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  • Table: Raising the bar

    Cancer drug scorecard Raising the bar While it develops a comprehensive scorecard for assetssing cancer drugs on the basis of benefit, toxicity and cost, the American Society of Clinical Oncology has put a stake in …

    Published on 3/24/2014
  • By (some of) the numbers

    How ICER concluded new HCV drugs Sovaldi, Olysio not worth their costs

    In its comparative effectiveness review, the not-for-profit ICER concluded the benefits of HCV drugs Sovaldi and Olysio did not match up to their costs. But the analyses did not capture all the benefits.

    Published on 3/24/2014
  • The price of success

    How payers hope to gain price leverage over new HCV drugs like Gilead's Sovaldi

    Payers are covering the new HCV drugs from Gilead and J&J, but they are already looking forward to new drugs expected to hit the market in the next 18 months in the hope they will be able to negotiate lower prices.

    Published on 3/24/2014
  • Table: HCV math

    The price of success HCV math While new HCV drugs from Gilead Sciences Inc. (NASDAQ:GILD) and Johnson & Johnson (NYSE:JNJ) are more expensive in some patient cohorts than regimens based on first-generation protease …

    Published on 3/24/2014
  • Table: On deck in HCV

    The price of success On deck in HCV Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) is the first interferon-free regimen and the most effective IFN-sparing regimen launched in the U.S. to date. If new …

    Published on 3/24/2014
  • Commentary: Don't go there

    Commentary: NICE is wrong-headed by toying with R&D-based reimbursement

    Orphan drug prices are raising legitimate concerns, but Alexion should not open Pandora's box by cooperating with NICE's notion that R&D costs can be used to determine value.

    Published on 3/17/2014
  • Slippery slope

    How NICE breaks new ground linking price of Soliris to Alexion's R&D investment

    NICE is breaking new ground by seeking to link the price of Soliris to Alexion's R&D investment; the question is whether the biotech will be able to reach a reimbursement deal without crossing that Rubicon.

    Published on 3/17/2014
  • Table: Interim HST criteria

    Slippery slope Interim HST criteria The National Institute for Health and Care Excellence's questions to Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) about R&D and manufacturing costs for Soliris eculizumab in …

    Published on 3/17/2014
  • Innovator capital rationing

    Actual financing data paint different picture of biotech's 'valley of death'

    Research-stage companies have raised 20% of all venture money since the financial meltdown. But capital rationing rewards a favored few, while efforts to fund very early translation remain a work in progress.

    Published on 3/10/2014
  • Figure: Early money

    Innovator capital rationing Early money Over the past five years, early stage companies in discovery or preclinical development have attracted about one-fifth of the total capital raised by private biotechs. …

    Published on 3/10/2014
  • Figure: VC rationing

    Innovator capital rationing VC rationing Of the $5.8 billion raised by all private research-stage companies in 2009-13, the top 10% (decile) raised $2.1 billion, or 37%. The average amount raised per company in the …

    Published on 3/10/2014
  • Table: Big bets

    Innovator capital rationing Big bets Eleven private research-stage companies raised at least $60 million in one or more financing rounds between 2009-13. All 11 have a platform for generating multiple drug …

    Published on 3/10/2014
  • Table: FVC comps

    Pause for breath FVC comps Both InterMune Inc. (NASDAQ:ITMN) and Boehringer Ingelheim GmbH have reported forced vital capacity (FVC) data for their idiopathic pulmonary fibrosis products that compares the proportion…

    Published on 3/3/2014
  • Pause for breath

    Why doctors both heartened, underwhelmed by InterMune's Esbriet data in IPF

    InterMune's ASCEND trial will likely satisfy FDA's request for clarity on Esbriet's efficacy and encourage ex-U.S. use, but the improvement is modest compared to unmet needs in idiopathic pulmonary fibrosis.

    Published on 3/3/2014
  • Dosing certainty

    EMA backs model from Novartis to identify safest, most effective Phase III dose

    EMA has put its official imprimatur on a new Phase II dosing model developed by Novartis that eliminates much of the guesswork around dose selection for Phase III.

    Published on 2/24/2014
  • Part D dysphoria

    How proposed changes to Medicare Part D could hurt patients, raise drug costs

    CMS's proposed changes to Medicare Part D will not only limit patient access to drugs, but also remove incentives to negotiate pharmacy discounts, and could have unforeseen knock-on effects on drug companies.

    Published on 2/17/2014
  • Box: Changing the equation

    Biosimilar schism Changing the equation According to data on biosimilar G-CSF products presented at last week's FTC meeting, biosimilars could change the cost equation for biologics without interchangeability. Mark…

    Published on 2/10/2014
  • Figure: Biosimilar elephant

    Biosimilar schism Biosimilar elephant When it comes to drug spending, Aetna Inc. (NYSE:AET) says the cost of innovator biologics is the elephant in the room. While specialty drugs accounted for just 1% of …

    Published on 2/10/2014
  • Biosimilar schism

    How biosimilars players have split over competing business models

    The growing ranks of biosimilars developers and manufacturers have split into two factions: those hoping for a generic business model, and those seeking higher entry barriers and higher profit margins.

    Published on 2/10/2014
  • Spies graduate

    How adaptive I-SPY 2 breast cancer study silenced critics

    I-SPY 2 has produced results with the rigor of an industry-run trial and is now attracting more interest from companies, including those that want to develop drugs for neoadjuvant breast cancer as the lead indication.

    Published on 2/3/2014
  • Box: Spies multiply

    Spies graduate Spies multiply Some of the lessons from the I-SPY program are already being exported to other indications. The Phase II BATTLE-2 trial in non-small cell lung cancer (NSCLC) is testing four targeted …

    Published on 2/3/2014
  • Box: Under new management

    Spies graduate Under new management I-SPY 3 will be run by eXcelerate Research Inc., a for-profit spinout of the not-for-profit Quantum Leap Healthcare Collaborative. Quantum Leap is an incubator for discoveries …

    Published on 2/3/2014
  • Table: I-SPY 2 scorecard

    Spies graduate I-SPY 2 scorecard Since the adaptive Phase II I-SPY 2 study began in 2010, two of the three original compounds have graduated, and five more have been added. Compounds graduate or are dropped based on…

    Published on 2/3/2014
  • Box: Access to China

    Taiwan's biotech boom Access to China Companies and VCs who spoke to BioCentury think Taiwan's cultural and physical proximity to China will provide access to the mainland's population of over 1 billion. "Taiwan …

    Published on 1/27/2014
  • Box: Trials in Taiwan

    Taiwan's biotech boom Trials in Taiwan Taiwan's emerging biopharma sector is supported by an infrastructure and a regulatory environment that allow companies to efficiently conduct clinical trials. "Many clinical …

    Published on 1/27/2014

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