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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: Blum leaving CMS

    CMS Administrator Marilyn Tavenner announced in an internal memo that Jonathan Blum, principal deputy administrator, is departing the agency May 16. CMS declined to disclose details on his next steps or successor. Blum …

    Published on 4/22/2014
  • POLITICS & POLICY: FDA finalizes guidance on Orphan mAb sameness

    FDA published final guidance on how the agency determines the sameness of mAbs under the Orphan Drug Act. The final guidance now explicitly states that FDA "does not intend to apply the considerations discussed in this …

    Published on 4/22/2014
  • POLITICS & POLICY: FDA to hold meeting on opioid postmarketing requirements

    FDA is holding a public meeting on May 19-20 to obtain stakeholder input on the design and conduct of postmarketing requirements for extended-release and long-acting opioids. In September, FDA announced classwide …

    Published on 4/22/2014
  • POLITICS & POLICY: ACC, AHA to start including cost/value assessments

    The American College of Cardiology and American Heart Association are the latest physician groups to integrate value assessments for treatments into clinical practice guidelines and performance measures. In a joint …

    Published on 4/18/2014
  • POLITICS & POLICY: Mapi-Pharma sets IPO range

    Mapi-Pharma Ltd. (Ness Ziona, Israel) amended its IPO on NASDAQ and now plans to sell 2.9 million shares at $13-$15. At the $14 midpoint, the company would raise $40 million and be valued at $215 million. Aegis Capital …

    Published on 4/18/2014
  • POLITICS & POLICY: NCI researchers: cancer treatments costly to compare

    In an article published in the New England Journal of Medicine, researchers at NIH's National Cancer Institute made several proposals on how to fund comparative effectiveness trials for expensive new cancer drugs vs. …

    Published on 4/18/2014
  • POLITICS & POLICY: VA: doctors should defer HCV treatment for some

    The U.S. Department of Veteran Affairs recommended regimens containing Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and Olysio simeprevir from Johnson & Johnson (NYSE:JNJ) for most HCV patients, but said …

    Published on 4/18/2014
  • POLITICS & POLICY: HCV therapies cost UnitedHealth $100M in 1Q14

    On a conference call to discuss the company's 1Q14 earnings, UnitedHealth Group Inc. (NYSE:UNH) CFO Dan Schumacher said the insurer recorded a little more than $100 million in costs in the quarter for HCV treatments, …

    Published on 4/17/2014

    Most North American and European markets are closed on Friday, April 18, in observance of Good Friday. BioCentury Extra will publish as needed on Friday, and will resume regular postings on Monday, April 21.

    Published on 4/17/2014
  • POLITICS & POLICY: NHS England creates Sovaldi fund

    NHS England approved L18.7 million ($31.3 million) in funding to treat advanced HCV patients with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD). Treatment will be limited to patients at significant risk of …

    Published on 4/17/2014
  • POLITICS & POLICY: White House provides update on ACA figures

    Eight million people have enrolled in health plans offered on state and federal health insurance exchanges, according to figures released by the White House on Thursday. The number exceeds the 6 million the …

    Published on 4/17/2014
  • POLITICS & POLICY: Arizona compassionate use bill advances

    The Arizona Senate passed a bill that would allow physicians to prescribe investigational products to eligible terminally ill patients who have no "comparable or satisfactory" FDA-approved treatment options. The bill …

    Published on 4/16/2014
  • POLITICS & POLICY: FDA reschedules risk-benefit assessment meeting

    FDA rescheduled for May 12 a public meeting to be held with Institute of Medicine (IOM) to discuss sources of uncertainty in assessing the benefits and risks of drugs and the implications on regulatory decision-making. …

    Published on 4/15/2014
  • POLITICS & POLICY: EMA to hold workshop on Alzheimer's guidance

    EMA will hold a workshop on Nov. 24-25 to obtain stakeholder input on developing products for Alzheimer's disease and other dementias. The agency is in the process of updating 2008 guidelines on the topic and said the …

    Published on 4/14/2014
  • POLITICS & POLICY: Exchange patients using more specialty drugs

    Express Scripts Holding Co. (NASDAQ:ESRX) said use of specialty drugs was greater in January and February among enrollees on health exchanges compared with patients in commercial health plans. In an analysis, the …

    Published on 4/14/2014
  • POLITICS & POLICY: EU clarifies law on postmarket trials

    The European Commission adopted a delegated act that specifies limited circumstances under which EMA can require a postmarketing efficacy trial. EMA can require postmarketing efficacy when the initial efficacy …

    Published on 4/11/2014
  • POLITICS & POLICY: PhRMA names Read chairman

    The Pharmaceutical Research and Manufacturers of America elected Ian Read as chairman. Read is CEO and chairman of Pfizer Inc. (NYSE:PFE). He succeeds Robert Hugin, chairman and CEO of Celgene Corp. (NASDAQ: CELG). The …

    Published on 4/11/2014
  • POLITICS & POLICY: Solomon becomes permanent regulatory affairs deputy

    FDA named Steven Solomon as deputy associate commissioner for regulatory affairs for FDA's Office of Regulatory Affairs. Solomon has been acting deputy associate commissioner since January 2013. He will step down from …

    Published on 4/11/2014
  • POLITICS & POLICY: FDA seeking input on technologies to deter opioid abuse

    FDA opened a public docket to gather stakeholder input on how product packaging, storage and disposal systems could be used to prevent or deter opioid abuse and misuse "without diminishing access for patients with …

    Published on 4/10/2014
  • POLITICS & POLICY: Sebelius resigning

    Kathleen Sebelius is resigning as HHS secretary. Sebelius has been secretary since April 2009 and for the past few years has been responsible for helping to implement the Affordable Care Act. Last year, Sebelius asked …

    Published on 4/10/2014
  • POLITICS & POLICY: Lawmakers introduce bill for voluntary GMO labeling

    Reps. Mike Pompeo (R-Kan.) and G. K. Butterfield (D-N.C.) introduced in the U.S. House of Representatives the Safe and Accurate Food Labeling Act, which would give FDA sole authority to require mandatory labeling on …

    Published on 4/9/2014
  • POLITICS & POLICY: Rao joining New York Stem Cell Foundation

    Mahendra Rao will join the not-for-profit New York Stem Cell Foundation (NYSCF) Research Institute. He was founding director of NIH's Center for Regenerative Medicine.

    Published on 4/9/2014
  • POLITICS & POLICY: WHO HCV guidelines call for drug affordability

    The World Health Organization said stakeholders need to address the "unaffordable" cost of HCV treatments in its first set of guidelines on screening and treating the disease. WHO said a "concerted effort is needed to …

    Published on 4/9/2014
  • POLITICS & POLICY: CMS finalizes 2015 call letter

    In a final call letter, CMS said it awarded a contract to study beneficiaries' geographic access to pharmacies that offer preferred cost sharing plans and will evaluate whether it should set standards for network …

    Published on 4/8/2014
  • POLITICS & POLICY: EMA to consult with stakeholders on transparency policy

    EMA said it will meet with patient organizations, academia, industry and EU institutions at the beginning of May to discuss its plan to proactively release patient-level clinical trial data. In June, EMA's management …

    Published on 4/8/2014

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