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Partnership with payers: Communicating and negotiating with impact

NDA's Lisa Peluso, Director, Coaching and Client Engagement, outlines key strategies for interacting with audiences and payers while maximising team alignment when it comes to delivering a product to market.

Interactions with the Agencies During Drug Development

Published date: 
30/04/2019
Summary: 
NDA would like to invite you to join Professor Steffen Thirstrup, Director NDA Advisory Board, formerly Division Head at the Danish Medicines Agency and CHMP member and Dr Rosalind Cox, Principal consultant NDA UK, formerly Divisional VP with Abbot, share their experiences and provide their insights into making the most of the opportunities to interact with EU Agencies during the drug development process.

 

NDA would like to invite you to join  Professor Steffen Thirstrup, Director NDA Advisory Board, formerly Division Head at the Danish Medicines Agency and CHMP member and Dr Rosalind Cox, Principal consultant NDA UK, formerly Divisional VP with Abbot, share their experiences and provide their insights into making the most of the opportunities to interact with EU Agencies during the drug development process.

Europe vs USA: New drug approvals

Published date: 
01/06/2017
Summary: 
Dr Terese Johansson, Regulatory Affairs Consultant NDA Group AB, examines the drop in US approvals while observing no similar trend occurred in the EU during 2016

Dr Terese Johansson, Regulatory Affairs Consultant NDA Group AB, examines the drop in US approvals while observing no similar trend occurred in the EU during 2016.

FDA new drug approvals sink to six year low

The FDA has released figures to show that drug approvals have fallen from last year’s high of 45 new drugs approved to this year’s figure of 19. The recently passed 21st Century Cures Act should see new drug approvals speed up but it’s a worry for the FDA when President-elect Trump has already made pointed comments about increasing access to drugs at a faster rate.

Celgene and Agios to file FDA application for “first-in-class” cancer drug

According to an SEC 8-K filing by Agios, the company and its partner Celgene intend to file a new drug application (NDA) for a “first-in-class” cancer drug, intended to treat relapsed or refractory acute myeloid leukaemia. The NDA is expected to be filed before the end of the year.

FDA delays appraisal of Sanofi, Zealand diabetes drug just days before decision due

There was unfortunate news for Sanofi and Zealand Pharma as the FDA announced that it required additional information, constituting a major amendment to the new drug application, for iGlarLixi.

iGlarLixi is a fixed-ratio combination of Adlyxin TM (lixisenatide) and Lantus (insulin glargine injection) and the FDA have asked for updated information on the pen delivery device for the drug combination.

GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results

GW Pharmaceuticals (Nasdaq: GWPH) said late-stage trials for its Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy achieved its primary endpoint. 

Epidiolex in combination with the current treatment showed a significant reduction in the monthly frequency of drop seizures assessed over the entire 14-week treatment period, the company said in a statement. The trial follows the positive results from a Phase III study in March for Epidiolex to treat Dravet syndrome. 

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding its new drug application (NDA) for the drug candidate to treat hyperkalaemia.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The drug is being developed by ZS Pharma, a unit of AstraZeneca.

Lilly awaits FDA review of new arthritis treatment

Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid arthritis (RA).

The drug, an oral once-daily JAK1 and JAK2 inhibitor, was licensed from Delaware-based Incyte Corporation in 2009, with an agreement that Incyte would receive milestone payments based on certain conditions being met. One such payment related to NDA submission, meaning Incyte receive will $35 million from Lilly immediately.

Novo Nordisk files for new insulin approval

Novolog pen
The new drug application is for a faster-acting formulation of NovoLog

Novo Nordisk has submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA.

If successful, the Danish firm says it plans to Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch. It would offer the company another selling point to add to its portfolio of diabetes medicines.

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