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  • Lilly's history lesson

    Commercial execution key to growth for incoming Lilly CEO Ricks

    Job one for Lilly's incoming CEO will be to execute on drug launches to maintain growth in the face of still more patent expirations.

    Published on 10/24/2016
  • Figure: Cliff jumpers

    Lilly's history lesson Cliff jumpers During John Lechleiter's eight years as president and CEO, new launches by Eli Lilly and Co. (NYSE:LLY) plugged the gaps from blockbuster patent expirations including cancer …

    Published on 10/24/2016
  • Figure: Lilly's launch pad

    Lilly's history lesson Lilly's launch pad During John Lechleiter's tenure as president and CEO Eli Lilly and Co. (NYSE:LLY) will have launched 10 drugs. Seven of these will be three years old or less, including …

    Published on 10/24/2016
  • Accounting for input

    Why NICE put the kibosh on including patients on appraisal committees

    Why NICE won't invite patients to participate in appraisal committees — and how patients still hope to influence decision making.

    Published on 10/17/2016
  • Making ICER nicer

    Why ICER policy changes likely won't satisfy patients or drug companies

    It's unlikely that policy changes ICER is considering will satisfy patients or drug companies.

    Published on 10/10/2016
  • Table: 4Q milestones

    ASH and others 4Q milestones Selected products with clinical or regulatory milestones expected in 4Q16. Source: BCIQ: BioCentury Online Intelligence Company Product Indication Event Milestone AcelRx …

    Published on 10/3/2016
  • Dressed in black

    Biotech winners, losers in 3Q16

    For the first time in more than two years, all biotech market cap bands finished in the black.

    Published on 10/3/2016
  • Figure: London vs. Europe

    Dressed in black London vs. Europe The BioCentury Europe index rose 4% in 3Q16, edging it into positive territory for the year with a 0.4% gain after nine months. Fifteen of the 19 continental European companies …

    Published on 10/3/2016
  • Figure: Price-to-earnings: BT vs. RX

    Dressed in black Price-to-earnings: BT vs. RX Biotech's average P/E ended 3Q at 18.2, a four-year low. The P/E is down 26% from 2Q16 and 10% from 3Q15. The 3Q16 decline would have been steeper were it not for …

    Published on 10/3/2016
  • Figure: Results by market cap

    Dressed in black Results by market cap All market cap tiers gained in 3Q16, but still remain under water year to date. The biggest gains in 3Q16 came in the $200-$499 million tier, where gainers outnumbered …

    Published on 10/3/2016
  • Table: 3Q approvals

    Dressed in black 3Q approvals Selected 3Q approvals. Company Approval Amgen Inc. (NASDAQ:AMGN) FDA approves Amjevita adalimumab-atto, a biosimilar of autoimmune drug Humira adalimumab Aralez Pharmaceuticals …

    Published on 10/3/2016
  • Table: Index performance

    Dressed in black Index performance Index 3Q16 YTD BioCentury 100 15% -14% NASDAQ Biotechnology 12% -14% NYSE Arca Biotechnology 11% -12% NASDAQ Composite 10% 6% BioCentury London 5% 4% BioCentury…

    Published on 10/3/2016
  • Table: Restructuring watch

    Dressed in black Restructuring watch At least 12 companies reported workforce reductions in the third quarter compared to at least one in the same period last year. Table below is sorted by date ascending. All …

    Published on 10/3/2016
  • ASH and others

    Investors' top names and milestones in 4Q16

    With ASH taking center stage, the fourth quarter is bubbling with milestones.

    Published on 10/3/2016
  • Figure: Biotech fund flows

    Reasonable rally Biotech fund flows Biotech funds flows are down $4.8 billion year to date, and $432.5 million in 3Q16. Outflows for the quarter were tempered by inflow of $118 million in September. In the first …

    Published on 10/3/2016
  • Table: Follow-on performance

    Reasonable rally Follow-on performance Forty-one companies raised $3.3 billion in 3Q16, topping the tallies for the first and second quarters. The $7.2 billion raised to date in 2016 is still well below the $24.5 …

    Published on 10/3/2016
  • Table: IPO performance

    Reasonable rally IPO performance Seventeen companies raised $1.3 billion in IPOs in the third quarter, though about half of that came from the $618.8 million New York listing of Dutch contract research and …

    Published on 10/3/2016
  • Table: IPO queue

    Reasonable rally IPO queue At least nine companies have announced plans to go public since the start of 3Q16, bringing the IPO queue to at least 18. Unless noted, companies are seeking to list on NASDAQ. Filings …

    Published on 10/3/2016
  • Reasonable rally

    Why biotech's rally should continue in 4Q16, but not at the pace of the prior quarter

    Biotech's rebound should continue through year end, but not with the same gusto that characterized the third quarter.

    Published on 10/3/2016
  • How much is enough?

    Digging in to FDA's scientific dispute about DMD drug Exondys 51

    FDA's Woodcock and Unger disagreed on one fundamental question about Exondys 51: how much dystrophin expression predicts clinical benefit in DMD?

    Published on 9/26/2016
  • Digging into dosing

    How Sarepta, FDA can determine dose for Exondys 51's confirmatory trial

    Sarepta's scanty clinical program gives small clues to choosing a dose of Exondys 51 that will produce enough dystrophin.

    Published on 9/26/2016
  • Box: Bungled

    Not so fast Bungled Despite a difference of opinion whether to grant accelerated approval to Exondys 51 eteplirsen from Sarepta Therapeutics Inc., senior FDA officials and review staff agree the biotech badly …

    Published on 9/26/2016
  • Box: Defending Woodcock

    Not so fast Defending Woodcock FDA Commissioner Robert Califf used a memo about disputes over the accelerated approval of Sarepta Therapeutics Inc.'s Exondys 51 eteplirsen to air and refute criticisms that have …

    Published on 9/26/2016
  • Not so fast

    Why approval of Exondys 51 might be a setback for patient-focused regulation

    Approval of Exondys 51 was both a resounding victory for DMD advocates, and a likely setback for patient-focused regulation.

    Published on 9/26/2016
  • Wrong again

    Why Sarepta's $300K price for DMD drug invalidates reasons for accelerated approval

    If the $300,000 price tag Sarepta put on Exondys limits the drug's use to a fraction of DMD patients, there was no point to accelerated approval.

    Published on 9/26/2016

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