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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.
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
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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
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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
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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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AZ buoyed by latest lung cancer data at ESMO
FDA, it could be pitching at a potential approval in the first half of 2018. ... AZ was awarded accelerated approval by the FDA for Imfinzi in previously-treated patients with advanced bladder cancer in May, pulling in just $1m in sales in the first half
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BMS data add to checkpoint inhibitor combo confusion
significance. The combination of Opdivo and Yervoy has already shown its worth in melanoma, with BMS claiming approval for the pairing in 2015 on the back of data from the ... BMS meanwhile said earlier this year that it wouldn't be able to file for
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Latest Intelligence
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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
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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
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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
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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
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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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Latest from PMHub
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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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Founded in 2002, Cactus Communications is a fully integrated, global scholarly communications company with offices in Japan, South Korea, India,...
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