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EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

www.ema.europa.eu

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List of articles in category EMA
Title Published Date
EMA's medical literature monitoring enters into full operation 09 September 2015
EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications 21 August 2013
European Medicines Agency website on suspected side effect reports now in all 23 EU official languages 19 June 2012
European Medicines Agency boosts EU transparency 31 May 2012
European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections 11 December 2011
European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs 24 October 2011
European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix 22 February 2011
European Medicines Agency completes its review of Avastin used in breast cancer 16 December 2010
European Medicines Agency and ENCePP launch electronic Register of Studies 25 November 2010
European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements 20 September 2010
European Medicines Agency holds international workshop on clinical trials 15 September 2010
European Medicines Agency starts review of Pandemrix 31 August 2010
EMA and US FDA seek potential candidate companies for joint GMP inspection programme 12 August 2010
European Medicines Agency starts review of rosiglitazone-containing medicines 15 July 2010
European Medicines Agency implements internal reorganisation 12 October 2009
The bacterial challenge - time to react 18 September 2009
European Medicines Agency review of pandemic vaccines underway 25 July 2009
European public health agencies evaluate antibiotic resistance of Staphylococcus aureus 17 June 2009
European Medicines Agency recommendations on extension of shelf life for Tamiflu 09 May 2009
EMEA-coordinated PROTECT project has been accepted for funding 01 May 2009
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Business & Industry

  • GSK completes acquisition of Sierra Oncology
  • Pfizer and BioNTech announce new agreement with U.S. government to provide additional doses of COVID-19 vaccine
  • Bayer opens new Research & Innovation Center in Boston-Cambridge demonstrating its commitment to precision oncology
  • New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3)
  • Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against Omicron

Research & Development

  • Inhalable COVID-19 vaccine shows promise in rodent model
  • Researchers discover new leukemia-killing compounds
  • Oral antiviral drug effective against respiratory syncytial virus (RSV) identified by researchers
  • Biomarkers found that could be drug targets against a deadly form of brain cancer
  • COVID-19 rebound after taking Paxlovid likely due to insufficient drug exposure
  • Novel drug combo activates natural killer cell immunity to destroy cancer cells
  • Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants

Conferences & Events

  • New approach to treatment of deadly kidney cancer
  • SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference

Regulatory Affairs

  • FDA approves first systemic treatment for alopecia areata
  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
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