News

Enlarge image

RegulatoryEUUK

EMA rules for cancer drugs

15.01.2013 - The European Medicines Agency has updated guidelines on cancer drugs in clinical development.

„Convincingly demonstrated favourable effects on overall survival (OS) are from both a clinical and methodological perspective, the most persuasive outcome of a clinical trial“, the London-based Agency writes in its new guidelines that will come into force this July. However, prolonged progression-free or disease-free survival will be, in most cases, be considered relevant measures of patients benefit, but the magnitude of the treatment effect has to be sufficiently large to outbalance toxicity and tolerability problems.

Alongside conventional aims such as defining the proper doses and schedule for a medicine, the guideline highlights the importance of identifying the target population during the development. With regard to the co-development of stratification biomarkers, personalised medicine has become reality. The new guidance document covers the use of biomarkers as an integrated part of drug development. This means that in most cases, hypotheses are to be tested and confirmed with appropriate candidate biomarkers through all phases of clinical development. In cancer indication the Agency sees a substantial need for biomarker tests whereas in other indications they might be more „informative“.

Confirmation trials should demonstrate that the investigational product provides clinical benefit. From both a clinical and a methodological perspective, the most persuasive outcome of a clinical trial is the demonstration of favourable effects on overall survival. Prolonged progression-free survival and disease-free survival are also considered to be of benefit to the patient. The guideline describes how to select the appropriate endpoints for confirmation studies.

Two appendixes complement the guideline, to address methodological considerations for using progression-free survival in confirmatory trials, and to provide condition specific guidance for non-small cell lung cancer (NSCLC), prostate cancer, chronic myeloid leukaemia (CML), myelodysplastic syndromes, and haematopoietic stem cell transplantation.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/ema-rules-for-cancer-drugs.html

R&DUKIreland

29.07.2016 GlaxoSmithKline has in-licensed Janssen’s anti-IL-33R monoclonal antibody for severe asthma. The British drugmaker is paying €208m up front for the mAb.

ResearchEUUK

27.07.2016 In view of the Brexit, research academies across Britain are calling for a “bold commitment” from the government. The Royal Society President urges the UK government to underwrite the research of British scientists applying for EU funding.

FinancingBelgium

20.07.2016 Belgian molecular diagnostics company Biocartis Group NV has raised €55m and will use the funds mainly to expand manufacturing capacities for its PCR-based molecular diagnostics system Idylla.

Stock marketsFranceEU

19.07.2016 It is Europe’s first gene therapy company to float on Euronext: Gensight raised €40m in its IPO. And it is not the only French company that has taken the leap in an uncertain market climate – Alzheimer’s expert Pharnext also went public.

ResearchUK

18.07.2016 When NASA blasted off to the International Space Station on Monday morning, it had UK tech on board. A miniature DNA sequencer from Oxford Nanopore will be used to keep an eye on the ISS atmosphere – and may even analyse alien DNA one day.

M&AUKSwitzerland

13.07.2016 Cell Medica has acquired Swiss antibody specialist Delenex Therapeutics. The deal nets the British cellular therapeutics developer Delenex’ proprietory antibody fragment platform Pentrabody.

R&DAustriaFrance

12.07.2016 Vienna-based vaccine specialist Themis Bioscience GmbH has secured broad access to a promising virus vaccine vector tech by extending its license agreement with French Institut Pasteur. Its goal: to develop a Zika vaccine.

M&AFranceEU

07.07.2016 Californian biopharma Medivation has agreed to confidential negotiations with its suitors, in particular the French pharmaceutical company Sanofi, which aggressively has buffeted the cancer therapy specialist for months.

Prenatal DiagnosticsEUUK

06.07.2016 The European Commission started an investigation into Illumina’s and Sequenom’s 2014 patent agreement, UK-competitor Premaitha Health said. The two US companies had agreed to pool their Noninvasive Prenatal Testing IP.

GenericsSpainGermanyEU

04.07.2016 Cinfa Biotech is shuffling for position on the lucrative biosimilar market. The Spanish-German company has published positive results in a study for a pegfilgrastim copycat with 172 healthy volunteers in Germany.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • DIAMYD MEDICAL -B- (S)5.70 SEK21.54%
  • QIAGEN NV (D)23.48 EUR12.29%
  • MOBERG PHARMA (S)44.10 SEK10.25%

FLOP

  • MOLOGEN (D)1.81 EUR-11.71%
  • NICOX (F)9.62 EUR-8.29%
  • SAREUM HOLDINGS (UK)0.72 GBP-6.49%

TOP

  • PROTHENA PLC (IE)55.05 USD57.5%
  • DIAMYD MEDICAL -B- (S)5.70 SEK37.3%
  • VERNALIS (UK)44.50 GBP31.9%

FLOP

  • MOLOGEN (D)1.81 EUR-38.4%
  • SANTHERA (CH)56.20 CHF-26.9%
  • EVOCUTIS (UK)0.04 GBP-20.0%

TOP

  • KARO BIO (S)33.00 SEK1962.5%
  • NICOX (F)9.62 EUR425.7%
  • SAREUM HOLDINGS (UK)0.72 GBP213.0%

FLOP

  • BB BIOTECH (D)44.83 EUR-84.6%
  • NEUROVIVE PHARMACEUTICAL AB (S)4.80 SEK-78.2%
  • EVOCUTIS (UK)0.04 GBP-76.5%

No liability assumed, Date: 29.07.2016