Clinical Intelligence

The CenterWatch Monthly, May 2016

Monday, May 2, 2016

Sites smothered by technology solutions

Technology solutions help sponsors and CROs make better drug develop­ment decisions, streamline processes and reduce clinical trial costs. But for a majority of investigative sites, these same technologies get in the way of efficient op­erations and add to their already heavy workload. CenterWatch analysis suggests that in­vestigative sites are inundated with a grow­ing number of technologies that rarely in­teract with each other. Only 9% of global investigative sites surveyed report that technology solutions provided by sponsors and CROs to conduct clinical studies meet their operating needs “very well.”


Welcoming procurement onto the team

For decades, procurement profession­als have been the Rodney Danger­fields of the pharmaceutical industry: they got no respect. Procurement held up projects, got bogged down in protracted budget and contract negotiations, and was a hassle. The function is now changing. Pro­curement is moving from the back room to front and center. Searching for new ways to improve the effectiveness of their collaborations with CROs and investigative sites, sponsor companies are looking at the procure­ment function as a more strategic rela­tionship-driving asset. The role of pro­curement professionals is evolving from one focused almost exclusively on cost-savings and transactional activities to one focused more strategically on facilitating collaboration, innovation and efficiency.

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Inovio, NIH, Mayo to initiate hepatitis C immunotherapy trial

Thursday, April 28, 2016

Inovio Pharmaceuticals has announced that its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies.

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Novartis granted three Breakthrough designations for Ilaris

Wednesday, April 27, 2016

The FDA has granted three Breakthrough Therapy designations for Novartis’ Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes, also known as Hereditary Periodic Fevers. Novartis will work closely with the FDA to expedite the regulatory review of Ilaris for these conditions.

Periodic Fever Syndromes are a group of autoinflammatory diseases that cause disabling and recurrent fevers, which may be accompanied by joint pain and swelling, muscle pain and skin rashes, with complications that can be life-threatening. Most patients present with symptoms in infancy or childhood.

The three conditions for which Ilaris is being reviewed are Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS) and Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and in Familial Mediterranean Fever (FMF) patients who are not adequately controlled with colchicine.

“This is an important day for patients, including many children, who are affected by these serious and debilitating syndromes that have no or limited treatment options,” said David Epstein, division head, Novartis Pharmaceuticals. “Ilaris is a promising medicine under review for these conditions, marking our commitment to making a significant difference to the lives of people with rare diseases.”

The FDA considers a treatment a Breakthrough Therapy if it is intended to treat a serious or life-threatening condition and preliminary evidence indicates it may be better than existing treatments. If approved, Ilaris will likely be the first medicine to gain approval from drug regulators for the treatment of TRAPS and HIDS/MKD, and it will be an alternative to the only FDA-approved treatment for FMF, colchicine.

The Breakthrough Therapy Designations were granted based on the pivotal phase III trial (Canakinumab Pivotal Umbrella Study in Three Hereditary Periodic Fevers). Based on this study, Novartis submitted three supplemental Biologic License Applications in the U.S. to register Ilaris for use in these indications.

Ilaris was approved by the FDA in 2009 to treat two subtypes of a rare autoinflammatory disease called Cryopyrin-Associated Periodic Syndromes (CAPS): Muckle-Wells syndrome (MWS) and Familial Cold Autoinflammatory Syndrome (FCAS), in patients aged four and older. In 2013, the FDA approved Ilaris for a rare, autoinflammatory form of juvenile idiopathic arthritis called Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged two and older.

Viveve announces positive topline results For VIVEVE I clinical trial

Tuesday, April 26, 2016

Viveve Medical, a company focused on women’s health, has announced positive top-line results from the VIVEVE I clinical study. The VIveve Treatment of the Vaginal Introitus to EValuate Efficacy study is the first randomized, single-blinded and sham-controlled trial designed to demonstrate the efficacy and safety of the Viveve Treatment versus a sham control procedure for the treatment of vaginal introital laxity.

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FDA accepts Lundbeck resubmission of NDA for Carnexiv (carbamazepine)

Monday, April 25, 2016

The FDA has accepted for review the resubmission of Lundbeck’s New Drug Application (NDA) for intravenous Carnexiv, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2016. Lundbeck’s resubmission was in reply to the Complete Response Letter from the FDA issued in 2014 requesting additional data associated with the Chemistry, Manufacturing and Controls (CMC) of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.

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