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  • Lorcaserin's niche

    Despite potential REMS hurdles, Arena's lorcaserin could fill niche in obesity

    Arena's lorcaserin could carve out a niche in obesity despite limited efficacy and potential hurdles to use, including an FDA committee's call for baseline and annual echocardiograms.

    Published on 5/14/2012
  • Breathing easier for now

    Actelion's agenda after Macitentan's success in make-or-break Phase III for PAH

    Actelion's agenda after Macitentan's success in make-or-break Phase III for PAH

    Published on 5/7/2012
  • With or without you

    Gilead, BMS may go separate ways in HCV despite 100% SVR rate in Phase IIa

    While combining BMS's daclatasvir and Gilead's GS-7977 produced a 100% SVR rate in a Phase II study, the two may eschew the opportunity to be first with a pan-genotypic HCV therapy. A split would increase technology …

    Published on 4/30/2012
  • Table: HGS pipeline

    A couple of bucks more HGS pipeline Like its marketed lupus treatment Benlysta belimumab, many of the clinical programs at Human Genome Sciences Inc. (NASDAQ:HGSI) are partnered with suitor GlaxoSmithKline plc (LSE:…

    Published on 4/23/2012
  • A couple of bucks more

    Evaluating three options for Human Genome in wake of takeout bid by GSK

    Holding out for more money from GSK seems the most likely scenario for Human Genome Sciences, given the small value ascribed to the biotech's assets outside the partnership and the faint hope for a white knight.

    Published on 4/23/2012
  • Tear down that wall

    How JOBS Act rules could make it easier for small biotechs to go public

    The JOBS Act could allow small biotechs to access greater numbers of investors and revive analyst coverage. But the path forward won't be clear until the SEC and FINRA actually write the rules of the road.

    Published on 4/16/2012
  • Box: Two birds, one trial

    A longer weight Two birds, one trial Novo Nordisk A/S is developing diabetes drug Victoza liraglutide for obesity and is hopeful that its fully enrolled cardiovascular outcomes trial in diabetics will be enough to …

    Published on 4/9/2012
  • Table: Doubling up

    A longer weight Doubling up Obesity companies may need to double the size of their Phase II and III programs if FDA follows a panel's recommendation to hold obesity drugs to the same standard as diabetes drugs in …

    Published on 4/9/2012
  • Slimming development

    How FDA could speed development drugs to target subgroups of obese patients

    Two measures being developed in Washington could offset the burden of extensive CV risk assessment of drugs to treat obesity. Both could shift the paradigm toward subgroups and away the broader population.

    Published on 4/9/2012
  • A longer weight

    Why obesity drug cardiovascular trials could add $100M, 2 years to FDA pathway

    FDA may soon approve the first new obesity drug in more than a decade, but the prospect of new cardiovascular studies prior to approval could mean next-generation compounds won't be available for 5-6 years.

    Published on 4/9/2012
  • Doubling down

    1Q12 stocks: At least one biotech doubled value in every market cap group

    Biotech investors not only lifted valuations across the board in 1Q, but also more than doubled the market caps of 20 biotechs.

    Published on 4/2/2012
  • Some like it hot

    2Q12 biotech stocks: Rally may last a bit longer despite signs of a top

    Buysiders and bankers expect the biotech rally to continue into 2Q, especially in the smaller cap names. But increasing doubts about the back half of 2012 mean companies should be raising money now.

    Published on 4/2/2012
  • Thinking small again

    Biotech 2Q12 buyside picks: Smaller caps, 1Q performers, European names

    Buysiders are tipping a plethora of small and micro-caps as performance in these groups finally picked up in 1Q. Investors also continue to like some of the top 1Q winners across market caps.

    Published on 4/2/2012
  • Figure: London vs Europe

    Doubling down London vs Europe The BioCentury Europe index was up 10% last quarter, while the BioCentury London gained 3%. Of 19 companies in the market cap-weighted continental European benchmark, 15 ended in …

    Published on 4/2/2012
  • Figure: Price-to-earnings: BT vs RX

    Doubling down Price-to-earnings: BT vs RX Biotech's average P/E is up 32% to 19.3 from 14.6 a year ago. The group is led by Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) and Biogen Idec Inc. (NASDAQ:BIIB), with P/Es of…

    Published on 4/2/2012
  • Table: 1Q approvals

    Doubling down 1Q approvals Selected first quarter product approvals. Company Approval Affymax Inc. (NASDAQ:AFFY)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) FDA approves once-monthly Omontys peginesatide to …

    Published on 4/2/2012
  • Table: 2Q12 milestones

    Doubling down 2Q12 milestones At least 66 Phase III or regulatory milestones are expected in 2Q12. (A) Assumes 10-month review; Source: BCIQ: BioCentury Online Intelligence Company Product Indication Event …

    Published on 4/2/2012
  • Table: Index performance

    Doubling down Index performance The BioCentury 100 Index jumped 17% on the quarter, led by obesity companies Orexigen Therapeutics Inc. (NASDAQ:OREX) and Vivus Inc. (NASDAQ:VVUS), which were up 155% and 129%, …

    Published on 4/2/2012
  • Table: Restructuring watch

    Doubling down Restructuring watch At least nine companies reduced their workforces in 1Q12 compared to at least 15 in the same period last year. All cash and operating loss figures in $M. (A) 12-month net loss; …

    Published on 4/2/2012
  • Figure: Healthcare/biotech fund flows

    Some like it hot Healthcare/biotech fund flows About $780 million have flowed into healthcare/biotech funds in 2012, with more than $1.5 billion flowing into these funds in January and $801 million exiting in …

    Published on 4/2/2012
  • Figure: Inflection point

    Some like it hot Inflection point While the BioCentury 100 and NASDAQ Biotechnology indices have gained 37% and 46%, respectively, since the bottom of the market in August 2011, both indices have been flat since the…

    Published on 4/2/2012
  • Figure: Raised by market cap

    Some like it hot Raised by market cap Debt deals by two companies valued above $5 billion - Gilead Sciences Inc. (NASDAQ:GILD) and Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) - accounted for 38%…

    Published on 4/2/2012
  • Figure: Results by market cap

    Some like it hot Results by market cap All market cap tiers gained more than 11% last quarter. The aggregate market value for the entire group of 574 companies gained $72 billion (15%) to $552 billion. The best …

    Published on 4/2/2012
  • Table: Follow-on performance

    Some like it hot Follow-on performance Thirty-four companies raised $2 billion in follow-ons in 1Q12, up from 29 companies that raised $1.7 billion in 1Q11. The group is up a median of 2%, led by a 110% increase in …

    Published on 4/2/2012
  • Table: IPO performance

    Some like it hot IPO performance Seven biotechs raised $454.4 million via IPOs in 1Q12. This compares to 7 IPOs that raised $325.2 million in 1Q11. The 1Q12 group is up a median of 7% for the quarter, led by …

    Published on 4/2/2012

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