Eli Lilly granted fast track designation by FDA for obesity treatment

Lilly also outlined its plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be

Alpha Cognition announces positive results for Alzheimer’s disease treatment

The results, along with positive pivotal data released in June evaluating galantamine hydrobromide’s immediate release (IR), 'strengthen the New Drug Application (NDA) for ALPHA-1062 in mild-to-moderate AD, ... lead asset, ALPHA-1062, which further

Pfizer told by FDA to test additional Paxlovid course in patients with COVID-19 rebound

In June, Pfizer announced the submission of a New Drug Application (NDA) to the FDA for the approval of Paxlovid for both vaccinated and unvaccinated patients who are at high risk ... The NDA submission follows positive results from a phase 2/3 EPIC-HR

GSK’s application for momelotinib in myelofibrosis with anaemia accepted by FDA

GSK’s New Drug Application (NDA) for momelotinib has been accepted by the US Food and Drug Administration (FDA) for patients who have myelofibrosis with anaemia. ... We are thrilled to submit this NDA on behalf of myelofibrosis patients and look

Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

Arcutis Biotherapeutics (Arcutis) has announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the company’s 0.3% cream, Zoryve (roflumilast), 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

5 Reasons To Add Character Animation To Your Next Campaign.

Working primarily in Healthcare, the vast majority of our work is covered by NDAs, so you may never know what else we offer.

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