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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.

Better together when buying medicines? Taking stock of the BeNeLuxA initiative

The price negotiations started in February 2018, eight months after marketing authorisation came from the EMA for Spinraza, following EMA’s accelerated approval process. ... Biogen said it worked with BeNeLuxA for 18 months to secure the deal, engaging

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BioMarin eyes 2019 FDA filing for haemophilia A gene therapy

The California biotech said during an R&D update yesterday that new FDA guidance on gene therapy for haemophilia suggests that study may support accelerated approval for the one-shot therapy, ... our development and accelerated regulatory strategy,”
Pfizer claims rapid FDA nod for Lorbrena

The US regulatory body awarded the drug with an accelerated approval, acknowledging successful overall response rates of 48%. ... However the approval is a conditional one, meaning that the FDA will continue to monitor results from further trials.
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
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

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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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Aptus Health

Aptus Health is dedicated to advancing health engagement. The company offers end-to-end digital health engagement solutions spanning all areas of...

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Combined immunotherapies – potential and pitfalls: ‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today: Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham: Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...