Bayer’s finerenone scores FDA priority review for chronic kidney disease

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.

Amgen aims for first KRAS inhibitor approval in the US

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

Merck, Bayer get FDA priority review for heart failure drug

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

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

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

The Good Ideas Group

NHS, COMPASS Pathways, Unilabs, Allergan and many more under NDA.

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