This page shows the latest NDA news and features for those working in and with pharma, biotech and healthcare.
BMS’ new drug application (NDA) for mavacamten in this indication is based on results from the phase 3 EXPLORER-HCM trial in patients with symptomatic oHCM versus placebo.
Earlier this year, Farxiga also won a priority review from the FDA, with a decision on the new drug application (NDA) expected in the second quarter of 2021. ... NDA within six months of acceptance, setting up a potential decision in July.
The company has filed a new drug application (NDA) with the FDA for the investigational KRAS inhibitor, seeking approval for the treatment of patients with KRAS G12C-mutated locally advanced or ... The NDA for sotorasib is being reviewed under the
The New Drug Application (NDA) filed for vericiguat is aiming for approval as a treatment to reduce the risk of cardiovascular death and heart failure hospitalisation following a worsening heart failure
The NDA approval was awarded to Acthar’s earlier owner Questcor, which was acquired by Mallinckrodt for $5.6bn in 2014.
For Intellipharmaceutics, the status of Aximris is now quite bleak – in a statement, the company said “there can be no assurance that the FDA will ultimately approve the NDA for the
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China indicated it would no longer tolerate inauthentic or incomplete clinical data when it asked companies with pending new drug applications (NDAs) to self-assess their submissions. ... When faced with the threat of punishment if they proceeded with
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.
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.
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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
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,
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.
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
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
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NHS, COMPASS Pathways, Unilabs, Allergan and many more under NDA.
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 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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We are a patient engagement agency committed to making clinical study experiences human. By guiding organisations in making everything they...