Medical Tidbits, ADHD medications associated with diminished bone health in kids 

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PRNewswire-USNewswire/ — Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented today at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

“This is an important step in understanding a medication class, that is used with increasing frequency, and its effect on children who are at a critical time for building their bones,” said senior study author Jessica Rivera, MD, an orthopaedic surgeon with the U.S. Army Institute of Surgical Research.

ADHD is a common neurobehavioral condition often diagnosed in childhood. The U.S. Centers for Disease Control and Prevention (CDC) estimate 6.4 million children were diagnosed with ADHD through 2011. In addition, the CDC says that parents reported 3.5 million children and teenagers taking medications to treat ADHD, a 28 percent increase from 2007—2011. read more

Valeant Pharmaceuticals Announces Management Change

LAVAL, Quebec, March 2, 2016 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today confirmed that Deb Jorn has resigned as Executive Vice President, Company Group Chairman, effective immediately. In this role, she was responsible for running the company’s U.S. Dermatology and Gastrointestinal businesses. Eric Abramson, Vice President Dermatology & Immunology Marketing, has been appointed General Manager of the U.S. Dermatology business and Dr. Ari Kellen, Executive Vice President and Company Group Chairman will oversee Valeant’s gastrointestinal business.

Yondelis® Approved for Sale in 6 Additional Countries

Janssen Products, LP has informed PharmaMar (MSE:PHM) that regulatory authorities in 6 countries have granted 10 new authorisations to sell Yondelis®: five for treating relapsed platinum-sensitive ovarian cancer (ROC), in combination with Caelyx® (pegylated liposomal doxorubicin), and 6 as monotherapy for treating soft tissue sarcoma (STS).

The six countries that have authorised Yondelis® for ROC and/or STS are Saudi Arabia, Moldavia, Bangladesh, Brunei, Costa Rica and Kuwait.

As a result, Yondelis® is now approved in nearly 80 countries, 31 of which are in the European Economic Area (EEA). The European Commission approved Yondelis® for soft tissue sarcoma in 2007, and at the end of 2009 they approved the sale of this drug in combination with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer.

Merck, Pfizer and Verastem Announce Combination Trial of Avelumab and VS-6063 in Ovarian Cancer

DARMSTADT, Germany & NEW YORK & BOSTON–(BUSINESS WIRE)–Merck, Pfizer and Verastem announced today that they have entered into an agreement to evaluate avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Verastem’s VS-6063**, an investigational focal adhesion kinase (FAK) inhibitor, in patients with advanced ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types. The Phase I/Ib clinical trial is expected to begin in the second half of 2016. Financial terms of the agreement have not been disclosed. read more

ContraVir Pharmaceuticals Reports Positive Results Confirming the Safety of its Shingles Candidate FV-100 in a Drug-Drug Interaction Study  

/PRNewswire/ — ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, reported today a positive outcome from an important drug-drug interaction study regarding the Company’s novel antiviral drug candidate FV-100, which is currently in Phase 3 clinical development to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).

The drug-drug interaction study examined oral co-administration of FV-100 with ritonavir, a known inhibitor of the key drug metabolism enzyme CYP3A and the P-glycoprotein (P-gp) drug transporter, both of which are involved in a large number of adverse drug-drug interactions.  FV-100 was safe and well tolerated in this study. Importantly, the results showed that inhibition of CYP3A or P-gp by ritonavir or any other drugs that inhibit CYP3A or P-gp, is unlikely to elicit a clinically significant drug-drug interaction that could compromise the safety or efficacy of FV-100. read more

Heron Therapeutics Provides Update on SUSTOL® NDA

Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S. Food and Drug Administration (FDA) has informed the Company that it anticipates concluding its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection, extended release, by early April 2016. The Company is working closely with the FDA to facilitate the completion of its review. read more

Baxalta to Showcase Innovation Leadership in Primary Immune Deficiencies During 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting

BANNOCKBURN, Ill.–(BUSINESS WIRE)–Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, will present data highlighting its commitment to innovation in primary immunodeficiencies (PI) at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, March 4 – 7, 2016 in Los Angeles, California. read more

PixarBio Corporation’s Dr. Taunia Markvicka and Glenn Reiser to Discuss Breakthrough Data on Morphine Strength Non-Addictive Pain Treatment™ NeuroRelease™ at the 2016 Congress of Neurological Surgeons Spine Summit held in Orlando, FL March 17-18, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–PixarBio Corporation today announced that Dr. Taunia Markvicka its Chief Commercial Officer and Glenn Reiser its Director, Business Development will be available to discuss the company’s breakthrough Morphine Strength Non-Addictive Pain Treatment™ at the 2016 Congress of Neurological Surgeons Spine Summit meeting on Thursday, March 17, 2016 and Friday March 18, 2016 in Orlando, FL.  read more

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