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Raptor is launching an ultra-Orphan drug it has shown is non-inferior to a cheaper alternative without having payers on board with the $250,000 price. It is banking on quality of life gains from better compliance.
Published on 5/20/2013
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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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Two years into the job at Sanofi, Elias Zerhouni has shaken up the company's R&D structure, dumped programs and reoriented toward disease biology. But he says the real evidence of change won't come until 2016.
Published on 4/29/2013
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Zerhouni's progress report Sanofi then & now Since he began his strategic review in early 2009, Elias Zerhouni, head of global R&D at Sanofi (Euronext:SAN; NYSE:SNY), has focused on advancing programs with novel …
Published on 4/29/2013
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Zerhouni's progress report Sanofi's discontinued programs Sanofi (Euronext:SAN; NYSE:SNY) is no longer purusing 19 of the 27 NMEs that were in Phase II or Phase III/registration at the start of 2009. Some of the …
Published on 4/29/2013
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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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With the most stocked clinical pipeline among its RNAi peers, Alnylam has made the leap from platform to products, providing a case study for the use of IP for company building and sustainable finance.
Published on 4/15/2013
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IP armamentarium Alnylam chronicles With so many of its early years devoted to figuring out RNAi delivery, Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) had to depend on its investors, who weren't always patient, …
Published on 4/15/2013
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IP armamentarium Dealing in RNAi As it transitions from a pure platform play to a product company, Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) continues to do deals for its RNAi technology as well as partnerships for…
Published on 4/15/2013
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Rather than clarify FDA's autonomy to make science-based decisions, a federal judge's rebuke of HHS on emergency contraceptives might open the door to more challenges to agency decisions via the courts.
Published on 4/8/2013
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Buysiders remain bullish on biotech but are on the lookout for signs of a top, and suggest companies -- which are spending cash as fast as they raise it -- should take advantage of the sellers' market while it lasts.
Published on 4/1/2013
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Buysiders are being drawn to mid- and small cap biotechs with solid balance sheets and/or near-term inflection points going into 2Q13, a period that may be relatively quiet for some of the sector's largest names.
Published on 4/1/2013
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Looking for 'growthier' Healthcare/biotech fund flows So far this year, healthcare/biotech funds have had net inflows of $3.5 billion, more than any of the full year totals for the past decade. The best performing …
Published on 4/1/2013
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Looking for 'growthier' Peaks & troughs Since the 2008-09 economic crisis, the BioCentury 100 and NASDAQ Biotechnology indices have had run-ups of 40-75% before falling back. Prior to the crisis, these run-ups …
Published on 4/1/2013
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Looking for 'growthier' Spending needs Change in total spending for R&D and SG&A by market cap segment from YE10 through YE12. BioCentury's analysis of biotechs valued above $200 million shows the average operating …
Published on 4/1/2013
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Looking for 'growthier' Still no exit An IPO window has yet to open despite the strong follow-on activity and significant increase in the BioCentury 100 Index since the 2008-09 economic crisis. Historically, a surge…
Published on 4/1/2013
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Looking for 'growthier' Follow-on performance The biotech industry raised $2.3 billion via 31 follow-on deals in 1Q13. This compares to $2.1 billion via 35 deals in 1Q12. In the after-market, the range of gains and …
Published on 4/1/2013
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Looking for 'growthier' IPO performance In 1Q13, six companes raised $322.9 million through IPOs vs. eight that raised $459.3 million in 1Q12. MedRx Co. Ltd. (Tokyo:4586) was up 3.5X at March 29, as retail investors…
Published on 4/1/2013
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Looking for 'growthier' IPO queue At least 13 companies have proposed IPOs, including one being spun out of a biotech. Harvard Apparatus Regenerative Technology Inc. is being spun out of Harvard Bioscience Inc. (…
Published on 4/1/2013
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Manning the middle 2Q13 milestones Selected products with Phase III or regulatory milestones expected in 2Q13. Source: BCIQ: BioCentury Online Intelligence Company Product Indication Event Milestone AcelRx …
Published on 4/1/2013
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For the second year in a row, biotech put together a strong showing in the first quarter, with all market segments gaining ground. The sector was led by mid-caps, which closed up 16%.
Published on 4/1/2013