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US pharma and FDA near agreement on PDUFA reauthorization, with 6% hike in user fees


After many months of negotiations with the Food and Drug Administration, the USA’s pharmaceutical…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

EFPIA supports full transparency of clinical data, but with reservations


The European Medicines Agency has carried out a consultation on increased transparency and access to…


Volatile markets in August take a toll on US life sciences IPOs, says Burrill


Market volatility in August battered life sciences companies that went public this year, wiping away…


Japan’s Toyobo to increase capacity for injectables, eyeing biosimilars


Japanese conglomerate Toyobo (TYOO: 3101) has outlined plans for its biosciences segment, which includes…

Asia-PacificBiotechnologyFinancialMarkets & MarketingPharmaceuticalToyobo

OXiGENE says Zybrestat Ph III study not feasible; cuts workforce as part of restructuring


California, USA biotech OXiGENE (Nasdaq: OXGN), a clinical-stage, company developing novel therapeutics…


PCMA outlines $100 billion in Rx drug savings in USA


As the USA’s Joint Select Committee on Deficit Reduction examines options to reduce the deficit…

BiotechnologyGenericsHealthcareNorth AmericaPharmaceuticalPricingRegulation

Strong first-half 2011 for Vivalis, with net loss nearly halved


French biotech firm Vivalis (Euronext Paris: VLS) has released its audited consolidated results for the…


US and European physicians wary of using biosimilars without clinical data backing


The majority of US and European physicians are wary of using a biosimilar for an indication for which…

BiotechnologyEuropeGenericsMarkets & MarketingNorth AmericaResearch

New R&D tax credit to boost Australian research


After more than two years of uncertainty over the fate of Australia’s new R&D Tax Credit, the relevant…


United Thera’s oral PAH drug treprostinil fails in Ph III study


US biotech firm United Therapeutics (Nasdaq: UTHR) says that preliminary results from its FREEDOM-C(2)…

BiotechnologyRegulationResearchRespiratory and PulmonaryTreprostinilUnited Therapeutics

Shire drops Dermagraft for venous leg ulcers, after Ph III failure


Ireland-headquartered drugmaker Shire (LSE: SHP) says that Advanced BioHealing (ABH), the USA-based regenerative…

Advanced BioHealingBiotechnologyDermagraftDermatologicalsPharmaceuticalRegulationResearchShire

CEL-SCI in deal to market Multikine in Argentina and Venezuela


US drug developer CEL-SCI Corp (NYSE AMEX: CVM) has entered into an exclusive sales, marketing and distribution…

BiotechnologyCEL-SCI CorpIDC-GP PharmLicensingOncologyPharmaceuticalSouth America

GlaxoSmithKline gets 25% stake in spin-out firm Autifony


UK pharma giant GlaxoSmithKline (LSE: GSK) has invested £1.25 million ($2.1 million) to receive a…

Autifony TherapeuticsBiotechnologyFinancialGlaxoSmithKlineMergers & Acquisitions

Orphan drug exclusion from US drug tax stand to harm innovation on rare diseases


The US Internal Revenue Services' issuance of temporary and proposed regulations implementing the annual…

BiotechnologyFinancialNorth AmericaPharmaceuticalRare diseases

IMS debuts MIDAS Biosimilars, a new market tool for fast-developing pharma segment


IMS Health has launched IMS MIDAS Biosimilars, a market measurement tool that enables clients to assess…

BiotechnologyGenericsGlobalMarkets & Marketing

New validation criteria for electronic submissions from Sept 1, 2011, says EMA


In a web site posting, the European Medicines Agency is informing pharmaceutical companies that a new…


US FDA delays decision on Regeneron’s wet AMD drug Eylea


US biotech firm Regeneron Pharmaceuticals. (Nasdaq: REGN) says that it has received notification from…

BayerBiotechnologyEyleaNorth AmericaOphthalmicsRegeneronRegulation

Gilead’s investigational Quad HIV regimen meets primary endpoint in Pivotal Ph III study


US biotech Gilead Sciences (Nasdaq: GILD) yesterday announced positive results from a Phase III clinical…

Anti-viralsBiotechnologyGilead SciencesPharmaceuticalResearch

Pharming extends Ruconest deal with SOBI


Netherlands-based biotech firm Pharming Group NV (Euronext: PHARM) has extended its existing agreement…

BiotechnologyEuropeLicensingPharmaceuticalPharmingRare diseasesRest of the WorldRhucinRuconestSwedish Orphan Biovitrum

US FDA signs deal to advance regulatory science with Arkansas state


An agreement to establish a virtual Center of Excellence for Regulatory Science was signed last week…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

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