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  • ASCO's honest broker

    ASCO off-label access program could be model for compassionate access

    ASCO is developing an initiative to facilitate off-label access to targeted cancer therapies. If successful, the system could serve as a model for third-party bodies that could manage early access to experimental …

    Published on 4/21/2014
  • Unlocking cancer data

    How biopharma buy-in boosts Project Data Sphere in cancer data-sharing

    With upfront buy-in from executive leadership in industry, academia and non-profits, Project Data Sphere for cancer could overcome challenges that have slowed other data-sharing efforts.

    Published on 4/14/2014
  • Blazing a path in data sharing

    Project Data Sphere in cancer learned from Critical Path's data-sharing in AD

    The cancer data-sharing group Project Data Sphere met with the Critical Path Institute to learn from the institute's data-sharing initiatives for neurodegenerative diseases.

    Published on 4/14/2014
  • Table: Data details

    Unlocking cancer data Data details Project Data Sphere LLC already has data from nine clinical trials available for use on its website, and expects to add data from 20 more "soon." The current data sets include only…

    Published on 4/14/2014
  • Table: Sphere of influence

    Unlocking cancer data Sphere of influence The officers and executive committee members for Project Data Sphere LLC are leaders from industry, academic institutions and not-for-profit groups. Upfront buy-in from …

    Published on 4/14/2014
  • 2Q14 Financial Markets Preview: Minor adjustment

    2Q14 stocks: Why buysiders expect biotech's run to continue

    Buysiders believe the biotech pullback has bottomed out, and with large cap biotechs looking cheap, hope investors put their cash back into the sector and keep the markets accessible for financings this quarter.

    Published on 4/7/2014
  • 2Q14 Financial Markets Preview: Big buying opps

    Biotech 2Q14: Buysiders like big caps; are becoming wary of small cap prices

    A steady flow of positive news could play a critical role in reversing the recent outflow of investors from biotech, according to buysiders, who are watching for news from Gilead, Vertex and ASCO attendees

    Published on 4/7/2014
  • 1Q Stock Wrap-Up: Small but mighty

    Microcaps gain double-digits in 1Q14 as all biotech segments finish in black

    Despite biotech's pullback at the end, all five market cap segments finished 1Q14 in positive territory, with a double-digit gain by microcaps setting the pace.

    Published on 4/7/2014
  • Figure: Bumps in the road

    Minor adjustment Bumps in the road Since the start of 2009, the BioCentury 100 has gained 26% per year on average and has gone through five corrections of at least 10%, one of which exceeded 20%. The price-weighted …

    Published on 4/7/2014
  • Figure: Healthcare/biotech fund flows

    Minor adjustment Healthcare/biotech fund flows Healthcare/biotech funds pulled in $11.2 billion during 1Q14 vs. net inflows of $4.7 billion in 1Q13. Fund flows for March were weaker than January and February, as the…

    Published on 4/7/2014
  • Table: Follow-on performance

    Minor adjustment Follow-on performance Sixty-one biotechs raised $4.7 billion in follow-ons in 1Q14, doubling the $2.3 billion raised by 32 companies in 1Q13. Follow-ons last quarter were down a median of 2% from …

    Published on 4/7/2014
  • Table: IPO performance

    Minor adjustment IPO performance Thirty-six biotechs priced IPOs in 1Q14, raising over $2.6 billion. That's two thirds as much as the $3.8 billion raised in all of 2013. The 1Q14 IPO class is up a median of 25% from…

    Published on 4/7/2014
  • Table: IPO queue

    Minor adjustment IPO queue At least 23 companies have proposed IPOs, including 18 since the start of the year. Additionally, Chinese genomics company BGI Inc. has said it is "working on" an IPO. Unless noted, …

    Published on 4/7/2014
  • Figure: London vs. Europe

    Small but mighty London vs. Europe The BioCentury Europe index gained 4% in 1Q14, while the BioCentury London index declined by 2%. Fifteen of 19 continental European biotechs in the market cap-weighted BC Europe …

    Published on 4/7/2014
  • Figure: Price-to-earnings: BT vs RX

    Small but mighty Price-to-earnings: BT vs RX The average biotech P/E ended the quarter at 27.4, about 1.6x big pharma's average P/E of 17.3. But biotech's average multiple drops to 22.2, only 1.28x that of big …

    Published on 4/7/2014
  • Figure: Results by market cap

    Small but mighty Results by market cap The two smallest market cap segments - companies valued below $200 million and those valued at $200-$499 million - each rose more than 5% last quarter on a deluge of IPOs. In …

    Published on 4/7/2014
  • Table: 1Q approvals and 1Q setbacks

    Small but mighty 1Q approvals Selected first quarter approvals. Company Approval Anika Therapeutics Inc. (NASDAQ:ANIK)/Johnson & Johnson (NYSE:JNJ) FDA approves Monovisc to treat osteoarthritis of the knee …

    Published on 4/7/2014
  • Table: 2Q milestones

    Small but mighty 2Q milestones Selected products with Phase III or regulatory milestones expected in 2Q14. Source: BCIQ: BioCentury Online Intelligence Company Product Indication Event Milestone AcelRx …

    Published on 4/7/2014
  • Table: Index performance

    Small but mighty Index performance The BioCentury 100, NYSE Arca Biotechnology (BTK) and NASDAQ Biotechnology (NBI) were not in lockstep in 1Q due to differences in the indices' makeup. The BC100 and BTK rose 10% …

    Published on 4/7/2014
  • Table: Restructuring watch

    Small but mighty Restructuring watch Only two companies reported workforce reductions in the first quarter compared to at least 10 in the same period last year. This is the smallest number since BioCentury started …

    Published on 4/7/2014
  • Commentary: The equitable pathway

    BioCentury checklist for an equitable compassionate access system

    It is possible to identify basic principles that should underlie a transparent system for reviewing compassionate use requests, no matter who does the assessment.

    Published on 3/31/2014
  • Viral crossroads

    Hardy case shows flaws in compassionate use system, provides catalyst for change

    The Josh Hardy case highlights the inadequacy of the process for deciding when to grant access to experimental medicines outside of clinical trials. It also may be a catalyst for change.

    Published on 3/31/2014
  • Josh Hardy chronicles

    How Chimerix, FDA grappled with providing compassionate access to Josh Hardy

    While social media users may be claiming the credit, in the end Chimerix and FDA had to clear a way to provide brincidofovir to a handful of patients while opening a door for broader access via a bigger trial.

    Published on 3/31/2014
  • Figure: Decision tree for compassionate use

    The equitable pathway Decision tree for compassionate use The principles guiding decisions about compassionate access should be the same regardless of the details of the individual request, and no matter who makes …

    Published on 3/31/2014
  • Figure: Expanded access scorecard

    Viral crossroads Expanded access scorecard FDA acts on requests for expanded access when submitted by a sponsor or by a third party with the sponsor's support. The agency approved 99.4% of expanded access …

    Published on 3/31/2014

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