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  • Table: Shrugging off IPRs

    Cut bait Shrugging off IPRs Activists and investors, including but not limited to Kyle Bass, have filed petitions with the U.S. Patent and Trademark Office for inter partes reviews (IPRs) of patents covering at …

    Published on 5/18/2015
  • Reforming IPR

    How BIO, PhRMA aim to get IPR reform into Senate's patent bill

    Influential senators are sympathetic to drug company complaints about the IPR process, but the House is less receptive to reforms.

    Published on 5/18/2015
  • Cut bait

    Why Congress may reform the inter partes review process on patents

    The threat from Kyle Bass' use of inter partes review has been exaggerated, but the publicity could lead to reforms.

    Published on 5/18/2015
  • Table: State of transparency

    Transparency scorecard State of transparency Lawmakers in five states have introduced transparency bills that would require companies to disclose R&D and SG&A expenses for certain drugs, along with those products'…

    Published on 5/11/2015
  • Transparency scorecard

    Why Mass. price transparency bill could succeed where others have failed

    Three drug price transparency bills have died on the vine, but the Massachusetts bill could pose the biggest challenge to the industry.

    Published on 5/11/2015
  • Shorter and fatter

    How 21st Century Cures draft boosts NIH budget, addresses FDA concerns

    New 21st Century Cures discussion draft gives NIH more money, reduces burden on FDA and eliminates proposed new drug exclusivities.

    Published on 5/4/2015
  • Box: An innovative fund

    Shorter and fatter An innovative fund The 21st Century Cures discussion draft released last week sidesteps standard congressional appropriations procedures to allocate $2 billion per year for five years to an NIH…

    Published on 5/4/2015
  • Speed trials

    How the Ebola outbreak sparked the fastest vaccine development efforts ever

    Collaborations to combat Ebola are developing vaccines at record speeds and could be creating a new model for responding to crises.

    Published on 4/27/2015
  • Figure: Record time

    Speed trials Record time Ad hoc collaborations among multinational pharma companies, government funding and research agencies, NGOs and philanthropic foundations have dramatically accelerated Ebola vaccine …

    Published on 4/27/2015
  • Learning from Ebola

    What lessons from Ebola can prepare society for other outbreaks

    The Ebola crisis should be an inflection point in global health and emerging infectious disease R&D.

    Published on 4/27/2015
  • Box: Getting pCR right

    FDA's rocket docket Getting pCR right Three years after publishing draft guidance on the use of pathologic complete response (pCR) as a surrogate endpoint for accelerated approval of neoadjuvant therapy for high-…

    Published on 4/20/2015
  • Box: Moving up in blood cancers

    FDA's rocket docket Moving up in blood cancers Hematologic cancer drug development has been so successful that FDA views it as a paradigm for the development of therapies for other kinds of cancer, Richard Pazdur,…

    Published on 4/20/2015
  • Box: Opdivo urgency

    FDA's rocket docket Opdivo urgency FDA pulled out all the stops to approve Bristol-Myers Squibb Co.'s Opdivo nivolumab to treat patients with metastatic squamous non-small cell lung cancer who have progressed on …

    Published on 4/20/2015
  • Box: Rapid biosimilars uptake

    FDA's rocket docket Rapid biosimilars uptake Richard Pazdur, director of the Office of Hematology and Oncology Drug Products in FDA's Center for Drug Evaluation and Research, predicts biosimilars will be adopted …

    Published on 4/20/2015
  • Box: Targeting ovarian cancer

    FDA's rocket docket Targeting ovarian cancer FDA's December 2014 approval of Lynparza olaparib, the first targeted therapy for ovarian cancer, could stimulate more drug development for ovarian cancer, according to…

    Published on 4/20/2015
  • Figure: Beating the clock

    FDA's rocket docket Beating the clock Since the start of 2013, FDA has approved 38 new or supplemental applications for cancer drugs. Twenty-three were approved at least two weeks before their PDUFA dates, 16 at …

    Published on 4/20/2015
  • Table: Trial designs

    FDA's rocket docket Trial designs FDA is speeding cancer drugs to market by allowing sponsors to use single-arm and open-label trials, and by approving products based on response rate and progression-free survival…

    Published on 4/20/2015
  • FDA's rocket docket

    Richard Pazdur on why FDA is racing to approve cancer drugs

    FDA's Richard Pazdur says scientific advances are producing better drugs, prompting the agency to race to approve them faster.

    Published on 4/20/2015
  • PRO progress

    How FDA, industry and patient community can increase number and quality of PROs

    FDA's proposed PRO compendium is a good start, but a precompetitive consortium and guidance could help accelerate patient-centric PROs.

    Published on 4/13/2015
  • Box: Two PRO system

    PRO progress Two PRO system PROs in the U.S. can be developed one of two ways — specifically for a given clinical candidate or independent of a specific drug development program via FDA's qualification process. …

    Published on 4/13/2015
  • Figure: Biotech fund flows

    Fundamental rally Biotech fund flows About $3.8 billion flowed into biotech funds last quarter, compared with $4.3 billion of net inflows in 1Q14. The BioCentury 100 gained 19% in 1Q15. The March fund flows figure…

    Published on 4/6/2015
  • Table: Follow-on performance

    Fundamental rally Follow-on performance Ninety-two biotechs raised $11.3 billion in 94 follow-ons in 1Q15, matching the total raised in the full year 2014. Excluding the $1.5 billion raised by Valeant …

    Published on 4/6/2015
  • Table: IPO performance

    Fundamental rally IPO performance Biotech companies raised $2 billion in 22 IPOs in 1Q15. The total is less than the $2.6 billion raised by 36 companies in 1Q14, but has only slowed slightly from 4Q14, when 24 …

    Published on 4/6/2015
  • Table: IPO queue

    Fundamental rally IPO queue At least 18 companies have announced plans to go public since the start of 1Q15, bringing the IPO queue to at least 32. Unless noted, companies are seeking to list on NASDAQ. Most …

    Published on 4/6/2015
  • Q is for quiet

    Investors look for cancer immunotherapy combination, gene therapy data in 2Q15

    With few big pending approvals, investors expect a quiet start to 2Q15 before a deluge of cancer immunotherapy combo data at ASCO.

    Published on 4/6/2015

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