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AMNOG's uncharted waters IQWiG tally Of the nine drugs to receive a preliminary benefit assessment from IQWiG, six have been found to provide an additional benefit in at least one subgroup patient population, but no…
Published on 1/30/2012
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Germany's new drug pricing law doesn't say how the country's statutory health insurance will price drugs that show benefit in only some patients. AstraZeneca's Brilique may be the first test case.
Published on 1/30/2012
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Expanding acceleration ULTRA controversy In addition to the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which will be considered first by the Senate, legislation has been …
Published on 1/23/2012
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FDA and industry agree accelerated approval needs to be expanded, but whether the agency proceeds on its own depends on whether both sides can agree on legislative approaches to include in PDUFA V.
Published on 1/23/2012
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The EC's new antibiotic action plan could widen the regulatory gap with the U.S., which is already at the point where some physicians worry companies will no longer seek FDA approval of their antibiotics.
Published on 12/19/2011
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Europe speeds away Clinical flatline The number of companies conducting clinical trials of antibacterial compounds stayed about the same since liver toxicity issues with Ketek telithromycin emerged in 2006, leading …
Published on 12/19/2011
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Europe speeds away Antibiotics in Phase III At least nine antibacterial compounds are in Phase III trials, but none of the 10 studies of those compounds target the most urgently needed indications: hospital-acquired…
Published on 12/19/2011
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InterMune argues Esbriet's Orphan status for IPF will protect the drug from a steep price cut despite a negative preliminary benefit assessment in Germany. Investors were less convinced.
Published on 12/19/2011
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After a positive panel vote and little push back from FDA for peginesatide, Affymax's toughest battle may be capturing share in a market dominated by Amgen and its preemptive deals with dialysis providers.
Published on 12/12/2011
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FDA says companies looking to use patient reported outcomes would be wise to follow the example of Incyte's Jakafi -- the first cancer drug approved in the last decade based in part on a PRO.
Published on 12/5/2011
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Sir Michael Rawlins, chairman of NICE, says excessive premarket regulatory requirements are increasing the costs of drug development - and drug prices - without providing commensurate benefits to patients.
Published on 12/5/2011
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CMS is revamping its coverage with evidence development program to more broadly stimulate collection of clinical data where innovations do not neatly fit into coverage mandates.
Published on 11/21/2011
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Pressure from Capitol Hill and the media influenced CMS's decision to conduct a national coverage review for Provenge. The message is Medicare will take a close look at new drugs that generate political controversy.
Published on 11/21/2011
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Provenge politics The "boring story" When CMS announced its decision to consider a national coverage policy for prostate cancer drug Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN), the agency said it was …
Published on 11/21/2011
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Inching toward feasibility Bacterial pneumonia pipeline Two drugs have been approved in recent years in Europe for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP), but not in the U.S. …
Published on 11/14/2011
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Working with BIO, Democratic Sen. Kay Hagan has drafted legislation to create a progressive approval pathway, which could effectively expand accelerated approval to virtually all applications for NMEs.
Published on 11/14/2011
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The latest advisory panel meetings on clinical trial design for pneumonia suggest FDA and the clinical community are closer to agreement on CABP but are not yet on the same page on HABP/VABP.
Published on 11/14/2011
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The fight over companion diagnostics boils down to what information goes onto a drug's label, which will determine whether companies or pathologists have more control over which tests are used.
Published on 11/7/2011
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Based on the same methodology it used to recommend against PSA screening, the U.S. Preventive Services Task Force said more evidence is needed to evaluate HPV screening for cervical cancer in women over 30.
Published on 10/31/2011
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While the medical community debates a U.S. task force's recommendation against PSA screening for prostate cancer, the implications for all preventive services and diagnostics are far broader.
Published on 10/31/2011
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Lessons from PSA debate Refining PSA Doctors say methods for refining the use of PSA scores could provide more accurate results than the methods used in studies from the 1990s reviewed by the U.S. Preventive …
Published on 10/31/2011
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Various groups already are working on technologies that are likely to complement PSA screening, and may offer the potential to replace it altogether.
Published on 10/31/2011
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A narrow window has opened for agency reformers as Congress begins work on PDUFA and the Obama administration looks for support from business as it moves into election mode.
Published on 10/24/2011
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NICE is setting an impractical hurdle in lupus for Benlysta -- a comparison with MabThera, a drug that failed in Phase III trials for SLE and that the NHS is increasingly refusing to pay for.
Published on 10/17/2011
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The political debate has shifted from safety at all costs, as both industry and regulators agree it's time to fix the drug development crisis. The question is how to turn a consensus into concrete change.
Published on 10/3/2011