investigational product

investigational product

A test article or pharmaceutical form of an active ingredient or placebo that is tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, used for an unapproved indication, or used to gain further information about an approved use.
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United States-based Zogenix has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational product, ZX008 (low-dose fenfluramine) intended for the treatment of seizures associated with Dravet syndrome, it was reported yesterday.
Alkermes unveiled Aripiprazole Lauroxil NanoCrystal Dispersion, a novel, investigational product designed for initiation onto Aristada xtended-release injectable suspension for the treatment of schizophrenia.
AcelRx Pharmaceuticals, Inc, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, reported key results from the Phase 3 IAP312 study of ZALVISO (sufentanil sublingual tablet system), an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting.
In addition, it must ensure that each investigational product has the same appearance, even in transparent syringe barrels.
Zogenix's lead investigational product candidate, Zohydro ER (hydrocodone bitartrate extended release capsules), is an oral, extended-release formulation of various strengths of hydrocodone, without acetaminophen, intended for administration every 12 hours for around the clock management of moderate to severe chronic pain.
70 a share, subject to certain milestones related to Omtheraa[euro](tm)s investigational product Epanova or global net sales being achieved, the buyer said.
Cambridge, MA, announced the FDA has conditionally approved its Investigational Device Exemption (IDE) to evaluate its ViaCyte investigational product offering for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology.
But a "no-fault" system applies in Austria, Denmark, Finland, France, Italy, the Netherlands, Portugal, Spain, Sweden and the United Kingdom, under which an injured subject receives financial compensation for any serious impairment induced by an investigational product or procedure used in a clinical trial.
NASDAQ: TOCA) has released updated data demonstrating long-term durable responses, and the conversion of initial partial responses (PRs) into complete responses (CRs), from a Phase 1 study of Tocagen's investigational product, Toca 511, followed by Toca FC, for the treatment of patients with recurrent high-grade glioma (HGG), the company said.
Biopharmaceutical company GW Pharmaceuticals plc (NasdaqGM:GWPH) reported on Wednesday the receipt of approval in the EU for its investigational product Epidiolex for the treatment of Lennox-Gastaut Syndrome (LGS), a treatment-resistant, debilitating childhood-onset epilepsy.
s (NASDAQ: CAPR) HOPE-1 clinical trial of its lead investigational product, CAP-1002, in boys and young men in advanced stages of Duchenne muscular dystrophy, the company said.

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