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Health Highlights: May 25, 2013
Posted today in Daily MedNews
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: 'Nanoparticle' Flu Vaccine Could Be an Advance Scientists have used nanotechnology to create a flu vaccine that may be quicker to develop and more adaptable to changing flu seasons. "This is, I believe, an important advance," Dr. Tony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases,...
Read more...Seniors More Likely to Crash When Driving With Pet: Study
Posted today in Daily MedNews
SATURDAY, May 25 -- Animals make great companions for senior citizens, but elderly people who always drive with a pet in the car are far more likely to crash than those who never drive with a pet, researchers have found. The new study included 2,000 licensed drivers aged 70 and older. The nearly 700 participants who had pets were asked how often they drove with their pet in the car. Among those who always drove with...
Read more...Hidden Dangers Dog Dog Parks
Posted today in Daily MedNews
SATURDAY, May 25 -- Many viruses and parasites that affect both dogs and humans, such as rabies and leptospirosis -- a bacteria-borne illness than can result in liver or kidney failure -- may be lurking at dog parks, according to a veterinarian. These germs could be found in the soil, water and even the air, said Dr. Susan Nelson, a clinical associate professor at Kansas State University's Veterinary Health Center....
Read more...Monday Best Time for Hospitalization With Heart Failure, Study Says
Posted yesterday in Daily MedNews
FRIDAY, May 24 -- Patients hospitalized for heart failure appear to have better odds of survival if they're admitted on Mondays or in the morning, a new study finds. Death rates and length of stay are highest among heart failure patients admitted in January, on Fridays and overnight, according to the researchers, who are scheduled to present their findings Saturday in Portugal at the annual meeting of the Heart...
Read more...Common Supplement May Help Patients Fight Heart Failure
Posted yesterday in Daily MedNews
FRIDAY, May 24 -- Regular doses of the dietary supplement Coenzyme Q10 cut in half the death rate of patients suffering from advanced heart failure, in a randomized double-blind trial. Researchers also reported a significant decrease in the number of hospitalizations for heart failure patients being treated with Coenzyme Q10 (CoQ10). About 14 percent of patients taking the supplement suffered from a major...
Read more...Merck Statement on FDA Advisory Committee Meeting for Suvorexant
Posted 3 days ago in New Drug Applications
WHITEHOUSE STATION, N.J., May 22, 2013 -- Merck, known as MSD outside the United States and Canada, today provided the following statement after the conclusion of the Peripheral and Central Nervous System Drugs Advisory Committee meeting of the U.S. Food and Drug Administration (FDA) about suvorexant, Merck’s investigational medicine to treat insomnia. “We are excited about the potential of suvorexant as a...
Read more...FDA Approves Xofigo for Advanced Prostate Cancer
Posted 1 weeks ago in New Drug Approvals
May 15, 2013 -- The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Prostate cancer forms in a gland in the male reproductive...
Read more...FDA Approves Simponi to Treat Ulcerative Colitis
Posted 1 weeks ago in New Drug Approvals
May 15, 2013 -- The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis...
Read more...FDA Approves Generic Zomig and Zomig-ZMT Tablets
Posted 1 weeks ago in Pharma Industry News
May 15, 2013 -- The U.S. Food and Drug Administration today approved the first generic versions of Zomig and Zomig-ZMT tablets. Zomig (zolmitriptan) belongs to the class of drugs called triptans, and is indicated for the acute treatment of migraine with or without aura in adults. Zomig was first approved in tablet form in November 1997, and Zomig-ZMT orally disintegrating tablets followed in February 2001 as an...
Read more...Arbor Pharmaceuticals Announces FDA Approval of Nymalize
Posted 1 weeks ago in New Drug Approvals
May 13, 2013 - Atlanta, GA - Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize (nimodipine) oral solution. Nymalize was previously granted Orphan designation which provides seven years of market exclusivity. Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in...
Read more...U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
Posted 1 weeks ago in New Drug Applications
RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of...
Read more...Endo Health Solutions Responds to FDA's Denial of Opana ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone
Posted 1 weeks ago in Pharma Industry News
MALVERN, Pa., May 10, 2013 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals Inc. Endo presented FDA data collected from an ongoing epidemiology study that indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant...
Read more...FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
Posted 2 weeks ago in New Drug Approvals
May 10, 2013 -- The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of...
Read more...Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis
Posted 2 weeks ago in New Drug Approvals
Basel, May 10, 2013 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous...
Read more...Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450
Posted 2 weeks ago in Pharma Industry News
WATERTOWN, Mass.--May 6, 2013--Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie’s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV)...
Read more...Drugs.com Releases Q1 Sales for Top 100 U.S. Drugs: Rough U.S Flu Season Boosts Numbers for Tamiflu
Posted 2 weeks ago in Pharma Industry News
NEW YORK, May 6, 2013 /PRNewswire/ — Drugs.com, the leading online clinical drug resource, today released first quarter 2013 U.S. prescription sales data for the top 100 drugs. The top five drugs have minor shifts in rank but exhibit positive growth for Q1 2013. Abilify, Otsuka’s second generation antipsychotic, and Nexium, AstraZeneca’s leading acid blocker, rank as the top two drugs by sales for the...
Read more...Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication
Posted 2 weeks ago in Pharma Industry News
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion AUDIENCE: Risk Manager, Pharmacy, Oncology ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up...
Read more...AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk Evaluation in Treatment of Advanced Renal Cell Carcinoma
Posted 3 weeks ago in New Drug Applications
CAMBRIDGE, Mass. and TOKYO, Japan, May 2, 2013 - AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC)...
Read more...Regulatory Update: Trametinib US PDUFA Date Extended to 3 September 2013
Posted 3 weeks ago in New Drug Applications
GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013. The company recently submitted additional manufacturing data to the Food and Drug Administration (FDA) and the extension to the original PDUFA goal date is to allow sufficient time for FDA to review the submission. On 3 August 2012, GSK...
Read more...Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application
Posted 3 weeks ago in New Drug Applications
SOUTH SAN FRANCISCO, CA--(Marketwired - Apr 30, 2013) - Titan Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued this evening a Complete Response Letter (CRL) to its New Drug Application (NDA) for Probuphine, the company's investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients. "Titan and our partner, Braeburn Pharmaceuticals,...
Read more...Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease
Posted 2 days ago in Clinical Trials
-- Clinical Trial in Patients with Huntington's Disease Slated to Begin Next Quarter -- SEATTLE, May 23, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an...
Read more...Spring Bank Pharmaceuticals Initiates a Phase I Clinical Trial for SB 9200 in HCV-infected Patients
Posted 2 days ago in Clinical Trials
MILFORD, Mass., May 23, 2013 /PRNewswire/ -- Spring Bank Pharmaceuticals, Inc., a biopharmaceutical company developing innovative medicines for the treatment of viral infections, today announced that it has initiated dosing in a Phase I study of SB 9200, its investigational, once daily, oral therapy for the treatment of HCV infection. This study will be conducted in healthy, HCV-infected patients...
Read more...Virobay, Inc. initiates a Phase 1 Trial of VBY-036, a compound intended for the treatment of neuropathic pain
Posted 2 days ago in Clinical Trials
MENLO PARK, Calif., May 23, 2013 /PRNewswire/ -- Virobay, Inc. today announced that their development of an oral treatment for pain has reached an important milestone, as Virobay has now initiated a Phase 1 clinical trial of VBY-036 - a selective cathepsin S inhibitor. The first Phase 1 trial of VBY-036 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety,...
Read more...Clinical trial tests targeting prostate cancer treatment
Posted 2 days ago in Clinical Trials
Study to evaluate whether drug works better against tumors with specific genetic anomaly ANN ARBOR, Mich., May 23, 2013 /PRNewswire-USNewswire/ -- Are certain drugs more effective against some types of prostate cancers than others? Researchers know that not all therapies work for all patients – the next question is to figure out how to match the right treatments with the right patients. A new...
Read more...First patient dosed in the Phase I/II study of Umecrine Mood’s candidate drug for premenstrual dysphoric disorder
Posted 2 days ago in Clinical Trials
STOCKHOLM – May 23, 2013. Umecrine Mood AB announced today that dosing has been initiated in a randomized Phase I/II study of UC1010 for the treatment of patients with premenstrual dysphoric disorder (PMDD). Umecrine Mood is part of the Karolinska Development portfolio. Most women experience some form of symptoms the days before menstruation but in about five percent of young and middle-aged...
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