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  • Table: 2Q15 milestones

    Q is for quiet 2Q15 milestones Selected products with Phase III or regulatory milestones expected in 2Q15. (A) Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is acquiring Auspex Pharmaceuticals Inc. (NASDAQ:ASPX…

    Published on 4/6/2015
  • Figure: London vs. Europe

    Up, up and acquired London vs. Europe The BioCentury Europe index gained 12% last quarter, while the BioCentury London index appreciated 2%. Advancers outpaced decliners 15 to 4 in the BC Europe. Medigene AG (…

    Published on 4/6/2015
  • Figure: Price-to-earnings: BT vs. RX

    Up, up and acquired Price-to-earnings: BT vs. RX The average biotech and big pharma P/Es each increased by about 10% from 4Q14. The average biotech P/E gained 11% to 24.9 from 22.4 in 4Q14. Multiples for Biogen …

    Published on 4/6/2015
  • Figure: Results by market cap

    Up, up and acquired Results by market cap Nearly all market cap segments ended 1Q15 in positive territory, with the top two posting gains of more than 8%. Companies valued above $5 billion gained 8.3%, led by 50%-…

    Published on 4/6/2015
  • Table: 1Q approvals

    Up, up and acquired 1Q approvals and setbacks Selected first quarter approvals. Company Approval AbbVie Inc. (NYSE:ABBV)/Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) EC approves Exviera dasabuvir and Viekirax …

    Published on 4/6/2015
  • Table: Index performance

    Up, up and acquired Index performance Index 1Q15 BioCentury 100 19% NYSE Arca Biotechnology 16% NASDAQ Biotechnology 13% BioCentury Europe 12% NYSE Arca Pharmaceutical 7% NASDAQ Composite 3% …

    Published on 4/6/2015
  • Table: Restructuring watch

    Up, up and acquired Restructuring watch At least five companies announced plans to restructure in the first quarter compared with at least two in the same period last year. All cash and operating loss figures in $…

    Published on 4/6/2015
  • Fundamental rally

    Why buysiders see biotech rally extending into 2Q15

    Confidence in the large caps has buysiders expecting biotech's rally to extend into 2Q15 as M&A and financing activity continue.

    Published on 4/6/2015
  • Up, up and acquired

    Winners, losers in biotech stock tiers in 1Q15

    For the first time since 1Q14, none of the biotech market cap segments lost ground.

    Published on 4/6/2015
  • Ready for PRIME time

    Biogen gambles that aducanumab Phase 1b can define the therapeutic window

    Biogen is betting it can find a dosing window to take aducanumab straight to Phase III for Alzheimer's on big but exploratory efficacy results.

    Published on 3/30/2015
  • Table: Comparing the AD data

    Ready for PRIME time Comparing the AD data It's hard to compare the data for mAbs against beta amyloid to treat Alzheimer's disease because of differences in patients' baseline cognitive status, whether amyloid …

    Published on 3/30/2015
  • Show me the value

    How Medicines Co. develops drugs to show both health and economic benefits

    Medicines Co. is using simulations, early clinical readouts and economic outcomes research to show how its products deliver value.

    Published on 3/23/2015
  • Box: DIY patient engagement

    The 21cc solution DIY patient engagement The House Energy & Commerce Committee captured the biomedical public policy zeitgeist by putting patient-focused drug development at the top of the 21st Century Cures …

    Published on 3/16/2015
  • The 21cc solution

    Why Congress will end up with a less ambitious 21st Century Cures initiative

    Congressional efforts to put a stamp on biomedical innovation will be pared down by political and economic realities, so the challenge will be creating the most impact through a few initiatives.

    Published on 3/16/2015
  • Prepping for PCSK9s

    How Sanofi should think about pricing/rebates for first-to-market PCSK9 inhibitor

    Sanofi and Regeneron deprived Amgen of a head start with its PCSK9 inhibitor, but now they'll have to go first in a game of chicken with payers.

    Published on 3/9/2015
  • Box: HCV recap, ICYMI

    Prepping for PCSK9s HCV recap, ICYMI As new mAbs against PCSK9 are launched, payers and manufacturers alike will be working within a new pricing and reimbursement paradigm shaped in large part by the launches of HCV…

    Published on 3/9/2015
  • Box: Crucell's new job

    Prevention by the pound Crucell's new job The Janssen Prevention Center will develop vaccines for use in the general population to prevent non-infectious diseases, such as Alzheimer's disease (AD), cardiovascular …

    Published on 3/2/2015
  • Prevention by the pound

    Why Janssen created stand-alone group to stop diseases from starting

    After several years of exploration, Janssen has concluded that stopping diseases before they start requires a dedicated group separate from its therapeutic area teams.

    Published on 3/2/2015
  • Box: Virtuoso approval

    Calming the pendulum Virtuoso approval FDA's approval of the Maestro Rechargeable System from EnteroMedics Inc. marks a turning point for the use of patient preference data to make regulatory decisions. Instead of…

    Published on 2/23/2015
  • Calming the pendulum

    What industry, FDA must do to realize the potential of patient engagement

    Why patient engagement is the top priority for PDUFA reauthorization and the 21st Century Cures initiative.

    Published on 2/23/2015
  • Start the experiments

    Road map to Medicaid/Medicare fixes for new drug pricing models

    Companies can start laying the groundwork now to change Medicaid rules and usher in new drug pricing models.

    Published on 2/16/2015
  • Box: Cracking the code

    Start the experiments Cracking the code The way Medicaid calculates best price has more to do with the existing coding system than with how the law is written, and the codes are a barrier to alternative pricing …

    Published on 2/16/2015
  • Box: Medicare spillover

    Start the experiments Medicare spillover Models that depart from per-unit drug pricing could perpetuate or exacerbate a pre-existing problem that has been attributed to the ASP calculation used to determine …

    Published on 2/16/2015
  • Figure: Slippery slope

    Start the experiments Slippery slope Companies fear that innovative pricing schemes that abandon per-unit pricing in favor of performance- or value-based pricing could lead to huge rebates for all Medicaid …

    Published on 2/16/2015
  • Hamburg's legacy

    How FDA Commissioner Hamburg left behind a better FDA

    Margaret Hamburg's legacy includes a depoliticized FDA, higher budgets and a focus on innovation and patient engagement.

    Published on 2/9/2015

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