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The Centers for Disease Control and Prevention said it will issue draft guidelines next week recommending a one-time HCV test for all U.S. baby boomers -- the generation born between 1945-65. The agency said the …
Published on 5/18/2012
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Sen. Tom Harkin (D-Iowa) introduced a provision to the PDUFA reauthorization bill that would require HHS to include patient input during product development and regulatory discussions. The bill is under consideration by…
Published on 5/16/2012
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CMS's Medicare Evidence Development & Coverage Advisory Committee voted 14-0 that an evidentiary threshold can be defined to trigger a review of coverage with evidence development for a product or service to determine …
Published on 5/16/2012
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FDA reviewed novel therapeutics significantly faster than EMA and Health Canada during 2001-10, and the majority of those products were first approved in the U.S., according to a study by Yale University researchers. …
Published on 5/16/2012
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FDA's Center for Biologics Evaluation and Research (CBER) partnered with the World Health Organization to research new vaccine trial designs and ways to enhance postmarketing surveillance of vaccine safety. CBER plans …
Published on 5/15/2012
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HHS published a national plan to develop new prevention and treatment approaches for Alzheimer's disease by 2025. The Obama administration's proposed FY13 budget provides a $100 million increase over the amount …
Published on 5/15/2012
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The U.S. Senate version of PDUFA reauthorization legislation (S. 2516) would provide FDA with about $6.4 billion in user fees over 2013-17, according to a report from the Congressional Budget Office. The estimate …
Published on 5/14/2012
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The U.K.'s NICE is asking for comments on an advisory panel's recommendation to increase the value attached to a drug's long-term benefit when calculating cost-effectiveness estimates per quality-adjusted life year (…
Published on 5/11/2012
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The U.S. House Energy and Commerce Committee voted 46-0 on Thursday to send the PDUFA reauthorization bill to the full House. Rep. Joe Barton (R-Texas) withdrew an amendment that would have reduced user fees by 20% if …
Published on 5/10/2012
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CMS's Medicare Evidence Development & Coverage Advisory Committee posted the agenda for a May 16 meeting to review the characteristics of evidence required for the agency's Coverage with Evidence Development (CED) …
Published on 5/10/2012
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An Indian parliamentary report found there is sufficient evidence of a "collusive nexus" between the country's drug regulator and pharmaceutical companies to expedite approval of drugs. The report cites data from a …
Published on 5/10/2012
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At a drug pricing policy meeting Friday in Lund, Sweden, Germany's Federal Joint Committee (G-BA) Chairman Rainer Hess said, "We are not against innovation. We have too much 'innovation' in Germany, and we must lower …
Published on 5/9/2012
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The Bill & Melinda Gates Foundation awarded a $1 million grant each to six existing projects under its Grand Challenges Explorations initiative, and awarded 107 new $100,000 grants for global health and development …
Published on 5/9/2012
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The U.S. House Energy and Commerce Committee's health subcommittee voted unanimously on Tuesday to pass a draft PDUFA reauthorization bill. A full committee vote on the draft is expected Thursday. Rep. Fred Upton (R-…
Published on 5/8/2012
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The U.S. House Energy and Commerce Committee posted a new draft PDUFA reauthorization bill that is more closely aligned with the Senate PDUFA bill than previous versions. Changes that reflect the Senate bill include …
Published on 5/7/2012
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FDA's Medical Countermeasure Initiative is revising draft guidance of the Animal Rule, Chief Scientist Jesse Goodman said in an update for the FDA Science Board on Wednesday. The rule allows marketing approval to be …
Published on 5/4/2012
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NIH's new National Center for Advancing Translational Science (NCATS) unveiled its first initiative, partnering with three pharmas to repurpose compounds. AstraZeneca plc (LSE:AZN; NYSE:AZN); Eli Lilly and Co. (NYSE:LLY…
Published on 5/3/2012
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The German Association of Research-based Pharmaceutical Companies (VFA) called for drug pricing negotiations with the Statutory Health Insurance Funds Association (GKV-Spitzenverband) to be kept confidential under the …
Published on 5/3/2012
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FDA will hold a public workshop on June 7 to discuss methods for assessing REMS goals. The agency said the input from the meeting will be used to develop guidance on the subject.
Published on 5/2/2012
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France formally launched the National Agency for the Safety of Medicines and Health Products (ANSM), which replaces the French Health Products Safety Agency (Afssaps). The new agency was created last year in response to…
Published on 5/2/2012
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FDA met its predefined performance goals in 10 of 11 years between FY2000-10, according to a report from the U.S. Government Accountability Office. Specifically, FDA met its goal to have 90% of priority applications …
Published on 5/1/2012
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The Institute of Medicine said FDA should consolidate benefit-risk information for approved drugs into publicly available repositories created for each product. In a report released Tuesday, IOM said the agency already …
Published on 5/1/2012
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The U.S. Court of Appeals for the Federal Circuit will hold oral arguments on July 20 to reconsider Association for Molecular Pathology, et al. v. U.S. PTO, et al., a suit about the eligibility of genes for patenting. …
Published on 4/30/2012
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The U.S. Senate Committee on Appropriations on Thursday passed a FY13 appropriations bill for agriculture, rural development and FDA that would increase overall FDA funding to $2.5 billion, not including user fees. FDA …
Published on 4/26/2012
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The Biotechnology Industry Organization (BIO) named six legislators of the year for 2011-12: Sens. Michael Enzi (R-Wyo.), Kay Hagan (D-N.C.), Robert Menendez (D-N.J.); Reps. Allyson Schwartz (D-Pa.), Jack Kingston (R-Ga…
Published on 4/25/2012