Please login to the form below

Not currently logged in
Email:
Password:

priority review

This page shows the latest priority review news and features for those working in and with pharma, biotech and healthcare.

FDA starts priority review of BMS Opdivo/Yervoy in first-line NSCLC

FDA starts priority review of BMS Opdivo/Yervoy in first-line NSCLC

The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) in combination with BMS’ low-dose CTLA4 inhibitor Yervoy (ipilimumab) in previously-untreated NSCLC patients whose tumours ... The FDA’s review will focus on the CheckMate-227

Latest news

More from news
Approximately 6 fully matching, plus 296 partially matching documents found.

Latest Intelligence

  • Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019 Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

    One Japanese Sakigake designation. One Chinese Priority Review. Interestingly, this year’s list contains no cancer drugs. ... Upadacitinib was filed for approval in the US and EU in December 2018 and accepted for US Priority Review in February 2019.

  • AstraZeneca: building a new ‘open innovation’ pharma company AstraZeneca: building a new ‘open innovation’ pharma company

    Lastly, AZ has also gained three Breakthrough Therapy Designations (including two Orphan Drug Designations) and six additional Priority Review Designations.

  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA)’s Priority Review pathway, ... This means the out-of-pocket cost for healthcare has fallen,

  • Pharma deals continue to slide Pharma deals continue to slide

    Gilead has been trying to diversify away from anti-viral therapies into oncology and Kite is a good fit with its CAR-T technology and a lead product in priority review ... Headline. $m. Kite (US). Gilead (US). Company acquisition. CAR-T technology with

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. ... In 2016 special approval pathways and designations like Fast Track, Breakthrough, Accelerated

More from intelligence
Approximately 0 fully matching, plus 12 partially matching documents found.

Latest from PMHub

More from PMHub
Approximately 0 fully matching, plus 2 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Red Health

Red Health was formed in 2007 to bring something fresh to the healthcare PR world. Our approach was simple –...

Latest intelligence

How do companies prepare for reimbursement?
Valid Insight explore how to optimise your market access strategy during new product development, how to address payer concerns and prepare for reimbursement....
EHR clinical trials
Integrating electronic health records into clinical trials
How organisations are working to realise the research potential of EHRs...
Mike Elliott Gilead
Keeping up the fight against HIV and using the lessons to tackle other threats
Danny Buckland interviews Gilead’s Mike Elliott...

Infographics