US piles pressure on Mallinckrodt over alleged Acthar fraud

The NDA approval was awarded to Acthar’s earlier owner Questcor, which was acquired by Mallinckrodt for $5.6bn in 2014.

FDA committee rejects Intellipharmaceutics’ opioid drug Aximris

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

FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

In the span of four months, we commenced and completed the formal dispute resolution process culminating in the grant of our appeal, resubmitted our NDA and obtained an approval – a great

Vertex files cystic fibrosis triple therapy with FDA

The submission of the NDA is a major step toward our goal of bringing this medicine to the largest remaining group of people with CF that still do not have an ... We will continue working with the FDA as they review the NDA and look forward to the

J&J’s targeted bladder cancer treatment gets US approval

Incyte are also reviewing their candidate in advanced/metastatic or surgically unresectable bile duct cancer with fibroblast growth factor (FGF)/FGFR genetic alterations and expects to file an NDA later this

China’s clinical trial shake-up

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

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

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

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

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

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

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

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

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