Skip to main content
Home > BioCentury on BioBusiness > Cover Story

Chronological Index of : Cover Story

 Current Issue
  • Figure: N = 1

    Don't skip DMD patients N = 1 Billy Ellsworth, one of the DMD patients who participated in the trial of Sarepta's eteplirsen, and CDER Director Janet Woodcock at the April 25 advisory committee meeting for …

    Published on 5/2/2016
  • Just to confirm

    How Sarepta's eteplirsen confirmatory trials could support full approval

    Sarepta's planned eteplirsen confirmatory studies could generate evidence to support full approval without exposing exon-51 patients to placebo.

    Published on 5/2/2016
  • Box: Few ripples

    Just to confirm Few ripples Accelerated approval of eteplirsen from Sarepta Therapeutics Inc. would be unlikely to greatly complicate development of other DMD treatments. Summit Therapeutics plc CEO Glyn Edwards …

    Published on 5/2/2016
  • Don't skip DMD patients

    Why FDA should grant accelerated approval to eteplirsen for DMD

    Eteplirsen should receive accelerated approval for DMD because patients have earned the right to make the risk-benefit decision.

    Published on 5/2/2016
  • Figure: PK picture

    Endangered TIGER? PK picture FDA's PK analysis of rociletinib from Clovis Oncology Inc. (NASDAQ:CLVS) found that increasing concentrations of the compound did not correlate with increases in objective response …

    Published on 4/25/2016
  • Figure: Rociletinib's history

    Endangered TIGER? Rociletinib's history Clovis Oncology Inc. (NASDAQ:CLVS) has flip-flopped on the target dose for rociletinib to treat non-small cell lung cancer (NSCLC) and, according to FDA, the agency has …

    Published on 4/25/2016
  • Table: Rociletinib safety

    Endangered TIGER? Rociletinib safety The rate of serious adverse events increased with higher doses of rociletinib from Clovis Oncology Inc. (NASDAQ:CLVS). Of particular concern for FDA and its Oncologic Drugs …

    Published on 4/25/2016
  • Endangered TIGER?

    Handicapping rociletinib's future in NSCLC

    The emerging NSCLC landscape and Clovis' history of ignoring regulators could scuttle any future path forward for rociletinib.

    Published on 4/25/2016
  • Can 'Cures' be cured?

    Assessing the prospects for Senate's 21st Century Cures bill

    Any 21st Century Cures bill that can get through Congress will not come close to radically transforming drug discovery or dramatically accelerating cures.

    Published on 4/18/2016
  • Box: Biosimilars battles

    Can 'Cures' be cured? Biosimilars battles An arcane phrase inserted into part of the Senate Cures legislative package has set off alarm bells at some biosimilar companies and in the offices of the U.S. …

    Published on 4/18/2016
  • Box: Concentrating power at NIH

    Can 'Cures' be cured? Concentrating power at NIH The NIH provisions of the House and Senate's Cures legislation seek to make NIH more accountable, but they do this by aggregating more money and power in the hands …

    Published on 4/18/2016
  • Figure: 21st Century Cures

    Can 'Cures' be cured? 21st Century Cures The U.S. House of Representatives voted 344 -77 on July 10, 2015 to pass the 21st Century Cures Act (H.R. 6). Selected provisions of the 362-page bill follow, some of which…

    Published on 4/18/2016
  • Table: Senate innovation agenda

    Can 'Cures' be cured? Senate innovation agenda The Senate Health, Education, Labor and Pensions (HELP) Committee has passed a series of bills that Chair Lamar Alexander (R-Tenn.) intends to bundle into a single …

    Published on 4/18/2016
  • Box: Bristol's I/O network

    Survive and advance Bristol's I/O network In 2012, Bristol-Myers Squibb Co. established the International Immuno-Oncology Network (II-ON), a public-private partnership that includes 13 immuno-oncology universities…

    Published on 4/11/2016
  • Table: WHO criteria vs. irRC

    Survive and advance WHO criteria vs. irRC The Cancer Immunotherapy Consortium (CIC) developed the immune-related response criteria (irRC) to overcome shortcomings of WHO response criteria in describing responses …

    Published on 4/11/2016
  • Survive and advance

    Why industry, regulators are thinking about new endpoints for immuno-oncology

    Extended survival provided by immunotherapies means stakeholders are thinking about how to measure benefit for the next generation of immuno-oncology drugs.

    Published on 4/11/2016
  • Table: 2Q milestones

    Ample opportunity 2Q milestones Selected products with clinical or regulatory milestones expected in 2Q16. Source: BCIQ: BioCentury Online Intelligence Company Product Indication Event Milestone Ablynx N.V.…

    Published on 4/4/2016
  • None shall pass

    Biotech winners, losers in 1Q16

    None of the market cap bands finished 1Q16 in positive territory.

    Published on 4/4/2016
  • Figure: Among the bulls

    Fundamental reset Among the bulls The most recent biotech bull run, which followed the 2008-09 financial crisis, was the longest (333 weeks) and best performing (+543%) of the last five bull markets. Because of …

    Published on 4/4/2016
  • Figure: Biotech fund flows

    Fundamental reset Biotech fund flows Biotech funds saw net outflows of $3.2 billion in 1Q16, although there were signs of life in the quarter's final month. In 1Q15, net inflows were $4.1 billion. The March fund …

    Published on 4/4/2016
  • Table: Follow-on performance

    Fundamental reset Follow-on performance Follow-on activity tailed off in the last two months of the quarter, with about half of the 1Q offerings closing in February and March. For the quarter, $1.8 billion was …

    Published on 4/4/2016
  • Table: IPO performance

    Fundamental reset IPO performance While the number of IPOs dropped off last quarter, the group of newly public companies managed to post a median gain of 18%, led by a 149% rise in the market value of Korean …

    Published on 4/4/2016
  • Table: IPO queue

    Fundamental reset IPO queue At least seven companies have announced plans to go public since the start of 1Q16, bringing the IPO queue to at least 23. Unless noted, companies are seeking to list on NASDAQ. Filings…

    Published on 4/4/2016
  • Fundamental reset

    How biotech companies, bankers and buysiders will adjust to a new base in 2Q16

    With a floor nearly established and sector fundamentals unchanged, bio-bankers and buysiders agree it's a good time to put money to work.

    Published on 4/4/2016
  • Ample opportunity

    Investors' top names, milestones and meetings in 2Q16

    Event-driven buysiders have a full plate of late-stage milestones in 2Q16.

    Published on 4/4/2016

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993