EMA’s human medicines committee (CHMP) has completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospitals, and has concluded that...
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Top Law Firm’s Italian Clinical Trial Specialists Discuss Challenges & New Opportunities Conducting Clinical Trials in Italy During COVID-19
The EU Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new guidelines on April 28, 2020 on the management of clinical trials during the COVID-19 pandemic. Serving as a set of harmonized recommendations across the EU,...
European Medicines Agency Seeks ‘Harmonized Approach’ to Clinical Trials Addressing COVID-19 in the EU
Has European research into a COVID-19 treatment been too fragmented? Apparently, the European Medicines Committee (CHMP or EMA) thinks so based on a recent statement meant for investigation there. The overarching regulatory authority now promotes a “harmonized...
Drug Study Report Transparency vs. Industry Interests: A Battle Building in Europe
Europe’s biopharma sponsors, or at least some of them, are resisting transparency when it comes to the proactive publishing of study reports upon completion of the study. The European Medicines Agency (EMA) gradually improved its transparency policy. With Brexit and...
European Commission Publishes GCP Guidelines Specific to Advanced Therapy Medicinal Products (ATMPs)
The European Commission recently published the Guidelines for Good Clinical Practice (GCP) specific to advanced therapy medicinal products (ATMPS) covering gene therapies, cell therapies and tissues engineered products. Context Regulation (EC) No 1394/2007 (ATMP...
Baby Pia Denied Compassionate Use: Something ‘Ain’t’ Right in Basel
Novartis just can’t keep out of bad news. They have denied a request from the Belgian federal government to make the most expensive drug in the world (Zolgensma at $2 million) available to a Belgian toddler named Pia who suffers from spinal muscular atrophy, despite...
U.S. and Europe Reach Mutual Recognition of Inspection Milestone
The European Union and the United States have fully implemented the Mutual Recognition Agreement, or MRA, for inspections of manufacturing of (bio) pharmaceutical sites for certain human medicines in respective territories. Apparently, the deal was inked after the...
Denmark Medicines Agency Scrutinizing Industry Relations in Effort to Rein in on Conflict of Interest
The Denmark Medicines Agency has initiated new rules requiring employees to dispose of any company shares prior to the hiring date. The new rules prohibit the recruitment of executives with pharmaceutical or medical device company equities. The Danish response is...
European Medicines Agency Rejects Amgen and UCB’s Osteoporosis Medication Romosozumab
Amgen and UCB’s osteoporosis drug romosozumab was rejected by the European Medicines Agency (EMA) due to the potential for cardiovascular risks. EMA declared that they found some evidence that the drug known as Evenity increases the probability of myocardial...
European Medicines Agency Guideline on Content, Management & Archiving of Clinical Trial Master File
The European Medicines Agency (EMA) published its Guideline on Content, Management and Archiving of Clinical Trial Master File (paper and/or electronic) to address the usage of both paper and electronic document management for sponsors, clinical investigator and other...
European Medicines Agency 2018 Annual Report: Summary of Drug Approvals & Denials
Based in Amsterdam, the European Medicines Agency (EMA) produced their annual 2018 report making it available to the public today (see source link below). EMA is a European Union (EU) agency for the evaluation and supervision of medicinal products. EMA was set up in...