Pain management company Scintilla Pharmaceuticals has announced it will acquire SCILEX Pharmaceuticals to bolster its pain management business. SCILEX is engaged in the development and commercialization of products focused on the treatment of pain. Its lead product candidate, ZTlido, is a branded lidocaine patch formulation being developed for the treatment of postherpetic neuralgia, the chronic pain that sometimes develops with shingles.
Seth Lederman, M.D. has worked with many patients with fibromyalgia as a physician, and knows they have waited long enough for relief from its symptoms. “Those symptoms can quickly take over their lives,” he says. “Fibromyalgia is considered to be a pain disorder but it’s much more than that.”
By now you have heard about the tragic clinical trial in France that has resulted in the death of one person and the hospitalization of four others. While full details of what caused the fatal death of a healthy man are still not available, we do know the trial was likely testing an FAAH-inhibitor. Maia Szalavitz, writing on the website Vice.com, says this should be a wakeup call to some legal substance users in the U.S.
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
The regulatory landscape for the development and approval of analgesic products has a well-documented history in the literature and the regulatory annals for these extremely important therapeutic compounds. Current products range from the frequently administered non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of acute pain, osteoarthritis and other sensory/nociceptive pain to the controlled opioids, Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors (SSRIs/SNRIs), and gamma-Aminobutyric acid (GABA) analogues that relieve pain of a more chronic and neuropathic nature. By David Shoemaker, Senior Vice President, Research and Development, Rho
The process of discovering and bringing a drug to market consists of several stages, beginning with identification and validation of a drug target and continuing through lead identification by high-throughput screening, lead optimization, and profiling in relevant disease models.
ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.
The biomarker menus include a sampling of our most frequently requested markers of efficacy, exposure, response and susceptibility.
This paper describes the application of the PHT LogPad® to studies in the therapeutic area of pain. It is intended as a summary educational document for readers familiar with clinical trials.
ePharmaSolutions, a global study launch and site support services company, developed and deployed a highly effective patient recruitment campaign that yielded an outstanding number of qualified referrals to support an osteoarthritis of the knee study in patients that were currently on a medication regimen.
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This week Cellular Biomedicine Group (OTCQB: CBMG) held a ceremony to mark the launch of their clinical trial for haMPC (Human Adipose-derived Mesenchymal Progenitor Cells) therapy for Knee Osteoarthritis (KOA).
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOARx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis.
Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.
Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
Anacor Pharmaceuticals today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
CeQur SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that initial data from a study of the company's PaQ® Insulin Delivery Device were presented today at the 6th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-CRPRx in patients with paroxysmal atrial fibrillation.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Adynxx, Inc. announced today that they have entered into an option agreement under which Cubist has the exclusive right to acquire Adynxx following the data readout of Adynxx’s Phase 2 trial for its lead product candidate, AYX1.
Adynxx, a clinical-stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced recently that the first patient was dosed in a Phase 2 study of its lead investigational drug candidate for the prevention of post-surgical pain, AYX1.
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
