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NDA

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

Alnylam seeks fast-track filing with biomarker data

Alnylam seeks fast-track filing with biomarker data

FDA. to discuss the results and the overall benefit-risk profile for a potential NDA submission at or around year-end in support of an accelerated approval.”.

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Latest Intelligence

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

    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.

  • Significant figures Significant figures

    a company right now is our NDA filing of ALIS in the US.”. ... Olaf said that ALIS’second NDA filing will most likely be in Japan due to its big NTM population and the regular frequency of physicians testing for NTM disease in patients.

  • Licensing

    Healthcare terms - Licensing.

  • Drug safety

    Healthcare terms - Drug safety.

  • Drug R&D

    Healthcare terms - Drug R&D.

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Latest appointments

  • Claes Buxfeldt joins NDA Claes Buxfeldt joins NDA

    Claes Buxfeldt joins NDA. He becomes its new HTA director. AstraZeneca’s former global price and reimbursement director Claes Buxfeldt has joined the NDA advisory board. ... Buxfeldt’s new role at NDA will see him drive and develop the group’s

  • NDA Group appoints Alison McGregor as its principal consultant NDA Group appoints Alison McGregor as its principal consultant

    NDA Group appoints Alison McGregor as its principal consultant. She joins the group following a new US office launch. ... Drug development consultancy, NDA Group, has appointed Alison McGregor as its principal consultant following the opening of its new

  • Dr Paula Salmikangas joins NDA Group Dr Paula Salmikangas joins NDA Group

    Dr Paula Salmikangas joins NDA Group. Moves to the regulatory affairs consultancy from the Finnish Medicines Agency. ... UK-headquartered regulatory affairs consultancy the NDA Group has appointed Dr Paula Salmikangas as a director.

  • NDA Group appoints new vice president NDA Group appoints new vice president

    NDA Group appoints new vice president. Dr Werner Van den Eynde will also lead its advisory board. ... His new role will see him manage strategy operations and development of the NDA advisory board, including business development, sales, marketing and

  • NDA bolsters its senior team NDA bolsters its senior team

    NDA bolsters its senior team. Hires Eva Lilienberg, Christine Chirdo and Barbara Clendenen. ... Additionally, Christine Chirdo also joins the team as NDA’s new service area lead for high stakes meetings.

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Latest from PMHub

  • Weinberg Group

    The Weinberg Group is the global leader in regulatory and compliance services. We have provided biotech, medical device and pharmaceutical consulting services for over 30 years.

  • NDA

    NDA. NDA is Europe’ s leading regulatory affairs consultancy, providing clients with a unique insight into EU regulatory thinking and the best possible expert guidance and support to optimise the time ... Year on year, NDA has contributed towards more

  • Research and development

    NDA is Europe’ s leading regulatory affairs consultancy, providing clients with a unique insight into EU regulatory thinking and the best possible expert guidance and support to optimise the time to ... Year on year, NDA has contributed towards more

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