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.

Daily brief: Global Blood confident of sickle cell success, Breathalyser wins engineering award, Swiss biotech raises funds

Daily brief: Global Blood confident of sickle cell success, Breathalyser wins engineering award, Swiss biotech raises funds

The company held a meeting with the FDA earlier this week to discuss its data, and the group is confident it is robust enough to gain accelerated regulatory approval. ... Love also said he believed that the treatment meets the standard for accelerated

Latest news

More from news
Approximately 5 fully matching, plus 126 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
Sciterion

Sciterion is an award winning specialist healthcare communications consultancy within the Havas Health network of companies. We exist to make...

Latest intelligence

Developing advocacy in the pharmaceutical industry.
The importance of advocacy programmes...
GDPR and events. What does the pharma industry need to know?
Many people in the pharma industry still aren’t following the rules set out by the GDPR when it comes to running events and attending tradeshows. But with eye-watering fines for...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....

Infographics