Tag Archives: breakthrough designation

Best of the Blog: PharmExec's 10 Most Read Stories in 2013

Happy New Year! We at PharmExec are looking forward to a busy and hopefully fortuitous 2014. For our colleagues in the Northeast bracing for yet another snow storm – and for those of you with better short-term environmental prospects – here are the 10 most-read stories published on PharmExec‘s blog during 2013, in case you […]
Posted in Advertising, Biotech, Emerging Markets, Europe, FDA, Global, Guest Blog, healthcare, IP, Legal, Market Access, People, pricing, R&D, Regulatory, Strategy, Technology | Also tagged , , , , , , , , , , , , | Leave a comment

True Pharma Innovation Lies in Quality — not Quantity — of Approvals, say FDA analysts

We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market. The tally is closely watched as a sign of the state of biopharmaceutical innovation and the health of the pharmaceutical industry and biomedical research enterprise.
Posted in Biotech, FDA, Regulatory | Also tagged , , , , , , | Leave a comment

The List So Far: FDA Breakthrough Designations

With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July. With a separate senior management team […]
Posted in Biotech, FDA, Orphan Drugs, Regulatory | Also tagged , , , , , , , , , , , | Leave a comment

FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
Posted in FDA, Orphan Drugs, People, R&D, Regulatory, Strategy | Also tagged , , , , , , , , , , , , , , , , | Leave a comment
  • Categories

  • Meta