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EMA warns about side effects of chloroquine and hydroxychloroquine for COVID-19 treatment europeanpharmaceuticalreview
April 24, 2020
The COVID-19 European Medicines Agency (EMA) pandemic Task Force (COVID-ETF) warned that chloroquine and hydroxychloroquine are yet to be proved effective at treating COVID-19 and that their side effects could be fatal.
FDA and EMA agree to review shorter infusion time of Roche’s Ocrevus pharmaceutical-technology
April 22, 2020
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to review Roche’s applications for a shorter infusion time of Ocrevus to treat relapsing or primary progressive multiple sclerosis (MS).
EMA confirms skin cancer risk with LEO's Picato pharmatimes
April 20, 2020
The European Medicines Agency's safety committee (PRAC) has confirmed that LEO's Laboratories' Picato (ingenol mebutate), used to treat the skin condition actinic keratosis, may increase the risk of skin cancer.
EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines europeanpharmaceuticalreview
April 15, 2020
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
WuXi Biologics (Suzhou) Successfully Passed First EMA GMP Inspection Wuxi Biologics
April 14, 2020
WuXi Biologics, a global company with leading open-access biologics technology platform, announced that WuXi Biologics (Suzhou) Co., Ltd. has successfully passed its first GMP inspection by the European Medicines Agency (EMA).
EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic europeanpharmaceuticalreview
April 09, 2020
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
EMA recommendations on compassionate use of remdesivir for COVID-19 europeanpharmaceuticalreview
April 07, 2020
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
EMA releases its regulatory strategy for next five years europeanpharmaceuticalreview
April 06, 2020
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
EMA accepts marketing authorisation application for anti-epileptic drug cenobamate europeanpharmaceuticalreview
April 03, 2020
Cenobamate’s application was based on a global clinical trials programme enrolling over 1,900 adults with uncontrolled focal-onset seizures.
EMA advises malaria drugs use for trials only; FDA records shortage pharmaceutical-technology
April 03, 2020
The European Medicines Agency (EMA) has urged that two malaria drugs, chloroquine and hydroxychloroquine, being tested as potential Covid-19 treatment, must only be used for clinical trials or national emergency use programmes.

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