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  • Would you rather?

    How patient preference data make patient engagement real

    Data from patient preference surveys are being integrated into drug development to improve adherence, design target profiles and inform regulatory decisions.

    Published on 6/29/2015
  • Box: Devices first

    Would you rather? Devices first FDA's Center for Devices and Radiological Health has been in the vanguard of the agency's efforts to solicit patient preference data and use it to support approval decisions. In …

    Published on 6/29/2015
  • Box: Structuring benefits and risks

    Would you rather? Structuring benefits and risks The structured benefit-risk framework, a tool FDA uses for organizing and communicating benefit-risk assessments, may be one way to get patient preference data into …

    Published on 6/29/2015
  • Figure: $100M club

    Finance follows function $100M club The number of $100 million-plus venture equity rounds announced in a given year jumped sharply to nine in 2014, while prior years had seen at most three such deals. So far in …

    Published on 6/22/2015
  • Figure: Age of affluence

    Finance follows function Age of affluence Last year, private biotechs raised $9 billion — the most on record since BioCentury started tracking the data in 1994. So far in 2015, the industry has raked in $5.9 …

    Published on 6/22/2015
  • Finance follows function

    Why some VCs want their companies to spend freely in times of plenty

    VCs are opening their wallets for platforms and want their biotechs to do the same. The logic is spending increases valuations.

    Published on 6/22/2015
  • Figure: LDL Limbo

    LDL in context LDL Limbo With no outcomes data for the PCSK9 inhibitors Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) and Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals …

    Published on 6/15/2015
  • Table: First on deck

    LDL in context First on deck There are at least five hypercholesterolemia and dyslipidemia programs in the clinic with potentially first-in-class mechanisms. Source: BCIQ: BioCentury Online Intelligence Company…

    Published on 6/15/2015
  • LDL in context

    What FDA PCSK9 panel says about LDL as a surrogate of CV benefit

    An FDA panel's vote for narrowed indications for PCSK9 mAbs Repatha and Praluent signal where LDL may and may not be an acceptable surrogate for CV benefit.

    Published on 6/15/2015
  • Box: Two baskets

    Overcoming origins Two baskets NCI expects to enroll the first of about 1,000 patients in NCI-MATCH in July. The study includes solid tumors or lymphomas harboring "actionable mutations" targeted by approved drugs…

    Published on 6/8/2015
  • Table: Basket trial roundup

    Overcoming origins Basket trial roundup At least six so-called basket trials studying genetically defined cancers across a broad spectrum of tissues of origin are under way, with at least two more slated to start …

    Published on 6/8/2015
  • Table: Target matching

    Overcoming origins Target matching The NCI-MATCH study will match patients to targeted therapies based on molecular abnormalities of their tumors, regardless of the tissue of origin. The study is starting with 10 …

    Published on 6/8/2015
  • Overcoming origins

    Why oncology drug development will remain tissue-dependent, for now

    Despite several trials studying targeted drugs across different tissue-defined cancers, the drug development and approval paradigm will remain tissue-bound for the foreseeable future.

    Published on 6/8/2015
  • Box: Rasi's annulment

    Innovators wanted? Rasi's annulment In November, the European Union Civil Service Tribunal annulled the 2011 appointment of Guido Rasi as executive director due to conflict of interest among members of the …

    Published on 6/1/2015
  • Innovators wanted?

    What new executive director could mean for EMA's innovative direction

    EMA's new executive director is due to be picked this summer, and the agency's predilections for regulatory innovation may ride on outcome.

    Published on 6/1/2015
  • Figure: Clinical rationing

    Cash cravings Clinical rationing The total raised by private and public European biotechs increased by 57% to $9 billion in 2014 from $5.8 billion in 2013. Funding for companies in the clinic or with a marketed …

    Published on 5/25/2015
  • Figure: Europe's total demand

    Cash cravings Europe's total demand BioCentury projects that private and public European biotech companies with compounds in the clinic and beyond will need a record $6 billion to keep their programs on track …

    Published on 5/25/2015
  • Figure: Private demand

    Cash cravings Private demand The aggregate three-year demand for private European biotechs in the clinic and beyond is estimated to be $5 billion, slightly below the $5.1 billion in last year’s survey. On a euro …

    Published on 5/25/2015
  • Figure: Public demand

    Cash cravings Public demand The aggregate three-year capital demand for unprofitable European public biotechs in the clinic and beyond reached $946.6 million, up 62% from $585.8 million in the 2014 survey. …

    Published on 5/25/2015
  • Table: New funds

    Cash cravings New funds Since the start of 2014, at least 30 life science funds with a European presence are raising or have raised a total of more than $9 billion. (A) Invests in private and public companies; (B)…

    Published on 5/25/2015
  • Innovation underfed

    Europe's Iceberg 2015: Finance at root of translational gap in innovation

    Innovation is a predictor of access to capital and partnering success, but investors say lack of the former is holding back Europe's innovators.

    Published on 5/25/2015
  • Figure: Capital rationing

    Innovation underfed Capital rationing In 2014, the average venture raised per private European company increased by 21% to $17.5 million from $14.4 million in 2013. The boost was helped by an unspecified $85 …

    Published on 5/25/2015
  • Figure: EU vs. U.S. private funds raised

    Innovation underfed EU vs. U.S. private funds raised Money raised by private U.S. companies increased by 61% to $6.5 billion in 2014 from 2013, while European private companies saw a 11% increase in funding to $1.…

    Published on 5/25/2015
  • Figure: EU vs. U.S. public funds raised

    Innovation underfed EU vs. U.S. public funds raised The top figure shows that the amount raised via equity financings by public European biotechs increased by 2.6x to $4.7 billion from 2013 vs. a 1.5x increase in …

    Published on 5/25/2015
  • Figure: Global competition for capital

    Innovation underfed Global competition for capital Total funding for both Europe and the U.S. increased from 2013 to 2014. The money raised by European companies increased by 57% to $9 billion, while U.S. …

    Published on 5/25/2015

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