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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

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

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The year of the blockbuster

Together with the Genzyme unit of Sanofi, Alnylam filed for EU approval that same month. ... Filings elsewhere are also being prepared. A few additional therapies with blockbuster potential are also worth watching in 2018, especially if they receive
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
Bad news for Portola as CHMP considers Factor Xa drugs

Portola Pharmaceuticals’efforts to secure approval for its novel oral anticoagulant (NOAC) and reversal agent in Europe have hit another snag. ... In October 2015 the FDA granted accelerated approval to Boehringer's Praxbind (idarucizumab) reversal
Celixir cleared to start trial of stem cell therapy for heart failure

Replicating these results in larger global trials with, could make Heartcel eligible for conditional marketing authorisation in Europe and FDA accelerated approval in the US, ”said Celixir, which was previously known ... unit and completed the
Intercept hit hard as FDA issues Ocaliva safety notice

Intercept claimed an accelerated FDA approval for Ocaliva in May 2016 and followed that with an EMA green light in December.

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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

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

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

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

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

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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

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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....