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EMA released the first details of an agency reorganization following a December announcement of a review and intended reorganization. The agency said its Human Medicines Development and Evaluation and its Patient Health…
Published on 5/3/2013
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FDA Commissioner Margaret Hamburg announced in an internal memo that Leona Brenner-Gati departed as acting deputy commissioner for medical products and tobacco due to unexpected personal circumstances. Brenner-Gati …
Published on 5/3/2013
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Rep. Brian Higgins (D-N.Y.) introduced into the U.S. House of Representatives the Cancer Drug Coverage Parity Act, which would require insurers to provide coverage of patient-administered oral and injectable cancer …
Published on 5/3/2013
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CMS's Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) concluded on Wednesday that existing evidence is sufficient to confirm the clinical validity of DNA- or RNA- based testing to predict the …
Published on 5/1/2013
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The U.K.'s NICE will take over responsibility for an NHS program that was created in 2007 to work with companies and the NHS to promote the adoption and use of new technologies recommended by NICE. NICE -- which renamed…
Published on 5/1/2013
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EMA published final advice from five groups of stakeholders on how to implement the agency's plan to proactively release clinical data for approved drugs, which is slated to go into force on Jan. 1, 2014. The agency, …
Published on 4/30/2013
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Sally Howard will join FDA as deputy commissioner for policy, planning and legislation, effective May 6, according to an internal memo from FDA Commissioner Margaret Hamburg. Howard was chief of staff to HHS Secretary …
Published on 4/29/2013
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President Obama said the U.S. "could lose a year, two years of scientific research as a practical matter" due to sequestration cuts, which he said could hamper scientific research. In a speech at the annual meeting of …
Published on 4/29/2013
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CMS released meeting material including an agenda and speaker list ahead of a May 1 meeting of its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss technology assessments for two types of …
Published on 4/26/2013
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A group of senators on the U.S. Senate Health, Education, Labor and Pensions (HELP) committee released a discussion draft of a bill that would make compounding manufacturers -- including those that repackage products …
Published on 4/26/2013
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EMA published an initial list of medicines that are subject to additional monitoring in the EU and will be required to bear an inverted black triangle on packaging and labeling starting in September. The requirement …
Published on 4/25/2013
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FDA granted an Emergency Use Authorization on Monday to the Centers for Disease Control and Prevention for a diagnostic that can detect the new H7N9 avian influenza virus circulating in China. The PCR-based diagnostic …
Published on 4/25/2013
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A bipartisan group of 124 members of the U.S. House of Representatives sent a letter to CMS Acting Administrator Marilyn Tavenner seeking information on the agency's implementation of 2% sequester cuts to reimbursement …
Published on 4/25/2013
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Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) published draft revisions that would update the methods document describing the institute's legal and scientific procedures to reflect its current …
Published on 4/24/2013
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The Scottish government is forming the Stratified Medicine Scotland Innovation Centre (SMS-IC) to evaluate genomic data and individual responses to treatments to identify strata of responders/non-responders and to …
Published on 4/24/2013
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Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) sent a letter to FDA Commissioner Margaret Hamburg voicing support for the agency's proposed limited-use drug approval pathway for serious or life-threatening …
Published on 4/24/2013
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The Wellcome Trust named Jeremy Farrar as director, effective Oct. 1. Farrar is a professor at Oxford University and director of the Oxford University Clinical Research Unit in Vietnam, an infectious disease research …
Published on 4/24/2013
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The Biotechnology Industry Organization (BIO) appointed Rachel King chairman for 2013-14. King is president and CEO of GlycoMimetics Inc. (Gaithersburg, Md.) and was BIO's vice chair of health and formerly chair of …
Published on 4/23/2013
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FDA launched the Patient Network website through which the public can apply to become a patient representative, comment on FDA regulations, report adverse events and attend FDA webinars. A calendar of FDA's public …
Published on 4/23/2013
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The U.S. Senate Finance Committee voted unanimously by voice vote in favor of confirming Marilyn Tavenner as CMS administrator. Tavenner has been CMS's acting administrator since Donald Berwick stepped down in December …
Published on 4/23/2013
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The American Society of Clinical Oncology is seeking comments on draft recommendations on ranges of overall survival (OS) improvements in Phase III trials that provide a "meaningful benefit" for patients with four types…
Published on 4/22/2013
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According to a European Commission report to be presented Tuesday at the BIO International Convention, biosimilars are increasing competition and helping to stabilize healthcare costs. The report notes that as …
Published on 4/22/2013
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Rep. Michael Burgess (R-Texas) reintroduced the Making Investments Now for Dementia (MIND) Act, which would authorize the treasury to issue bonds to fund Alzheimer's disease research at NIH. The bill (H.R. 1619) was …
Published on 4/19/2013
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A bipartisan group of U.S. Senators released a discussion draft of legislation that would create a national system for tracking and tracing pharmaceutical products. Under the proposal, HHS would develop standards for …
Published on 4/19/2013
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A group of Democratic lawmakers introduced a bill on Tuesday that would require manufacturers to pay rebates for drugs sold to "dual-eligibles" --individuals who receive both Medicaid and drug coverage through Medicare.…
Published on 4/16/2013