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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
Rigel and Ultragenyx claim approvals for rare drugs
The FDA gave the go-ahead to a pair of rare disease therapies this week, both marking the first-ever approvals for developers Rigel Pharmaceuticals and Ultragenyx. ... Rigel got a green light from the FDA for chronic immune thrombocytopenia (ITP) therapy
Latest news
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BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer
The combination of Opdivo and Yervoy lies at the heart of much of Bristol-Myers Squibb’s ambition in immuno-oncology, and an FDA approval for the pairing in kidney cancer ... BMS notes that Opdivo and Yervoy was given a priority review by the FDA last
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Alkermes slumps as FDA turns down depression drug
Alkermes was hoping that the massive unmet need in patients with MDD would help sway the FDA. ... Alkermes strongly disagrees with the FDA's conclusions and plans to appeal the FDA's decision, ”said the company in a statement.
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Seattle Genetics claims key US approval for Adcetris
According to the FDA, there were around 8, 260 people diagnosed with Hodgkin’s lymphoma last year. ... Last November it was granted FDA approval in adult patients with cutaneous T cell lymphoma (CTCL) and there is more to come.
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FDA approves another home genetic testing service
FDA approves another home genetic testing service. 23andMe’s kit will check for an increased risk of certain cancers developing. ... The US Food and Drug Administration (FDA) has authorised another one of 23andMe’s home genetic kits, and this one
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AbbVie’s uterine fibroids drug aces second phase III trial
AbbVie’ s uterine fibroids drug aces second phase III trial. An FDA verdict is expected in the US in the coming weeks. ... The two companies are currently waiting for an FDA verdict in the US in the coming weeks on elagolix as a treatment for
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Latest Intelligence
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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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The good, the bad and the ugly
The Israeli multinational has blamed the decline on the increase in generic drug approvals by the FDA, saying that increased competition and ‘customer consolidation’had hurt sales.
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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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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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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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Immunotherapy in oncology
To date, Blue Latitude Health have worked with 4 of the 9 immunotherapies currently approved by the FDA, and this article will provide an overview of the area; sharing some of ... approval by the FDA in March 2011.
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Are you ready for the MSL role?
Are you ready for the MSL role? Be prepared: FDA looks beyond employee training records during inspections as one FDA investigator states.
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Alzheimer’s disease: reviewing the immediate treatment horizon
In it, he highlighted how, despite continued investment by pharmaceutical companies into AD treatment research, AD sufferers still only have 5 FDA-approved treatments to choose from, and even these are
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