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  • LDT blurred Lines

    FDA has set the playing field for regulatory, legislative endgame on LDTs

    FDA's planned draft guidance on lab developed test sets up the playing field for the regulatory and legislative endgame on LDTs.

    Published on 8/11/2014
  • Table: FDA-approved companion diagnostics

    LDT blurred Lines FDA-approved companion diagnostics FDA has approved 19 companion diagnostics for 13 drugs. Stakeholders contacted by BioCentury expressed concern that the agency's resources could be overwhelmed …

    Published on 8/11/2014
  • FDA's quality crusade

    FDA plans sea change in regulation of drug manufacturing quality, innovation

    FDA says its Office of Pharmaceutical Quality is a 'game changer' that will spur manufacturers to innovate and compete on quality.

    Published on 8/4/2014
  • Figure: Beyond batch

    FDA's Quality Crusade Beyond batch: Continuous manufacturing integrates all steps of production - from start to finish - into a single process in one location. Source: Novartis AG

    Published on 8/4/2014
  • Partnering Afrezza

    What challenges await potential partner for MannKind's Afrezza inhaled insulin

    Its inhaled insulin approved, MannKind now must persuade any marketing partner to invest in answering a new host of questions.

    Published on 7/28/2014
  • Figure: Diminished dependency

    AbbVie's plan B Diminished Dependency Based on 2013 figures, the acquisition of Shire plc (LSE:SHP; NASDAQ:SHPG) increases AbbVie Inc. (NYSE:ABBV) revenues by 28%, to $24 billion from $18.8 billion, while lessening …

    Published on 7/21/2014
  • Figure: Pipeline diversification

    AbbVie's plan B Pipeline diversification AbbVie Inc.'s (NYSE:ABBV) pending acquisition of Shire plc (LSE:SHP; NASDAQ:SHPG) would add nine Phase II and Phase III compounds across six different disease areas, …

    Published on 7/21/2014
  • AbbVie's plan B

    What AbbVie really needs from Shire besides inversion benefits

    Given escalating competition in HCV and MS, Shire could be AbbVie's plan B for growth after the inversion debate is over and forgotten.

    Published on 7/21/2014
  • 3Q14 Financial Markets Preview: Discerning optimism

    Biotech investors: bottom hit but will be selective on IPOs, small caps in 3Q14

    Buysiders hope correction has provided a floor for a biotech recovery, with investors being selective on IPOs and small caps in 2H14.

    Published on 7/14/2014
  • 3Q14 Financial Markets Preview: Summer lull

    Biotech investors expect quiet 3Q14, position portfolios for larger events in 4Q

    With some notable exceptions, investors anticipate a quiet 3Q14 in terms of milestones and are positioning their portfolios for larger events later in the year.

    Published on 7/14/2014
  • Figure: Healthcare/biotech fund flows

    Discerning optimism Healthcare/biotech fund flows About $6.8 billion exited healthcare/biotech funds last quarter. But net funds are still up $5.3 billion for the year, thanks to inflows of $12.1 billion in 1Q14. …

    Published on 7/14/2014
  • Table: Follow-on performance

    Discerning optimism Follow-on performance Biotechs have raised $7.2 billion via 95 follow-ons in 2014, averaging $75.8 million per deal. This compares with $6.5 billion raised in 65 deals in 1H13, an average of $100…

    Published on 7/14/2014
  • Table: IPO performance

    Discerning optimism IPO performance Fifty-nine companies raised $3.9 billion via IPOs in 1H14, compared to 26 that raised $1.5 billion in 1H13. The 1H14 group is up a median of 6% from their initial valuations, with…

    Published on 7/14/2014
  • Table: IPO queue

    Discerning optimism IPO queue A rush of 30 IPO filings since the start of 2Q14 has brought the queue to at least 41. Additionally, in 1Q14, Chinese genomics company BGI Inc. has said it is "working on" an IPO. …

    Published on 7/14/2014
  • Figure: London vs. Europe

    Large and in charge London vs. Europe The BioCentury Europe index gained 13% in 2Q14, while the BioCentury London index gained 8%. Twelve of 19 continental European biotechs in the market cap-weighted European index…

    Published on 7/14/2014
  • Figure: Price-to-earnings: BT vs RX

    Large and in charge Price-to-earnings: BT vs RX The gap between P/Es for biotech and big pharma contracted last quarter, with biotech's multiple closing at 1.4x that of big pharma. The last time the gap was that …

    Published on 7/14/2014
  • Figure: Results by market cap

    Large and in charge Results by market cap Only one market cap segment - biotechs valued above $5 billion - posted a gain last quarter. That group was up a median of 4%, led by a 59% gain by Shire plc (LSE:SHP; …

    Published on 7/14/2014
  • Table: 2Q approvals and 2Q setbacks

    Large and in charge 2Q approvals Selected second quarter approvals. Company Approval Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) FDA grants full approval to Soliris eculizumab to treat atypical hemolytic uremic …

    Published on 7/14/2014
  • Table: Index performance

    Large and in charge Index performance The BioCentury 100 index rose only 2% in 2Q14, while the NYSE Arca Biotechnology (BTK) and NASDAQ Biotechnology (NBI) indices both gained more than 7%. The discrepancy is …

    Published on 7/14/2014
  • Table: Restructuring watch

    Large and in charge Restructuring watch Biotech employee reductions continued at record low levels in 2Q14, when at least four companies reduced their workforces compared to at least 13 in the same period last year.…

    Published on 7/14/2014
  • Table: 2H milestones

    Summer lull 2H milestones Selected products with Phase III or regulatory milestones expected in 2H14. (A) Uses PEGylation technology from Nektar Therapeutics (NASDAQ:NKTR); (B) Lymphoseek is already approved for …

    Published on 7/14/2014
  • 2Q Stock Wrap-Up: Large and in charge

    Winners, losers in biotech stock tiers in 2Q14

    Following a first quarter that saw all market cap segments gain ground, only the large caps finished in the black in 2Q14.

    Published on 7/14/2014
  • States' rights

    As right-to-try landscape expands in U.S., so does debate on laws' effect

    State right-to-try laws reflect deep dissatisfaction with the pace of drug development, but industry and some patient advocates don't think they'll work.

    Published on 6/30/2014
  • Box: Neuralstem's plans

    States' rights Neuralstem's plans At least one company has announced its intention to make a product available to patients under state right-to-try laws. Neuralstem Inc. President and CEO Richard Garr told …

    Published on 6/30/2014
  • Accelerating adaptation

    Why EMA has been able to get adaptive licensing off the ground ahead of FDA

    EMA's adaptive licensing pilot places Europe ahead of the U.S., largely because stricter controls on prescribing in Europe preclude the concerns that have stalled FDA's special medical use pathway.

    Published on 6/23/2014

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