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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
MaxCyte gets green light for solid tumour cell therapy
AIM-listed biotech MaxCyte has been cleared by the FDA to start trials of its chimeric antigen receptor (CAR) therapy for solid tumours, viewed as a tough challenge for this new
Latest news
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Daily Brief: success for Pfizer and Lilly arthritis drug, Darzalex soars, IMI launches Accelerator
The drug was the first in its class to receive FDA fast track status in June 2017.
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Daily Brief: success for Pfizer and Lilly arthritis drug, Darzalex soars, IMI launches Accelerator
The drug was the first in its class to receive FDA fast track status in June 2017.
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Roche’s Tamiflu successor hits the mark in complicated flu
Roche already has positive data from a phase III trials of baloxavir marboxil in uncomplicated flu, and recently filed for approval with the FDA for that indication, setting up a possible
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J&J’s Invokana aces diabetic kidney disease trial, setting up filings
the FDA extending its review for three months earlier this week.
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Roche keeps Venclexta train rolling with new leukaemia filing
AML is an aggressive disease with the lowest survival rate of all leukaemias, and we look forward to working closely with the FDA to bring this potential option to patients with
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Approximately 587 fully matching, plus 1,337 partially matching documents found.
Latest Intelligence
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30 women leaders in UK healthcare (part 3)
2004. Fifteen years on, the company’s lead product candidate, Lynovex, for the treatment of acute pulmonary exacerbations in Cystic Fibrosis, was recently granted FDA Fast Track Designation.
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A new era of smart pharma
The FDA recently approved a ‘digital pill’. The pill includes an embedded sensor that digitally tracks if patients have ingested it.
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Significant figures
US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status.
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Deal Watch January 2018
In October 2017 GSK's QS-21 Stimulon herpes zoster vaccine, Shingrix, was approved by the FDA.
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Drug safety
Healthcare terms - Drug safety.
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Approximately 2 fully matching, plus 95 partially matching documents found.
Latest appointments
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Celgene boosts CAR-T stake again with Bluebird Bio deal
Last year, the first two CAR-T products - from Novartis and Gilead Sciences/Kite - were approved by the FDA.
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Parexel expands global regulatory services team
US-based biopharmaceutical services company Parexel has bolstered its regulatory services team with the addition of three senior executives from the FDA and pharma. ... He has previously worked for the likes of Novartis, Igenix and the FDA.
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NDA Group appoints Alison McGregor as its principal consultant
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
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Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair
Dr Jenkins is also a committee member of the science board to the US Food and Drug Administration (FDA) and serves on the advisory board of its Center for Talent Innovation
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Teva's Mark Salyer joins Amarin
The 8, 000-patient study involves its first FDA-approved product, the omega-3 fatty acid-based Vascepa.
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Approximately 6 fully matching, plus 42 partially matching documents found.
Latest from PMHub
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Training the next generation of biotech leaders
In this year alone, the FDA has taken the groundbreaking step of approving two CAR-T therapies.
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21st Century Cures Act: a commercial perspective on how the new FDA regulation could revolutionise use of RWE and analytics in healthcare
Consistency with FDA labelling. To be very clear, this is not a yard sale on data! ... Factor 1: Does the information in the communication compare to information about those conditions in the FDA-required labelling?
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Raising Awareness: Rare Disease Day
References: 1.Rare Disease Day Website. Available at: . Last accessed: February 2017. 2.US FDA. Orphan products: hope for people with rare diseases.
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Pragmatic Digital Health
AstraZeneca is just one of many Pharma companies partnering with Adherium, an Australian company that makes a line of FDA cleared smart inhaler attachments.
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Could hackers threaten your health?
In this year’ s Def Con hacking conference, representatives from the US FDA, the government body responsible for the security of medical devices, spoke for the first time. ... There has also been an increase in regulatory action, with the FDA now
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Approximately 0 fully matching, plus 36 partially matching documents found.
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- Communiqué Awards 2018: Photo Gallery - Communiqué Awards 2016
- GSK sells eczema and psoriasis drug to Dermavant for £250m
- Moving annual total (MAT)
- Roche keeps Venclexta train rolling with new leukaemia filing
- NHS England says yes to Roche's Hemlibra
- Daily Brief: Trump arrives in London, NICE says no to Darzalex, Pfizer backs down on prices
- Daily Brief: success for Pfizer and Lilly arthritis drug, Darzalex soars, IMI launches Accelerator
- Brexit rebels win vote on European Medicines Agency alignment
- Data Visualisation
- The True Potential of Mobile Health Tech
- NHS England to Vertex: come clean on Orkambi offer
- Novartis follows Pfizer and freezes US prices this year
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StratX creates experiential learning programs instilled with emotion and competitive spirit, leading to lasting on-the-job change. Our memorable approach develops...
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