs pregnancy use of Novo Nordisk diabetes therapy Levemir

02-04-2012

The US Food and Drug Administration has approved Levemir (insulin detemir [rDNA origin] injection), from…

DiabetesLevemirNorth AmericaNovo NordiskPharmaceuticalRegulation

Poland breaking EU law by allowing unauthorized cheaper drugs

02-04-2012

Polish legislation authorizing the placing on the market of foreign medicinal products lacking authorization…

EuropeGenericsLegalMarkets & MarketingPharmaceuticalRegulation

German IQWiG finds mixed added benefits for Eliquis

02-04-2012

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalPricingRegulation

Genzyme and Isis file Kynamro NDA in USA

02-04-2012

Biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), has submitted a New Drug…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

BIO supports sufficient appropriations for FDA on BsUFA and PDUFA; backed by GPhA

01-04-2012

The Biotechnology Industry Organization (BIO) has expressed its support for funding of the Food and Drug…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

NICE recommendations on Bayer's Xarelto and Amgen Xgeva's for UK NHS use

30-03-2012

Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY:…

AmgenBayerCardio-vascularEuropeOncologyPharmaceuticalPricingRegulationXareltoXgeva

FDA calls for more data from Chelsea Thera on Northera

30-03-2012

The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application…

BiotechnologyChelsea TherapeuticsNeurologicalNorth AmericaNortheraRegulation

Bipartisan Bill to strengthen testing of pediatric drugs launched in USA

29-03-2012

US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulationResearch

Medicines registration harmonization program for East Africa launches

29-03-2012

The NEPAD Agency, on behalf of the African Medicines Regulatory Harmonization (AMRH) Program partners…

PharmaceuticalRegulationRest of the World

Botox shows efficacy in idiopathic overactive bladder, says Allergan

29-03-2012

USA-based Allergan (NYSE: AGN) announced that two Phase III clinical trials of Botox (onabotulinumtoxinA),…

AllerganBotoxGenito-urinaryPharmaceuticalRegulationResearch

QRxPharma value assed as Actavis deal finalized

29-03-2012

Australian company QRxPharma (ASX: QRX) is moving rapidly towards the commercial phase for its lead product,…

ActavisFinancialLicensingNeurologicalPharmaceuticalQRxPharmaRegulation

FDA delay for MAP Pharma migraine drug candidate

28-03-2012

Shares of USA-based MAP Pharmaceuticals (Nasdaq: MAPP) plunged 24% to $13.01 in early trading yesterday,…

AllerganLevadexMAP PharmaceuticalsMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulation

Astellas files for EU approval of EC905, EMA accepts avanafil filing

28-03-2012

The European subsidiary of Japanese drug major Astellas Pharma (Tokyo: 4503) has announced the submission…

Astellas PharmaavanafilEuropeMen's HealthPharmaceuticalRegulationVivus

EMA and HMA agree common approach on commercially confidential info and personal data

27-03-2012

Following recent meetings, the Heads of Medicines Agencies and the European Medicines Agency yesterday…

BiotechnologyEuropePharmaceuticalRegulationResearch

Consumer groups call for condemnation of ACTA independent of ECJ

27-03-2012

Health-related consumer groups Health Action International (HAI) Europe, Oxfam, Medecins Sans Frontieres…

EuropeGenericsGlobalLegalPatentsPharmaceuticalPoliticsRegulation

European governments must ensure R&D is converted into new businesses, new products

27-03-2012

National governments in Europe need to do more to ensure that R&D innovation in the biotech industry…

BiotechnologyEuropeFinancialRegulationResearch

Recalls threaten public confidence in vaccines and immunoglobulins

27-03-2012

Quality defects and donor tissue history must be more carefully monitored to increase public acceptance…

BiotechnologyHealthcareImmunologicalsRegulationVaccines

Arena Pharma updates on lorcaserin filings in EU and USA

27-03-2012

San Diego, USA-based Arena Pharmaceuticals (Nasdaq: ARNA) revealed yesterday that the European Medicines…

Arena PharmaceuticalsEisaiEuropelorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulation

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