Transparency trends, regulations push sponsor commitment to publish clinical trial results
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
Archives for October 26, 2017
Single-source outsourcing model saves pharma sponsors $45m, Tufts report
Sponsors using a single-source outsourcing partner could potentially save up to $45m through reduced time to market, according to a recent Tufts study.
French CRO Kyomed emphasizes human and societal aspects of new health tech
Kyomed will evaluate the use of a connected bracelet to diagnose sleep apnea through a “holistic approach” the CRO hopes will become a benchmark for the future – and has been nominated for a MedStartup award.
Lonza maintains 2017 target and says US plant and Capsugel integration on track
Lonza has reaffirmed its full-year sales and earnings forecast and updated about its US operations and the integration of Capsugel.
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US FDA rejects Translarna and says additional trial and CMC data is needed
The US FDA has rejected the muscular dystrophy candidate Translarna (ataluren), telling PTC Therapeutics more trial data is needed to prove the drug works and asking for additional information about how it is made.
SPC waiver will ‘level the playing field’ for European API makers
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.