Herpes Zoster, also called shingles, is a painful skin rash caused by the varicella-zoster virus, the same virus that causes chickenpox. After a person recovers from chickenpox, the virus remains inactive in the body. Usually the virus does not cause any further problems; however, the virus may re-emerge years later, causing shingles.
Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and
Aestus Therapeutics, Inc. announced that it has been awarded a $2 million Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH). The grant, from the NIH's National Institute of Neurological Disorders and Stroke (NINDS), will fund clinical trials of Aestus's novel, first-in-class treatment for chronic neuropathic pain.
Depomed, Inc. today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
EpiCept Corporation today announced that the targeted enrollment in a Phase IIb trial for EpiCept NP-1 in chemotherapy-induced peripheral neuropathy has been attained. The trial is being conducted by National Cancer Institute -funded Community Clinical Oncology Program.
Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX tablets.
RegeneRx Biopharmaceuticals, Inc. announced today the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal.
Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.
Takeda Pharmaceutical Company Limited and its wholly owned subsidiary Millennium: The Takeda Oncology Company today announced that Takeda has entered into a co-promotion agreement with Janssen Pharmaceutical K.K. for VELCADE® (bortezomib) for Injection, a treatment for patients with multiple myeloma.
In the not too distant future, it may be possible to discern an individual's genetic predisposition to chronic pain conditions and treat them proactively to prevent lifetime afflictions, according to research presented today at the American Pain Society's (www.ampainsoc.org) annual scientific meeting.
Merck & Co., Inc. today announced financial results for the first quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the first quarter of $0.83, which excludes purchase accounting adjustments, merger-related expenses and restructuring costs, as well as a tax charge related to the recently enacted health care reform legislation. First-quarter GAAP EPS was $0.09.
Constantly rising U.S. health care costs could be reduced significantly by preventing and treating neuropathic pain conditions associated with diabetes and herpes zoster virus infections, according to research published in The Journal of Pain, the peer review publication of the American Pain Society, www.ampainsoc.org and jpain.org.
EMD Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that new data providing further understanding on Cladribine Tablets as a potential new therapeutic option for relapsing forms of multiple sclerosis were presented at the 62nd Annual Meeting of the American Academy of Neurology.
Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
Inhibitex, Inc. today announced its financial results for the fourth quarter and year ended December 31, 2009 and provided an update on various corporate developments.
Black children are less likely than white or Asian children to develop shingles (herpes zoster) after receiving the varicella vaccine to prevent chickenpox, reports a study in the March issue of The Pediatric Infectious Disease Journal.
Merck & Co., Inc. today announced financial results for the fourth quarter and the full year of 2009 which include the results of legacy Schering-Plough operations from the close of the merger on Nov. 3, 2009 through Dec. 31, 2009.
The Canadian Pain Society (CPS) supports the National Advisory Committee on Immunization (NACI) recommendations for the use of a vaccine to significantly reduce the risk of developing herpes zoster (shingles) and post herpetic neuralgia in adults over the age of 60 without contraindications.
EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.
Inhibitex, Inc. today announced that its collaborator, Pfizer, Inc., has initiated patient recruitment for 408-patient, randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in healthy adults.
Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).
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