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  • 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
  • Box: Considering CGRP

    Getting ahead of headache Considering CGRP Migraine is associated with elevated levels of calcitonin gene-related peptide (CGRP), a multifunctional neuropeptide that plays multiple roles in the central and …

    Published on 9/19/2016
  • Box: Oral persistence

    Getting ahead of headache Oral persistence Several companies are developing small molecule antagonists of calcitonin gene-related peptide for migraine treatment and prevention. Peter Goadsby, a King's College …

    Published on 9/19/2016
  • Table: Chronic migraine comps

    Getting ahead of headache Chronic migraine comps In chronic migraine prevention, differences in study designs used by developers of mAbs against calcitonin gene-related peptide (CGRP) or its receptor make it …

    Published on 9/19/2016
  • Table: Episodic migraine comps

    Getting ahead of headache Episodic migraine comps Data from 12-week Phase II trials to prevent episodic migraine do not show any obvious differentiation among four mAbs targeting calcitonin gene-related peptide (…

    Published on 9/19/2016
  • Getting ahead of headache

    How anti-CGRP mAbs may fare in the migraine prevention space

    Anti-CGRP mAbs are safe and effective enough to expand the migraine prevention market, but getting there will take time.

    Published on 9/19/2016
  • Executive power

    Executive agencies, not Congress, will be pharma's greatest threats in Washington

    Congressional investigations are getting attention now, but drug pricing action in the next administration will likely come from the executive branch.

    Published on 9/12/2016
  • Box: Who's on the bench

    Executive power Who's on the bench Three veterans of the Obama White House who helped craft and implement the Affordable Care Act (ACA) are advisers to Hillary Clinton and are candidates for influential jobs if …

    Published on 9/12/2016
  • Table: Biopharma friends

    Executive power Biopharma friends Some of the pharma industry's top supporters in Congress are in close races this year. In the Senate, allies under threat include Richard Burr (R-N.C.), Rob Portman (R-Ohio), and …

    Published on 9/12/2016
  • Table: Powering price constraints

    Executive power Powering price constraints The next administration will have many options to use executive authority to tackle drug spending. The table shows selected proposals from Hillary Clinton, the Medicare …

    Published on 9/12/2016
  • Progressive ideas

    Think tank with Clinton ties proposes comparative effectiveness requirements

    The Center for American Progress wants to align drug prices with value. Hillary Clinton agrees.

    Published on 9/12/2016

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