Regulation - Bridion


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Changing of the Guard begins in biotech sector


The biotechnology sector is bracing for change this year as a flurry of "biosimilar" or "biogeneric"…

BiotechnologyGenericsMarkets & MarketingNorth AmericaRegulation

Russia should boost innovation to drive economic growth, says OECD


Russia should increase protection of intellectual property, strengthen competition and invest more in…


FDA accepts ciclesonide NDA from Nycomed partner Sunovion


Swiss drugmaker Nycomed, the subject of a $13.7 billion takeover bid from Japan’s Takeda (TYO:4502;…

Ciclesonide Inhalation AerosolNorth AmericaNycomedPharmaceuticalRegulationRespiratory and PulmonarySunovion

Blow for Orexigen as regulatory demands see firm put obesity drug Contrave on hold


Shares of US biotech firm Orexigen Therapeutics (Nasdaq: OREX) plunged 33% to $2.13 by afternoon trading…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

Good news for RVO suffers as EU approves Novartis’ Lucentis and NICE backs Allergan’s Ozurdex


The European Commission has granted Novartis a new indication for Swiss drug major Novartis’ (NOVN:…


UK Pharma group ABPI has qualms about GMC proposal


Responding to the UK General Medical Council (GMC) consultation on “Good practice in prescribing…


US FDA says use of ARBs for hypertension does not increase risk of cancer


The US Food and Drug Administration stated yesterday that a group of drugs used to control high blood…

Cardio-vascularNorth AmericaPharmaceuticalRegulation

CROMA and B&L’s eye drug Yellox approved by the European Commission


Austria-based CROMA Pharma GmbH, a private global specialty pharmaceutical and surgical company, and…

Bausch & LombCROMA PharmaEuropeOphthalmicsPharmaceuticalRegulationYellox

Pfizer files for EU approval of axitinib in advanced kidney cancer


The European Medicines Agency (EMA) has accepted US drugs behemoth Pfizer’s (NYSE: PFE) filing for…


European Medicines Agency and HMA propose measures on dossier transparency


A guidance document on the identification of commercially confidential information and protection of…


Tianyin granted production license for diabetes drug Gliclazide by China's SFDA


Tianyin Pharmaceutical (NYSE Amex: TPI), a China-based pharmaceutical company that specializes in patented…

Asia-PacificDiabetesGliclazidePharmaceuticalRegulationTianyin Pharma

European Commission to lift suspension of Octapharma MA for Octagam


The European Commission has adopted the European Medicines Agency’s recommendation 2011 to lift…

EuropeOctagamOctapharmaPharmaceuticalRare diseasesRegulation

CBO Director reviews potential effects of a ban on DTC advertising of new Rx drugs in USA


Direct-to-consumer (DTC) advertising of prescription drugs in the USA has elicited various concerns,…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

Changing the Indian culture in reporting adverse drug reactions


Adverse drug reactions (ADRs) are the sixth global leading cause of death among hospitalized patients…

Asia-PacificBoehringer IngelheimPharmaceuticalRegulationResearch

Recommendations for European Medicines Agency communication on medicines; 40 years of PIC/S


A report written by an independent expert has highlighted a number of recommendations to help improve…


MAP Pharma files NDA with US regulator for Levadex in migraine


MAP Pharmaceuticals (Nasdaq: MAPP) has submitted a New Drug Application to the US Food and Drug Administration…

LevadexMAP PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulation

New legislation to fight against falsified medicines adopted by EU


The European Union Council on Friday formally adopted new legislation aimed at protecting patients against…


Chiesi, Eli Lilly and Bayer named for breaches of the ABPI Code of Practice


The UK subsidiaries of Italy’s Chiesi, US drug major Eli Lilly (NYSE: LLY) and Germany’s Bayer…

BayerChiesi FarmaceuticiEli LillyEuropeLevitraNeurologicalPharmaceuticalRegulationReproductiveYasmin

US GPhA calls on House Appropriations Committee to protect funding for FDA; welcomes Solicitor General’s action


The USA’s Generic Pharmaceutical Association (GPhA) has written to House Appropriations Committee…

FinancialGenericsLegalNorth AmericaRegulation

2368 to 2392 of 2450 results

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