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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.
AstraZeneca’s Imfinzi fails first-line bladder cancer test
The failed study sets back AZ’s plans to expand Imfinzi into the first-line bladder cancer category, although it has already been granted an accelerated approval in the US for ... Keytruda became the first checkpoint inhibitor to get a green light in
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IMV preps pivotal trials for ovarian cancer T cell therapy
IMV says it is now seeking a meeting with the FDA to try to work out the design of a larger phase 2b trial that could support accelerated approval of ... cyclophosphamide given on its own, which makes a path to regulatory approval unclear.
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Novartis plans inclisiran trial in the UK
In January, Novartis announced that it has teamed up with the NHS which will see patients in England receive accelerated access to inclisiran upon regulatory approval.
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Exelixis bounces back with new prostate cancer data
Exelixis intends to file the cabozantinib/Tecentriq combination with the FDA for accelerated approval in metastatic CRPC by 2021.
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EU grants conditional approval to Roche's lymphoma drug Polivy
The data have proven to be strong enough for Roche to win accelerated approval in the US and now a conditional authorisation in the EU. ... Winning conditional approval in the EU positions Roche to build on what it described as a ‘strong’ US launch.
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Wave’s challenge to Sarepta in Duchenne falls flat
Wave will abandon a phase 2/3 trial of suvodirsen called DYSTANCE 51, ending any hope of filing for accelerated approval of the drug as a potential rival to Sarepta’s ... It’s exon 53 skipping drug viltolarsen was filed for approval in October
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Latest Intelligence
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The Cystic Fibrosis Buyers’ Club
The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made
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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
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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.
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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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Infographic: China: How to keep up and win in the world's fastest changing healthcare market
Our latest infographic outlines the changes to the clinical trial process, accelerated drug approval, fast track of rare disease products and access opportunities in China's evolving healthcare environment.
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Parachuting Behind Enemy Lines: OncoSec’s Attack on Visceral Tumors via Its New Visceral Lesion Applicator (VLA)
Poster 717/Abstract 11375. 15. US Food and Drug Administration. Drugs. FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib. ... Accessed March 5, 2019. US Food and Drug Administration. Drugs. FDA grants accelerated
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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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COVID-19 Updates and Daily News
Featured jobs
- Regeneron launches phase 3 COVID-19 antibody trial in the UK
- Regeneron launches phase 3 COVID-19 antibody trial in the UK
- Roche’s Ocrevus boasts positive long-term data in MS
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- Leadership change within Bedrock Group
- Trials resume for AZ/Oxford University COVID-19 vaccine
- InSite Mapping™ - a Novel Tool for Insight-gathering and Patient Journey Mapping
- Envision Pharma Group scoops two Silvers at the PM Society Digital Awards 2020
- Alone we can do so little, together we can do so much
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- OPEN VIE is awarded a Bronze Award at the PM Society Digital Awards 2020
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Creative Medical Research
Specialising in medical device market research and participant recruitment human factors research, our approach is people-centric. We thrive on making...
Latest intelligence
- InSite Mapping™ - a Novel Tool for Insight-gathering and Patient Journey Mapping
- Learn how a client engaged 18 rheumatologist advisors over 6 months to create a patient journey map for SLE....
- Alone we can do so little, together we can do so much
- Collaboration is at the heart of successful patient engagement and effective healthcare provision. But in such a complex, nuanced network, true collaborations are rare. So how can we, as an...
- 7 important considerations for creating an inclusive clinical trial website
- You might have noticed that all of us here at COUCH Health are big advocates for taking action to improve diversity and inclusion in the world of clinical research. ‘Taking...
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