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.
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The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
The EMA has said that patients should continue to use angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), despite reports that these worsen COVID-19 infections.
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
The SISCO study will assess if the anti-IL-6 antibody siltuximab can aid patients suffering Acute Respiratory Distress Syndrome as a complication of the COVID-19 coronavirus.
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
The European Medicines Agency (EMA) announced it will provide free advice to those working on COVID-19 therapeutics and vaccines in the hopes of accelerating approval of a treatment.
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
An EU Executive Steering Group will discuss how to address the impact of medicine shortages caused due to COVID-19, says the EMA.
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.