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Level-headed enthusiasm IPO performance Thus far in 2013, 16 biotechs have raised $965 million from IPOs. Ten were completed in the second quarter for $636.6 million. The group is up a median of 26% from their …
Published on 6/17/2013
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Level-headed enthusiasm IPO queue At least 20 companies have proposed IPOs, including 14 announced since the start of April. Unless noted, the companies are seeking to list on NASDAQ. Most recent filing at top. (A) …
Published on 6/17/2013
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Bankers and buysiders agree: As long as quality companies remain on offer and valuations are fair, biotech IPOs will keep thriving as large cap performance and fund inflows mean investors have cash for new stories.
Published on 6/17/2013
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The latest panel review of the diabetes drug could provide insight into how FDA will make benefit-risk decisions in the postmarket as it is increasingly faced with a similar melange of real-world and clinical data.
Published on 6/10/2013
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Avandia's real lesson RECORD replay At last week's joint meeting of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committees on Avandia rosiglitazone, the returning panel …
Published on 6/10/2013
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As late-stage DMD companies approach the finish line, researchers already are looking toward a cocktail they think will ultimately be necessary to treat the majority of patients.
Published on 6/3/2013
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The DMD landscape DMD pipeline At least 10 compounds are in clinical development for Duchenne muscular dystrophy (DMD). The therapies include compounds that target the dysfunctional or absent dystrophin gene, as …
Published on 6/3/2013
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Demand disequilibrium Clinical rationing Europe's private and public biotechs in the clinic both raised more money in 2012 vs. 2011. Of the $1.2 billion raised by private biotechs in 2012, $806.3 million, or 66%, …
Published on 5/27/2013
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Demand disequilibrium Private demand Private European biotechs in the clinic and beyond will need an estimated $4.54 billion to support operations to the end of 2015, compared with a three-year estimate of $4.59 …
Published on 5/27/2013
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Demand disequilibrium Public demand Public European biotechs in the clinic and beyond, but have not yet reached a profit, will need an estimated $906.5 million to support operations to the end of 2015. This compares…
Published on 5/27/2013
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Demand disequilibrium New EU funds Since the start of 2012, at least 19 funds with a focus on life science investing in Europe have raised a total of more than $2.5 billion. (A) Fund was closed in 2010, but was re-…
Published on 5/27/2013
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BioCentury's 11th European Iceberg survey finds investors pushing companies to adapt to the new healthcare ecosystem by preparing assets to meet the needs of both payers and regulators.
Published on 5/27/2013
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BioCentury's 11th European Iceberg survey sees funding demand continue to fall for a shrinking number public clinical-stage biotechs in Europe, while underlying demand by a growing cadre of venture plays continues to …
Published on 5/27/2013
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Value reality check Capital rationing The average venture raised per European company was $12.8 million in 2012 vs. $11.8 million in 2011. The 2012 number includes a $150 million series B round by NovImmune S.A. …
Published on 5/27/2013
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Value reality check EU vs. U.S. private raised Private European biotechs raised $1.2 billion in 2012, the same amount as in 2011. In the U.S., private companies saw a 28% increase in venture money raised to $4.7 …
Published on 5/27/2013
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Value reality check EU vs. U.S. public raised Excluding debt, the top figure shows public biotechs in Europe increased their fundraising by 24% to $1.2 billion from 2011 vs. a 35% increase in the U.S. to $8.3 …
Published on 5/27/2013
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Demand disequilibrium Europe's total demand BioCentury projects that private and public European biotech companies with compounds in the clinic and beyond will need $5.5 billion over the next three years to keep …
Published on 5/27/2013
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Value reality check Global competition for capital The total money raised by European and U.S. biotechs declined in 2012, as 2011 and 2010 were bulked up by a series of large debt deals. The funding figure actually …
Published on 5/27/2013
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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