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Arena's lorcaserin could carve out a niche in obesity despite limited efficacy and potential hurdles to use, including an FDA committee's call for baseline and annual echocardiograms.
Published on 5/14/2012
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Now that an FDA panel voted to recommend Truvada to prevent HIV, the next step is for FDA and Gilead to address calls for a strict REMS, including potential mandates for HIV testing.
Published on 5/14/2012
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Companies may need to enlarge and enrich placebo groups in RA trials to show significance on radiographic endpoints, given ethical concerns that limit how long patients can be on placebo.
Published on 5/14/2012
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A longer weight Two birds, one trial Novo Nordisk A/S is developing diabetes drug Victoza liraglutide for obesity and is hopeful that its fully enrolled cardiovascular outcomes trial in diabetics will be enough to …
Published on 4/9/2012
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A longer weight Doubling up Obesity companies may need to double the size of their Phase II and III programs if FDA follows a panel's recommendation to hold obesity drugs to the same standard as diabetes drugs in …
Published on 4/9/2012
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Drug companies worry CMS's expansion of coverage with evidence development could hinder patient access to new drugs, but some clinical groups and policy specialists think the opposite could be true.
Published on 4/9/2012
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Following an outcry over its assessments of Orphan drugs and complaints about comparators used to assess the benefits of new drugs, Germany's G-BA is adjusting course.
Published on 4/9/2012
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Two measures being developed in Washington could offset the burden of extensive CV risk assessment of drugs to treat obesity. Both could shift the paradigm toward subgroups and away the broader population.
Published on 4/9/2012
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FDA may soon approve the first new obesity drug in more than a decade, but the prospect of new cardiovascular studies prior to approval could mean next-generation compounds won't be available for 5-6 years.
Published on 4/9/2012
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FDA's ODAC reminded sarcoma drug developers that statistical significance is not necessarily clinically meaningful as the panel voted down Taltorvic from Merck and Ariad, while GSK's Votrient cleared the bar.
Published on 3/26/2012
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Shire's withdrawal of its Replagal BLA is a classic case of 'he said, she said,' with the company and FDA pointing fingers at each other and Fabry's disease patients caught in the middle.
Published on 3/26/2012
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Feasible, perhaps not relevant FDA on cUTI Key components of FDA's draft guidance for the design of clinical trials in complicated urinary tract infection (cUTI). Source: FDA Study component Criteria Design …
Published on 3/19/2012
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Cubist and Achaogen say it is feasible to conduct trials under FDA's draft guidance on complicated urinary tract infections. But clinicians warn the data won't apply to clinical practice in the U.S.
Published on 3/19/2012
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Congress is likely to pass legislation to expand accelerated approval as part of PDUFA V, but BIO and FDA have different opinions about the scope and pace of change the law would produce.
Published on 3/12/2012
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A beefed up REMS and clearer safety profile won Vivus' Qnexa a positive FDA panel vote, but other obesity candidates under review can't count on finding the same success.
Published on 2/27/2012
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Vivus: Back for seconds A revamped REMS One of the deciding factors for last week's FDA advisory panel on Qnexa phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS) was the detailed REMS provided by the company to …
Published on 2/27/2012
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Vivus: Back for seconds Tracking teratogenicity Since the July 2010 FDA advisory committee meeting to review the original NDA for Qnexa phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS), there have been three …
Published on 2/27/2012
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The TREAT Act has morphed from a radical revision of FDA's approval standards into a congressional exhortation for the agency to aggressively apply its existing accelerated approval regulations.
Published on 2/20/2012
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Because Amgen's Xgeva is already approved for metastatic CRPC, getting approval in non-metastatic disease will likely require a new trial comparing the drug's use in both settings.
Published on 2/13/2012
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FDA's biosimilars guidances make clear there will be no cookie-cutter biosimilars pathway. Instead, there will be a highly interactive process between FDA and sponsors for each product, with a high analytical bar.
Published on 2/13/2012
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Bob Temple's new focus on clinical science at FDA means that for the first time in recent memory, he will not be the last word on reviews of drugs for cardiology and renal indications.
Published on 2/6/2012
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Although NICE is supposed to recommend access to expensive drugs by small patient populations under special end-of-life criteria, the track record is that cost is still driving the decisions.
Published on 2/6/2012
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Small does have a price Pounds over patients Recommendations for several drugs appraised by the U.K.'s National Institute for Health and Clinical Excellence under its end-of-life criteria indicate that the price of …
Published on 2/6/2012
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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