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...
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...
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...
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...
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...
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...
