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Weekly Drug News Round Up - April 16, 2014

GSK’s Tanzeum Approved: A Once-Weekly Injection for Type 2 Diabetes

Tanzeum has a boxed warning that thyroid tumors have been seen in rodent studies with similar drugs Read More...

Tanzeum (albiglutide) is a newly approved glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels in patients with type 2 diabetes. Tanzeum is given by subcutaneous (under the skin) injection, and as with most diabetes treatments, is to be used alongside diet and exercise. The safety and effectiveness of Tanzeum was shown in eight clinical trials involving over 2,000 participants with type 2 diabetes. Tanzeum was studied alone and in use with other type 2 diabetes treatments, including metformin, glimepiride, pioglitazone, and insulin. Byetta and Victoza are other drugs in the same class as Tanzeum.

Merck’s Grastek Approved for Grass Pollen Allergies

New sublingual (under the tongue) immunotherapies like Grastek and Oralair can offer patients alternatives to allergy shots Read More...

The U.S. Food and Drug Administration (FDA) has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an under-the-tongue tablet used for the treatment of grass pollen allergies with or without conjunctivitis (red, itchy eyes) for people allergic to Timothy grass or related grass pollens, as determined by a skin or blood test. Grastek can be used in persons 5 through 65 years of age. Unlike certain antihistamines, Grastek is not indicated for the immediate relief of allergic symptoms. On April 2, 2014 the FDA also approved Oralair, another sublingual tablet to treat grass pollen allergies.

FDA Consumer Update: Irritable Bowel Syndrome Treatments

Irritable bowel syndrome (IBS) affects about 15.3 million people in the United States Read More...

Doctors do not know what causes irritable bowel syndrome (IBS) and there is no known cure, as reported by the U.S. Food and Drug Administration (FDA). IBS is a gastrointestinal disorder that affects the large intestine but doesn't cause inflammation or permanent damage. Common symptoms of IBS include diarrhea or constipation (or alternating between both), abdominal pain and bloating, gas, and stool mucus. Symptoms may come and go. After attempts at diet and lifestyle changes, prescription medications may be an option, such as Linzess (linaclotide) for constipation-predominant IBS and chronic constipation, Amitiza (lubiprostone) for IBS with constipation and Lotronex (alosetron) for IBS with diarrhea.

NEJM: AbbVie’s Hepatitis C Drug Approaches 95 Percent Cure Rate

Nearly 3 million Americans have hepatitis C, a disease that can cause liver cirrhosis and cancer Read More...

An investigational hepatitis C virus (HCV) treatment called ABT-450 is closing in on a 95 percent cure, as published in the New England Journal of Medicine (NEJM) last week. In a Phase 3 trial, close to 400 patients took a placebo or a combination of ABT-450 and other HCV treatments. All patients had previously been unsuccessfully treated for HCV. ABT-450 is an oral pill that requires a 3 month treatment. Other new generation, interferon-free regimens are making new ground in HCV treatment and cure, too, including Gilead’s oral Sovaldi (sofosbuvir). According to experts, year-long interferon injections are no longer needed to cure hepatitis C.

Zohydro ER Ban Lifted in the State of Massachusetts

In March, Zohydro ER, void of abuse-deterrent technology, was launched into the U.S. prescription drug market Read More...

Drug company Zogenix has prevailed in what was thought to be the first-ever attempt by a state to block the sale of an FDA-approved drug. Massachusetts Governor Deval Patrick instituted a ban on the hydrocodone painkiller Zohydro ER due to concern over soaring drug addiction, overdoses and deaths in his state. On Tuesday, U.S. District Court Judge Rya Zobel made a final decision, and the U.S. District Court in Massachusetts entered an order preventing the implementation of the Zohydro ER ban on constitutional grounds. The federal court order takes effect on April 22.

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