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Weekly Drug News Round Up - October 29, 2014

Pfizer’s Trumenba Approved as First Vaccine for Group B Meningococcal Disease

In meningococcal disease bacteria can invade the bloodstream (sepsis), the brain and spinal cord lining (meningitis) Read More…

Recent outbreaks of potentially deadly group B meningitis on U.S. college campuses created concern. Today, the U.S. Food and Drug Administration (FDA) approved Trumenba (meningococcal group B vaccine), the first vaccine approved to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 10 through 25 years of age. In studies, after three doses, 82 percent of study participants had antibodies in their blood compared to one percent before vaccination. Other vaccines approved for meningococcal disease only cover four of the five main serogroups of N. meningitidis: A, C, Y, and W.

Baxter’s Obizur Approved for Rare Acquired Hemophilia A

Obizur contains a recombinant analogue of porcine (pig) FVIII which is less likely to be inactivated in these patients Read More...

Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder. The U.S. Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A. In acquired hemophilia A, immune system proteins inactivate FVIII, another protein important for blood clotting. Without normal clotting, a person can bleed excessively. Obizur received orphan drug designation by the FDA because the drug is intended for use in treatment of a rare disease or condition.

Sotylize Approved as First Oral Sotalol Solution

Arbor Pharmaceuticals will launch Sotylize in the first quarter of 2015 Read More...

Sotylize (sotalol hydrochloride) oral solution is an anti-arrhythmic indicated for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation or flutter. The U.S. Food and Drug Administration has approved Arbor’s Sotylize as the first marketed sotalol oral solution indicated for the treatment of these life-threatening ventricular arrhythmias. Prior to Sotylize, a pharmacist often had to compound the solution from the sotalol tablets. As with certain other anti-arrhythmics, sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation.

Merck’s Keytruda Designated as Breakthrough Therapy for Advanced NSCLC

Keytruda is being studied across more than 30 types of cancers, as monotherapy and in combination Read More...

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. Keytruda is a human PD-1 (programmed death receptor-1)-blocking antibody. This is the second Breakthrough Therapy Designation granted for Keytruda following its approval in September for advanced melanoma. Merck continues to pursue FDA approval of Keytruda for treatment of NSCLC.

FDA Update: Mixing Meds and Dietary Supplements Can Be Risky

A CDC report found that some 72 million people in the US were taking a dietary supplement along with a prescription drug Read More...

Prescription drugs are well known for drug interactions with other prescription drugs. But what about interactions with dietary supplements like over-the-counter vitamins, minerals, and herbs? Yes. It can and does happen. Dietary supplements such as St. John’s Wort, ginkgo biloba, vitamin E and melatonin can have numerous interactions. One of the most serious interactions that can occur is between blood thinners like warfarin and certain herbal supplements. Consumers need to understand that even though a label might say “natural”, these products are not always safe. Check with your pharmacist or other health care provider to check for drug interactions before using any dietary supplement.