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EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is in the process of drafting a consultation that will lay out the rules of procedure for public hearings on the safety of marketed drugs or classes of medicines.…
Published on 6/18/2013
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FDA is holding a public workshop on July 23 to discuss preclinical methods to assess arrhythmia risk including the risk of torsades de pointes during the drug development process as an alternative to clinical thorough …
Published on 6/18/2013
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The American Society of Clinical Oncology and more than 50 other advocacy organizations sent a letter to HHS and the U.S. Department of Labor requesting regulations or guidance by January on a provision of the …
Published on 6/18/2013
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Japan's Ministry of Health, Labor and Welfare (MHLW) last week withdrew its recommendation of HPV vaccination pending further review of safety data related to systemic pain, according to GlaxoSmithKline plc (LSE:GSK; …
Published on 6/18/2013
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NIH's National Center for Advancing Translational Science (NCATS) awarded $12.7 million to nine academic research groups to repurpose compounds from pharma partners under a pilot initiative. The groups will evaluate the…
Published on 6/18/2013
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India is in the process of developing a health technology assessment board and the country's Department of Health Research signed a memorandum of understanding (MOU) with the U.K.'s NICE to help with the process. NICE …
Published on 6/17/2013
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A spokesperson said Rep. Michael Burgess (R-Texas) plans to introduce within the next few weeks a bill that would allow the Congressional Budget Office to expand the time period over which it calculates the budgetary …
Published on 6/14/2013
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EMA will hold a workshop on Nov. 26 to discuss providing parallel scientific and regulatory advice with health-technology assessment (HTA) bodies in the drug development process. The workshop will examine an ongoing …
Published on 6/14/2013
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FDA published final guidance on the co-development of two or more new investigational drugs. The final guidance reiterates language in 2010 draft guidance on how to choose and test combinations of investigational new …
Published on 6/14/2013
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Lawmakers on the House Appropriations Committee are continuing to work to exempt future FDA user fees from sequestration, but in the meantime the committee voted to send to the full U.S. House of Representatives a FY14 …
Published on 6/14/2013
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The U.S. Patent and Trademark Office issued preliminary guidance to patent examiners instructing them to reject product claims "drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or…
Published on 6/14/2013
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FDA is actively investigating concerns that glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors -- collectively known as incretin mimetics -- could cause pancreatitis, Janet …
Published on 6/14/2013
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FDA published a final rule that clarifies language in Orphan Drug regulations, including when a compound may be eligible for Orphan Drug designation for a subset of patients with a non-rare disease. The final rule …
Published on 6/12/2013
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The British Medical Journal published a report that says companies have not done "critical safety studies" to address concerns that glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) …
Published on 6/11/2013
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FDA issued a proposed rule listing pathogens that would be eligible for drug development incentives under the Generating Antibiotic Incentives Now (GAIN) Act. The pathogens are: species of Acinetobacter, Aspergillus, …
Published on 6/11/2013
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The Department of Justice said FDA will make Plan B One-Step levonorgestrel, a single-dose formulation emergency contraceptive from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), available OTC without any age …
Published on 6/11/2013
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EMA issued draft guidance updating and clarifying 2006 guidance on the non-clinical and clinical requirements for developing biosimilars. According to the draft, comparative efficacy trials will be required for most …
Published on 6/10/2013
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The Critical Path Institute named John-Michael Sauer as executive director of the Predictive Safety Testing Consortium (PSTC). Sauer previously was senior director of in vitro pharmacology and DMPK at Pfizer's CovX …
Published on 6/10/2013
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George Washington University researchers asserted in a press release that a new analysis shows that relaxed rules on conflict of interest waivers for FDA advisory committee meetings "could weaken the agency's review …
Published on 6/7/2013
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FDA granted an Emergency Use Authorization (EUA) to CDC for its CDC Novel Coronavirus 2012 Real-time RT-PCR Assay, an in vitro diagnostic to detect Middle East respiratory syndrome coronavirus (MERS-CoV). The …
Published on 6/7/2013
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A session of Germany's lower house of Parliament (Bundestag) ended on Thursday without a vote on a bill containing an amendment to guidelines implementing drug pricing law AMNOG. The amendment would eliminate the …
Published on 6/6/2013
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The lower house of German Parliament (Bundestag) will vote Thursday on a bill that includes an amendment that would eliminate the requirement for Germany's Federal Joint Committee (G-BA) to conduct benefit assessments …
Published on 6/5/2013
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An appeals court decision means FDA must make two-pill versions of emergency contraceptives containing levonorgestrel available OTC without any age restrictions, though one-pill versions will still be subject to age …
Published on 6/5/2013
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FDA issued draft guidance on developing antiretrovirals to treat HIV-1 infection that recommends sponsors seek full approval of therapies from the outset -- shifting away from prior practice of seeking accelerated …
Published on 6/5/2013
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An international group of about 70 hospitals, universities and research institutions including NIH signed a letter of intent to create a not-for-profit to share genomic and clinical data. According to a white paper …
Published on 6/5/2013