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FDA

This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.

Novartis buys cancer specialist Endocyte for $2.1bn

Lutathera brought in $56m as it continues to roll out in the US following FDA approval in January, which Novartis said was a good performance, but while CAR-T Kymriah saw

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  • Retaining reader value in plain language summaries of clinical studies Retaining reader value in plain language summaries of clinical studies

    The US FDA has also issued a draft document for consideration in relation to equivalent measures, so it is possible that measures ironed out now will serve firms more broadly in

  • Chinese biotech’s global ambitions Chinese biotech’s global ambitions

    Its BTK inhibitor zanubrutinib was granted Fast Track designation by the US FDA in July for the treatment of patients with Waldenström macroglobulinaemia (WM), based on phase 1 data.

  • Cancer immunotherapy: What's on the horizon? 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

  • Bluebird Bio: on the cusp of a gene therapy revolution 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,

  • 30 women leaders in UK healthcare (part 3) 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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patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

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