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  • Table: TAPUR vs. MED-C

    Targeting access TAPUR vs. MED-C The American Society of Clinical Oncology and the Molecular Evidence Development Consortium (MED-C) are launching registries to collect evidence about biomarker-based off-label use…

    Published on 12/22/2014
  • Figure: Legal complexity

    Momenta moving on Legal complexity Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) had hoped its platform for characterizing complex molecules would create IP and know-how that would protect a portfolio of complex …

    Published on 12/15/2014
  • Momenta moving on

    Why Momenta abandoning complex generics in favor of novel drugs and biosimilars

    Momenta unveils its novel drug, biosimilar strategy after nine years of legal and regulatory setbacks in complex generics.

    Published on 12/15/2014
  • Pricing gene therapies

    Lessons from Glybera on alternative pricing models for gene therapies

    Disease-specific issues stymied annuity pricing for uniQure's Glybera, but the model still could work for gene therapies in other diseases.

    Published on 12/8/2014

    Merck's IMPROVE-IT bolsters case for PCSK9 inhibitors, but sets bar for outcomes

    Merck's IMPROVE-IT shows nonstatin LDL-lowering improves CV outcomes, but also sets outcomes hurdles for PCSK9 agents poised in the wings.

    Published on 11/24/2014
  • Poste a pourvoir

    Board mandates mean shoring up Lantus losses won't be easy for Sanofi CEO

    Sanofi's new CEO will have a hard row to hoe to offset Lantus declines, as the board has taken easy solutions off the table.

    Published on 11/17/2014
  • Figure: Pipeline by source

    Poste à pourvoir Pipeline by source During his tenure as CEO of Sanofi (Euronext:SAN; NYSE:SNY), Chris Viehbacher and President of Global R&D Elias Zerhouni pruned the pharma's pipeline of uncompetitive programs and…

    Published on 11/17/2014
  • Figure: Sanofi share performance

    Poste à pourvoir Sanofi share performance Shares of Sanofi (Euronext:SAN; NYSE:SNY) have gained 129% since Chris Viehbacher became CEO, after adjusting for dividends. This compares to a 205% gain for an equal price-…

    Published on 11/17/2014
  • Table: Filling in for Lantus

    Poste à pourvoir Filling in for Lantus The six drugs Sanofi (Euronext:SAN; NYSE:SNY) plans to launch in 2015-16 could make up for part of the recent and unexpected shortfall in Lantus insulin glargine sales, but …

    Published on 11/17/2014
  • Table: Sanofi comps

    Poste à pourvoir Sanofi comps During former CEO Chris Viehbacher's tenure at Sanofi (Euronext:SAN; NYSE:SNY), which began in December 2008, the pharma lagged most of its peers in EPS growth. EPS has posted an …

    Published on 11/17/2014
  • Lantus limbo

    What Sanofi's Lantus rebates mean for new insulin candidates launching in 2015

    Lantus rebates could spell reimbursement pressure for new insulin products Sanofi and others will be launching in 2015 and 2016.

    Published on 11/17/2014
  • Republican reset

    How the Republican wave resets expectations for revamping FDA

    The Republican wave has boosted the chances for 21st Century Cures legislation as a vehicle for reforms once reserved for PDUFA.

    Published on 11/10/2014
  • Translation in Asia

    How J&J's new Asia Pacific Innovation Center in Shanghai will access innovation

    J&J's new Asia Pacific Innovation Center will initially do more translation of academic work than the other three centers.

    Published on 11/3/2014
  • Figure: Deals by center

    Translation in Asia Deals by center The new Asia Pacific Innovation Center in Shanghai is the fourth and final in a two-year-old initiative aimed at increasing the number and speed of early stage deals by Johnson & …

    Published on 11/3/2014
  • Figure: Innovation by segment

    Translation in Asia Innovation by segment Dong Wu, head of Johnson & Johnson's (NYSE:JNJ) new Asia Pacific Innovation Center, comes from the consumer products division, which should help all four centers with …

    Published on 11/3/2014
  • Box: Other gripes

    Amgen on notice Other gripes Among activist investor Third Point LLC's gripes with Amgen Inc. are the biotech's SG&A spending and its 2013 acquisition of Onyx Pharmaceuticals Inc. Third Point noted that Amgen …

    Published on 10/27/2014
  • Figure: Amgen R&D Comps

    Amgen on notice Amgen R&D comps Over the past 10 years, Amgen Inc. (NASDAQ:AMGN) has spent $29.3 billion on R&D - 1.6x the combined spending by Biogen Idec Inc. (NASDAQ:BIIB) and Gilead Sciences Inc. (NASDAQ:GILD)…

    Published on 10/27/2014
  • Figure: Amgen SG&A comps

    Amgen on notice Amgen SG&A comps Amgen Inc. (NASDAQ:AMGN) has spent $37.4 billion on SG&A over the past 10 years, or 25% of its revenues. This compares to $9.4 billion (23%), for Biogen Idec Inc. (NASDAQ:BIIB) and $…

    Published on 10/27/2014
  • Amgen on notice

    How splitting up doesn't address Amgen's struggles creating value-driving assets

    Third Point says splitting Amgen will unleash value, but the portfolio shows the biotech is hard pressed to advance value-driving assets.

    Published on 10/27/2014
  • Box: A rising tide

    Walking the toll road A rising tide In addition to an improved understanding of TLR biology, advances in cancer immunotherapy have opened up the possibility of TLR agonist combinations. Axel Hoos, VP of oncology R&…

    Published on 10/20/2014
  • Table: Endosomal TLR agonists

    Walking the toll road Endosomal TLR agonists At least 14 endosomal TLR agonists are in the clinic. Source: BCIQ: BioCentury Online Intelligence Company Product TLR Lead indication Status Dynavax Technologies …

    Published on 10/20/2014
  • Table: Endosomal TLR antagonists

    Walking the toll road Endosomal TLR antagonists At least three products in development antagonize endosomal TLRs. Source: BCIQ: BioCentury Online Intelligence Company Product TLR Lead indication Status Dynavax…

    Published on 10/20/2014
  • Table: Surface TLR agonists

    Walking the toll road Surface TLR agonists At least four products that agonize cell surface TLRs are in the clinic. (A) Entolimod is being developed to treat acute radiation syndrome under FDA's Animal Rule, which …

    Published on 10/20/2014
  • Table: Surface TLR antagonists

    Walking the toll road Surface TLR antagonists At least three products that antagonize cell surface TLRs are in the clinic. Two of the three, OPN-305 from Opsona Therapeutics Ltd., and NI-0101 from Novimmune S.A., …

    Published on 10/20/2014
  • Walking the toll road

    Why investors have started placing bets on toll-like receptors again

    Better understanding of biology and new delivery approaches are refreshing interest in TLR modulators.

    Published on 10/20/2014

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