The Astellas Group (*1) (hereinafter collectively “Astellas”) recognises that making clinical trial information and results more widely available to researchers, healthcare professionals, patients, and interested members of the public will benefit public health. Therefore, Astellas is committed to publicly sharing data on clinical trials that are being performed under its responsibility. To meet this commitment, Astellas will comply with relevant laws, regulatory requirements and industry guidance for registration of clinical trial information and disclosure of clinical trial results.

AstraZeneca today announced the creation of a Scientific Review Board that will act independently to assess requests from external researchers which include patient level data. The Board of independent clinicians and academics has been established as part of AstraZeneca’s commitment to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) Responsible Data Sharing Principles, as well as the new European Medicines Agency Clinical Trial Policy and Regulation.

Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on and on since 2005. Alongside this posting, we actively seek presentation and publication of our clinical trial data at scientific congresses and in peer-reviewed journals.

Valeant Pharmaceuticals International, Inc.’s  wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for VESNEO™ (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension. If approved, VESNEO will be the first nitric oxide donating prostaglandin receptor agonist available for the above indication.

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