Please login to the form below

Not currently logged in
Email:
Password:

accelerated approval

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

AbbVie slumps on trial results for would-be blockbuster Rova-T

AbbVie slumps on trial results for would-be blockbuster Rova-T

Now the company has said it won’t be able to file for accelerated approval after discussions with the FDA about “the magnitude of the effect across multiple parameters”in the

Latest news

More from news
Approximately 5 fully matching, plus 124 partially matching documents found.

Latest Intelligence

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

    During 2016, special approval procedures like conditional and accelerated approval pathways were issued for seven of the new approvals in the EU, the majority in oncology and for orphan diseases. ... In 2016 special approval pathways and designations

  • Curbing the rise of drug resistance Curbing the rise of drug resistance

    Microbes have an extraordinary capacity for developing resistance, accelerated by the over-use of anti-microbials in clinical and agricultural practice. ... Therapeutic areas such as oncology have already enjoyed accelerated approval times to jump

  • Oncology drugs under AMNOG: part two Oncology drugs under AMNOG: part two

    of Xalkori, below - the drug can achieve accelerated approval on the basis of an interim analysis or phase II data before OS is established. ... the tumour shows an excess of a particular biomarker, accelerated approval meant that no clinically

  • Small diseases need big picture communications Small diseases need big picture communications

    Four steps to success. 1. Start early . Whereas a traditional communications strategy might start to gain momentum as phase III trials begin, the accelerated development and approval processes of orphan drugs ... Compressed lead-in times. Accelerated

  • Getting UK market access right Getting UK market access right

    But market access starts before product approval and activities should first be initiated during the clinical trial phase. ... Gaining early understanding of stakeholder requirements and their impact on product development and market launch can help

More from intelligence
Approximately 0 fully matching, plus 6 partially matching documents found.

Latest from PMHub

  • A stumble, but not a fall – what’s next for Opdivo?

    The  immuno-oncology treatment won an accelerated FDA approval for metastatic melanoma in December 2014, and has since proved to be a thriving sensation. ... Rubbing salt into BMS’ s wounds, Merck's  Keytruda snagged a new FDA approval in

More from PMHub
Approximately 0 fully matching, plus 1 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
CACTUS

Founded in 2002, Cactus Communications is a fully integrated, global scholarly communications company with offices in Japan, South Korea, India,...

Latest intelligence

No incentive for a cure
The paradox of ‘cost-effective but unaffordable’ life-saving medicines...
Why heading online for scientific meetings can yield greater HCP engagement
Modern conferencing methods, with enhanced digital information transfers, offer unique opportunities for greater HCP engagement....
The threat of antimicrobial resistance
Why this issue is such a fundamental challenge...

Infographics