The pain-reliever acetaminophen (also known as paracetomol) is one of the best-selling over-the-counter medications, used by more than 200 million Americans a year. It is sold under many brand names, including Tylenol, and is an ingredient in nearly 200 medications, both over-the-counter (such as Excedrin, Midol, NyQuil, and Sudafed) and prescription (such as Vicodin).
Labopharm Inc. today announced that it has completed the previously announced transaction to establish a joint venture with Gruppo Angelini.
Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.
Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.
Scientists at the University of Pittsburgh School of Medicine went on a molecular fishing trip and netted a catch of new mediators that not only can explain how omega-3 fatty acids reduce inflammation, but also hint at novel treatments for a host of diseases linked to inflammatory processes. Their findings were published today in the online version of Nature Chemical Biology.
Labopharm Inc. today reported its financial results for the first quarter 2010.
Cadence Pharmaceuticals, Inc. announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, for the treatment of pain and fever in adults and children.
Despite their widespread use by parents and caregivers, over-the-counter (OTC) cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.
Despite their widespread use by parents and caregivers, over-the-counter cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.
The majority of teens say they have never heard of acetaminophen - or what the appropriate dosing of it is even with access to the label instructions - despite having taken the medication recently, according to a new University of Rochester Medical Center Study assessing teens' health literacy. More than 60 percent of the teens in the study had never before heard of acetaminophen despite 21 percent of them having taken it within the previous month.
NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that that it has entered into a $40 million royalty financing agreement with Cowen Healthcare Royalty Partners, L.P. ("Cowen Royalty").
Labopharm Inc. and Gruppo Angelini today announced they have entered into an agreement to establish a joint venture in the United States for the commercialization of OLEPTRO, a novel once-daily formulation of the antidepressant trazodone approved by the U.S. Food and Drug Administration on February 3, 2010.
Cataldo Doria, M.D., Ph.D., Nicoletti Family Professor of Transplant Surgery at Jefferson Medical College of Thomas Jefferson University, and director of the Division of Transplantation at Thomas Jefferson University Hospital is the first transplant surgeon in the United States to use a new totally artificial liver assist device as a bridge to transplantation.
Cumberland Pharmaceuticals Inc. today announced that results from a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, will be presented at the 2010 Digestive Disease Week meeting in New Orleans.
Bayer Diabetes Care today announced the introduction of the DIDGET™ blood glucose monitoring system in the United States. The DIDGET meter is unique because it is the only blood glucose meter that connects directly to Nintendo DS™ and DS Lite gaming systems to help kids manage a lifelong disease by rewarding them for building consistent testing habits and meeting personalized blood glucose target ranges. Bayer's DIDGET meter is now available for purchase in the U.S. through CVS.com, Drugstore.com and Walgreens.com.
NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that Anthony DiTonno, President and CEO, and members of the NeurogesX management team, will host an Investor Day on Friday, April 30, 2010, from 8:15am-11:00am EDT in New York City
Labopharm Inc. today introduced INTELLITAB(TM), the brand name for its proprietary abuse and misuse-deterrent technology platform. The INTELLITAB(TM) platform, which can deliver one or more therapeutic drugs in combination over periods of up to 24 hours, has the potential to provide a patient with a controlled release medication while minimizing the risk of intentional abuse or accidental misuse.
Cadence Pharmaceuticals, Inc. announced today that, based on feedback received during a meeting with the U.S. Food and Drug Administration on April 16, 2010, it plans to re-submit a New Drug Application for its investigational product candidate, OFIRMEV (acetaminophen) injection, within the next 30 days.
Patients need help to navigate the health care system and to better manage their own chronic health conditions. New health care delivery models that effectively provide those services have been shown to both lower overall costs and improve patient health.
Cumberland Pharmaceuticals Inc. today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.
Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today announced that it has completed patient enrollment in a Phase 1 clinical trial evaluating the intravenous (IV) administration of JX-594, the company's lead product for the treatment of solid tumors. Jennerex expects to report the results from this trial at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in May 2010.