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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.
Abivax’s COVID-19 study declared Research National Priority by French government
Those clinical trials, including Abivax’s study, that are declared to be a national priority gain access to an accelerated regulatory review and approval process by the French regulatory authorities (ASNM) ... Results from the ongoing study are
Latest news
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Gilead set to acquire hepatitis specialist MYR for €1.15bn
It is currently the first and only drug with conditional approval in the EU for HDV. ... In addition to the EMA conditional approval, MYR expects to submit Hepcludex to the US Food and Drug Administration (FDA) for accelerated approval in the second half
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Jazz Pharma’s SCLC drug fails to meet primary endpoint in combo trial
It won that approval based on prior phase 2 data, announced by PharmaMar at the 2019 American Society of Clinical Oncology congress, which had shown an overall response rate of ... accelerated and/or full regulatory approval of lurbinectedin by the FDA
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Be careful what you wish for
So wishing for an accelerated approval, given the trade-off required on safety and efficacy, is simply a bad idea. ... But another reason you don’t want to wish for an accelerated vaccine is a much more subtle and nuanced justification.
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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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Latest Intelligence
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How will COVID-19 affect uptake of vaccinations against other diseases?
A particular threat in this regard could come from the accelerated clinical development programmes and expedited approval processes that are being put in place to push through SARS-CoV-2 vaccines.
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Surviving cancer: a new era for patients
The FDA recently granted accelerated approval for the ADC trastuzumab-deruxtecan in patients with breast cancer, with progression-free survival (PFS) rates showing that longer life is a real possibility – a
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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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Latest from PMHub
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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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- Sinovac’s COVID-19 vaccine appears safe in older adults
- Celltrion’s investigational mAb cuts COVID-19 recovery time
- New study identifies drugs that are safe to use in COVID-19 treatment
- UK pharmacies to begin administering COVID-19 vaccinations
- PHE study finds people who have had COVID-19 can still transmit the virus
- CureVac set to begin phase 3 COVID-19 vaccine study in healthcare workers
- EU proposes vaccine-sharing mechanism with low-income countries
- Valneva set to begin commercial manufacturing of COVID-19 vaccine within days
- WHO’s director-general deems vaccine nationalism a “catastrophic moral failure”
- Lilly partners with Merus on development of bispecific antibodies for cancer
- Medical research charities need our help – support is needed to continue funding life-saving research and improving lives
- Research Partnership appoints Hannah Osborn to MedTech director role
Latest intelligence
- Sourcing R&D innovation: why pharma companies need to evolve their business models
- Recent years have seen a significant shift in drug development to specialty areas...
- 2020 - a year to remember or forget?
- 2020 and the Covid pandemic brought immense challenges, and the need for change felt like it happened overnight. What have we learned and what does the future of agency working...
- The search for effective drug treatments for COVID-19
- PME talks to Julian Cole, Senior Director, Medical Affairs at Gilead Sciences...
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