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

Teva’s migraine injection approved in Europe

The FDA also recently accepted an NDA from Botox developer Allergan, which filed its oral CGRP ubrogepant for the acute treatment of migraine in adults.

Celgene hopes for second time lucky for ozanimod FDA filing

application (NDA).

Novo uses voucher for speedy answer on oral semaglutide

A second NDA was also submitted for oral semaglutide, for which the Danish drugmaker are seeking approval for a cardiovascular risk reduction indication in adults with type 2 diabetes, but

Ipsen buys rare disease group Clementia in $1.3bn deal

A New Drug Application (NDA) for palovarotene for episodic flare-up treatment of FOP is expected to be submitted to the FDA in the second half of 2019, with a commercial ... In addition, should the FDA accept a future NDA filing for the drug in the

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