Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
Mylan and Upjohn (a Pfizer company) revealed they have delayed the transaction due to meeting restrictions and concerns over staff health and safety during the COVID-19 pandemic.
The survey indicates that almost all respondents were concerned about the COVID-19 pandemic’s effects on company performance, including supply and demand failures.
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.
Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
In the UK, the CMA has announced it will establish a taskforce to handle businesses that exploit the COVID-19 outbreak and inflate drug prices.
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 EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
Professor Gillian Leng has been appointed as the new Chief Executive of NICE and will take over from Sir Andrew Dillon in early April.
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
The US District Court of Columbia has upheld the decision to alter rebate calculations and left Mallinckrodt with a retroactive liability of $650 million.
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.