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  • Box: Rapid biosimilars uptake

    FDA's rocket docket Rapid biosimilars uptake Richard Pazdur, director of the Office of Hematology and Oncology Drug Products in FDA's Center for Drug Evaluation and Research, predicts biosimilars will be adopted …

    Published on 4/20/2015
  • Box: Targeting ovarian cancer

    FDA's rocket docket Targeting ovarian cancer FDA's December 2014 approval of Lynparza olaparib, the first targeted therapy for ovarian cancer, could stimulate more drug development for ovarian cancer, according to…

    Published on 4/20/2015
  • Figure: Beating the clock

    FDA's rocket docket Beating the clock Since the start of 2013, FDA has approved 38 new or supplemental applications for cancer drugs. Twenty-three were approved at least two weeks before their PDUFA dates, 16 at …

    Published on 4/20/2015
  • Table: Trial designs

    FDA's rocket docket Trial designs FDA is speeding cancer drugs to market by allowing sponsors to use single-arm and open-label trials, and by approving products based on response rate and progression-free survival…

    Published on 4/20/2015
  • FDA's rocket docket

    Richard Pazdur on why FDA is racing to approve cancer drugs

    FDA's Richard Pazdur says scientific advances are producing better drugs, prompting the agency to race to approve them faster.

    Published on 4/20/2015
  • PRO progress

    How FDA, industry and patient community can increase number and quality of PROs

    FDA's proposed PRO compendium is a good start, but a precompetitive consortium and guidance could help accelerate patient-centric PROs.

    Published on 4/13/2015
  • Box: Two PRO system

    PRO progress Two PRO system PROs in the U.S. can be developed one of two ways — specifically for a given clinical candidate or independent of a specific drug development program via FDA's qualification process. …

    Published on 4/13/2015
  • Figure: Biotech fund flows

    Fundamental rally Biotech fund flows About $3.8 billion flowed into biotech funds last quarter, compared with $4.3 billion of net inflows in 1Q14. The BioCentury 100 gained 19% in 1Q15. The March fund flows figure…

    Published on 4/6/2015
  • Table: Follow-on performance

    Fundamental rally Follow-on performance Ninety-two biotechs raised $11.3 billion in 94 follow-ons in 1Q15, matching the total raised in the full year 2014. Excluding the $1.5 billion raised by Valeant …

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

    Fundamental rally IPO performance Biotech companies raised $2 billion in 22 IPOs in 1Q15. The total is less than the $2.6 billion raised by 36 companies in 1Q14, but has only slowed slightly from 4Q14, when 24 …

    Published on 4/6/2015
  • Table: IPO queue

    Fundamental rally IPO queue At least 18 companies have announced plans to go public since the start of 1Q15, bringing the IPO queue to at least 32. Unless noted, companies are seeking to list on NASDAQ. Most …

    Published on 4/6/2015
  • Q is for quiet

    Investors look for cancer immunotherapy combination, gene therapy data in 2Q15

    With few big pending approvals, investors expect a quiet start to 2Q15 before a deluge of cancer immunotherapy combo data at ASCO.

    Published on 4/6/2015
  • 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

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