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Diagnostic survival test Déjà vu This month's MEDCAC panel on DNA- and RNA-based tests for cancer of unknown primary site was not the first time payers have requested data above and beyond that required for …
Published on 5/13/2013
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MEDCAC has again served notice that diagnostics can expect to face a higher evidence bar for reimbursement than is required for marketing approval, even if the data will be difficult to obtain in the post-market.
Published on 5/13/2013
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While the first meeting under FDA's Patient-Focused Drug Development initiative focused only on chronic fatigue syndrome, it did make clear the challenges the agency faces in making use of anecdotal information.
Published on 5/6/2013
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FDA's starting lineup Patient focus, round one Under PDUFA V, FDA committed to hold a series of meetings to obtain patient input on 20 diseases as part of the agency's Patient-Focused Drug Development initiative. …
Published on 5/6/2013
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Some of the 16 diseases FDA selected for its first round of meetings under the Patient-Focused Drug Development initiative are obvious choices, while others are real head-scratchers.
Published on 5/6/2013
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By choosing to test Breo in nine Phase IIb dose-selection studies, plus more than 5,000 patients in Phase III, GSK and Theravance may have set the benchmark for novel LABA/steroid combinations for COPD.
Published on 4/22/2013
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A collaboration of EU member states, patients and industry have developed a framework to assess the value of Orphan drugs that could be used as the basis for pricing negotiations at the national level.
Published on 4/15/2013
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While sponsors may wish for more access to FDA's benefit-risk framework, the scheme will force the agency to document its regulatory thinking and provide a tool to resolve internal conflicts about regulatory actions.
Published on 3/25/2013
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FDA's AD guidance is being hailed or attacked as a transformative step toward unleashing new drugs. Both hype and hope are misplaced: the needed scientific and regulatory breakthroughs don't yet exist.
Published on 3/25/2013
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Reframing FDA Patient-Focused Drug Development At an Oct. 25, 2012, public meeting, FDA asked for patient input on what diseases should be the focus of 20 patient-focused meetings it has promised over the next five …
Published on 3/25/2013
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Reframing FDA The framework FDA's proposed benefit-risk framework lays out five decision factors intended to standardize the components of the benefit-risk assessment for drug and biologics reviews. For each factor,…
Published on 3/25/2013
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AMNOG could soon leave German diabetics with few choices: make do with metformin or sulfonylureas, use insulin, or cross the border to buy newer drugs out of pocket.
Published on 3/18/2013
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Dissecting Kadcyla Final question While Genentech Inc. has already launched Kadcyla ado-trastuzumab emtansine for metastatic breast cancer, one question remains begging at FDA: How much market exclusivity will the …
Published on 3/11/2013
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Dissecting Kadcyla On deck in MBC At least 26 compounds are in Phase II or Phase III testing with advanced or metastatic breast cancer as the lead indication. Formulations of already marketed drugs, or compounds …
Published on 3/11/2013
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Drug companies still hoping to win accelerated approval in metastatic breast cancer will want to study FDA's thinking about Genentech's Kadcyla.
Published on 3/11/2013
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The deadline to finalize the U.K.'s value-based pricing system is fast approaching. But patient groups have yet to be invited to the negotiating table, while an EU-funded study is challenging the value of QALYs.
Published on 3/11/2013
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Affymax's Omontys will reinforce a de facto two-speed system of FDA approvals under which timelines are getting shorter for targeted agents, and longer for drugs intended for use in broad populations.
Published on 3/4/2013
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Two-speed system Salving safety concerns The trifecta of a novel adjuvant, a broad population and alternatives on the market sunk Dynavax Technologies Corp.'s first attempt to gain approval for its Heplisav HBV …
Published on 3/4/2013
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A more complete telling of FDA's review of the diabetes drug illuminates the agency's reluctance to accept uncertainty about the safety of treatments it considers incremental improvements over existing therapies.
Published on 3/4/2013
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Controversy has flared around FDA's proposed limited-use pathway, with BIO prepared to endorse a broader application while pushback from PhRMA likely means the idea will be limited to antibiotics.
Published on 2/25/2013
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To reap the benefits of its more than $200 billion investment in life sciences, China needs to streamline and expand SFDA, while removing restrictions that make it the last stop for global drug developers.
Published on 2/25/2013
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FDA's dogged effort to uncover a potential cardiovascular risk associated with Novo Nordisk's insulin degludec products effectively raised the bar for approval twice.
Published on 2/18/2013
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The outcome of litigation brought by Novartis against the German Federal Joint Committee could determine the agency's ability to beat down prices for drugs that are already on the market.
Published on 2/18/2013
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Departing FDA neurology division Director Russell Katz now gets high marks from drug developers and patient groups, but they say his successor will need to be more risk-tolerant if new drugs are to reach patients.
Published on 2/11/2013
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Boehringer sidestepped problems that delayed a once-daily LABA from Novartis by designing a robust development program that produced a clear dose response for olodaterol in COPD.
Published on 2/4/2013