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Nanobiotix starts clinical trial with lead product for soft tissue sarcoma


Nanobiotix, an emerging French nanomedicine company focused on cancer therapy, says that its lead compound,…


One-third of changes to clinical trial protocols are avoidable, says Tufts CSDD


Nearly 60% of all protocols used in clinical trials for new drugs are amended during the trial. Moreover,…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

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…


Long-term outlook and predictability key to successful medicines policy for Australia, conference told


A predictable regulatory and reimbursement environment, and a long-term policy outlook are essential…


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

Final rule on medical researchers’ financial ties is disappointing on transparency, says US Sen Grassley


Earlier this week, the US federal government is releasing the final version of long-awaited transparency…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulationResearch

US govt tightens financial conflict of interest rules for medical researchers


The US Department of Health and Human Services this week issued an updated Final Rule on conflict of…

FinancialNorth AmericaPharmaceuticalRegulationResearch

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

Growing global regulatory requirements challenge drug developers, says Tufts CSDD


As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct…


US payers will want more info on biosimilars than FDA may accept for approval, survey finds


To feel comfortable with biosimilars, US payers survey by advisory firm Decision Resources indicate they…

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