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February 26, 2013News for the food and drug law community

  Drugs & Biologics 
  • Analysis: Recall could make FDA more cautious about biosimilars
    The recall of Affymax's anemia drug Omontys could prompt more caution from the FDA as it develops a pathway for the approval of biosimilar drugs, former FDA official Dr. Scott Gottlieb writes. "The agency has years of experience with biological agents that simulate red blood cell production, and the inability to ferret out the risks with Omontys is likely to underscore how hard this science remains," he writes. Forbes (2/25) Email this Story
  • FDA OKs Bayer's Stivarga for gastrointestinal stromal tumor
    The FDA approved Bayer HealthCare's Stivarga, or regorafenib, to treat patients with metastatic, locally advanced or unresectable gastrointestinal stromal tumors. The drug, which previously had been cleared for metastatic colorectal cancer, will be marketed in the U.S. with Onyx Pharmaceuticals. RTT News (2/25), Reuters (2/25) Email this Story
  • Amneal gets FDA nod for generic Suboxone
    The FDA has granted Amneal Pharmaceuticals approval for its buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets to address opioid dependence. The drug is the generic formulation of Suboxone from Reckitt Benckiser Healthcare. Drug Store News (2/25) Email this Story
  • FDA seeks more data on Dynavax hepatitis B vaccine Heplisav
    The FDA declined to approve Heplisav, an hepatitis B vaccine developed by Dynavax Technologies, and asked for more information on safety. In a complete response letter, the agency said it is open to a more limited use. Dynavax plans to meet with the FDA within six weeks. Reuters (2/25) Email this Story
  • Health care would see sweeping changes under sequestration
    Spending cuts mandated under sequestration, looking increasingly likely, will touch nearly all aspects of health care, including potentially forcing layoffs or furloughs at the FDA. "The FDA is having enough trouble retaining their good people," said Dan Mendelson of Avalere Health. "I would expect approval times to suffer as a result." Delaying Affordable Care Act provisions such as exchanges could help prevent the cuts, according to Republican Gov. Bobby Jindal of Louisiana. The Hill/Healthwatch blog (2/24), The Washington Post/Post Politics blog (2/24) Email this Story
  • Ky. House committee clears reforms to Rx drug law
    Kentucky's House Judiciary Committee unanimously approved changes to a law designed to clamp down on prescription drug abuse. The law has unintentionally put sick patients at the same level of scrutiny as potential traffickers, said state House Speaker Greg Stumbo. Under the changes, a 14-day exemption follows surgical procedures, and hospitals and long-term care facilities are exempted from the requirements. Lexington Herald-Leader (Ky.)/The Associated Press (2/25) Email this Story
Top 8 Obstacles in Pharma & Biologics Product Registration & Submission Management
For pharmaceutical and biologics companies, the path to a global product launch is full of obstacles that could result in delays to registrations, many of which can be avoided with the help of automation. This white paper identifies some of the most common problems in managing submissions for the purpose of product registration and how best to address them. Download the whitepaper.
  Food & Dietary Supplements 
  • USPSTF: Postmenopausal women should not take vitamin D, calcium
    Noninstitutionalized postmenopausal women should not take vitamin D and calcium supplements, as they do not show efficacy in preventing fractures and are associated with higher risk of kidney stones, the U.S. Preventive Services Task Force stated. It is unclear whether the supplements work for younger populations, according to the statement published in the Annals of Internal Medicine. Family Practice News (2/25), Reuters (2/25) Email this Story
  Medical Devices 
  • Biotronik wins FDA nod for single-lead, atrial-sensing ICD
    The FDA has granted Biotronik approval for its implantable cardioverter defibrillator that uses advanced sensors and the company's LinoxsmartS DX lead to allow doctors to monitor and detect atrial arrhythmias with just one lead. The device, called Lumax 740 DX System, is targeted for implantation in the U.S. starting late this month or early next month. Healio (2/25), CNET (2/25) Email this Story
  FDLI Items 
  • Registration open: Controlled Substances Regulation, March 28 in Washington
    Join us for this one-day conference that will focus on significant developments in FDA's and DEA's regulation of controlled substances. The program brings together government, industry and public interest experts to provide updates on the latest regulations and legislation affecting controlled substances' stakeholders. Participants will discuss key developments after passage of the Food and Drug Administration Safety and Innovation Act; important scheduling and rescheduling situations from the past year; and enforcement updates. The program will also feature a roundtable on the recently issued draft guidance on abuse-deterrent opioids, featuring FDA participation and a diverse group of industry and public interest representatives. Panelists will engage attendees in interactive dialogue on current hot topics and ongoing legal and policy decisions. Register by Feb. 28 to get the early bird rate. Email this Story

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Czech writer

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