spacer
home > > autumn 2009 > thoughtful testing
PUBLICATIONS


Thoughtful Testing

 

The European Medicines Agency (EMEA) is a decentralised body of the EU. Its main responsibility is the safety and promotion of public health, through the evaluation and supervision of medicines for human use. The EMEA holds responsibility for the scientific evaluation of applications for European marketing authorisation of medicinal products (1).

NEW GUIDELINES

On 1st February 2009, the EMEA released new guidelines for companies developing medicines for the treatment of Alzheimer’s disease (AD) and other dementias, and for Parkinson’s disease, in the light of recent scientific progression in the understanding of these diseases and conditions (2). The document itself is offered as general guidance on the development of medicinal products for the treatment of dementia and its subtypes. It does not replace other EMEA and ICH guidelines, but rather works in collaboration with them.

The advances over the past few years in both clinical science and molecular biology have contributed to an emphasis on and growing interest in the development of more valuable symptomatic or disease-modifying treatments, such as early treatments that could prevent the emergence or even slow the progression of a disease. These guidelines have been developed to assist companies developing such medicines on appropriate clinical trial designs (2).


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Helen Brooker began working for CDR Ltd in March 2008 and is an active member of the R&D team. She graduated with a first class honours degree in 2006 and went on to be involved in numerous research projects. She is currently embarking on her MSc in Psychology. Helen is the R&D project manger and manages the CDR Collaborative Research programme, where she works with key medical institutions and universities across the globe. She works closely with the expanding scientific development team as well as providing scientific support to business development.

spacer
Helen Brooker
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

BEERSE, BELGIUM, May 18, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv]
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement