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.
UCB is committed to providing the opportunity to patients to make informed decisions about participating in clinical trials.
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.
CTI BioPharma Corp. announced its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in the fourth quarter of 2015 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (trials, could potentially reduce time to market by up to 14 months.
Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on clinicaltrials.gov and on roche-trials.com 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.
Merck known as MSD outside the United States and Canada, today announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for the treatment of C. difficile. Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.