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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.

Alnylam seeks fast-track filing with biomarker data

FDA. , and hope to file at or around year-end 2018, with the hope of securing a fast track approval. ... FDA. to discuss the results and the overall benefit-risk profile for a potential NDA submission at or around year-end in support of an accelerated

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Daily Brief: EU agencies brace for No Deal Brexit, GSK mulls spin-off, Realta scores in CKD

The FDA has already indicated that in Alport syndrome patients, a significant improvement in placebo-corrected retained eGFR after one year of bardoxolone treatment may support accelerated approval and, after two ... years of bardoxolone treatment, may
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
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

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AstraZeneca: building a new ‘open innovation’ pharma company

Two of these five new launches received accelerated approval, confirming their innovative status, plus the firm also clocked up 14 other regulatory approvals across indication expan- sion and LCM projects in
Chinese biotech’s global ambitions

has just achieved a landmark approval in China for its own ‘home-grown’cancer medicine. ... BeiGene is preparing to submit in the first half of 2019 a New Drug Application (NDA) to pursue an accelerated approval of zanubrutinib for WM patients.
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

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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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Virgo Health is an award-winning global healthcare communications and medical education agency comprising specialists with some of the best skills,...

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