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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
Pfizer’s Prevnar-13 successor takes aim at Merck rival
The FDA also granted fast-track status for PF-06482077 last year. Pfizer says it is expecting to start phase 3 trials of the new vaccine in the coming months, and ... We look forward to continuing our dialogue with the FDA so that we can accelerate the
Latest news
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Boehringer’s Corsico to be new GSK drug dev leader
However the company has just received bad news from the FDA, the US regulator refusing to approval a licence extension for its respiratory drug Nucala into COPD, citing i nsufficient efficacy
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J&J files ‘breakthrough’ bladder cancer drug in US
Erdafitinib (JNJ-42756493) picked up a breakthrough designation (BTD) from the FDA earlier this year, so should benefit from a rapid review by the regulator, setting up a possible approval in
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Teva wins FDA OK for crucial migraine drug
Teva wins FDA OK for crucial migraine drug. Vital to Teva's turnaround, Ajovy will challenge Novartis/Amgen's Aimovig. ... Teva would have been earlier to market but the FDA review for its products was delayed by three months while it sorted out some
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AZ nabs US approval for new leukaemia drug Lumoxiti
AstraZeneca has chalked up another product approval in its oncology franchise, getting an FDA nod for Lumoxiti, a new CD-22-targeted drug for rare cancer hairy cell leukaemia (HCL).
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New data keeps AbbVie’s star pipeline therapies on track
Upadacitinib is already in a phase III trial in atopic dermatitis and picked up a breakthrough designation (BTD) from the FDA for this indication earlier this year.
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Latest Intelligence
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Cancer immunotherapy: What's on the horizon?
Between November 2016 and October 2017, the FDA approved 31 new therapies for more than 16 types of tumour, including the first cell-based therapies, the first tumour-agnostic drugs and ... also extending to targeted cancer drugs, with Loxo Oncology and
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Bluebird Bio: on the cusp of a gene therapy revolution
There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... However the FDA placed a clinical hold on the IND for the candidate in May,
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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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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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Mastering the precision medicine opportunity
Last year the FDA made a pioneering move in this space and approved Keytruda for use in adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or
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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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