Please login to the form below

Not currently logged in
Email:
Password:

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.”.

Latest news

More from news
Approximately 0 fully matching, plus 135 partially matching documents found.

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

  • Drug safety

  • Drug R&D

More from intelligence
Approximately 0 fully matching, plus 21 partially matching documents found.

Latest appointments

  • 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 service offerings in the HTA

  • 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 US office ... Johan Stromquist, chief executive officer, NDA Group,

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

    UK-headquartered regulatory affairs consultancy the NDA Group has appointed Dr Paula Salmikangas as a director. ... Dr Werner Van den Eynde, VP of NDA’s Advisory Board, said: “I am very excited to welcome Dr Paula Salmikangas on board.

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

    Regulatory affairs consultancy group NDA has appointed Dr Werner Van den Eynde as its new vice president to head up its advisory board providing strategic advice to pharmaceutical clients during its ... His new role will see him manage strategy

  • NDA bolsters its senior team NDA bolsters its senior team

    Hires Eva Lilienberg, Christine Chirdo and Barbara Clendenen. Drug development consultancy NDA Group has expanding its service offerings and geographic reach with the addition of three new hires. ... Additionally, Christine Chirdo also joins the team as

More from appointments
Approximately 7 fully matching, plus 3 partially matching documents found.

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 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

More from PMHub
Approximately 0 fully matching, plus 2 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Cello Health Insight

Cello Health Insight is the global market research arm of Cello Health. With 35 years’ sector experience, we specialise in...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics