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2201 to 2225 of 2250 results

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

05-09-2011

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

05-09-2011

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

BiotechnologyEuropePharmaceuticalRegulationResearch

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

04-09-2011

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

BiotechnologyDendreonFinancialPharmaceuticalProvenge

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

04-09-2011

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

01-09-2011

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

BiotechnologyFinancialOncologyOphthalmicsResearchZybrestat

PCMA outlines $100 billion in Rx drug savings in USA

01-09-2011

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

01-09-2011

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

BiotechnologyFinancialVivalis

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

30-08-2011

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

26-08-2011

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

Asia-PacificBiotechnologyFinancialPharmaceuticalResearch

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

26-08-2011

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

25-08-2011

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

24-08-2011

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

23-08-2011

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

22-08-2011

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

22-08-2011

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

21-08-2011

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

BiotechnologyEuropePharmaceuticalRegulation

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

18-08-2011

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

16-08-2011

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

Anti-viralsBiotechnologyGilead SciencesPharmaceuticalResearch

Pharming extends Ruconest deal with SOBI

16-08-2011

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

15-08-2011

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

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

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