A Painstaking Approach: Can Anti-NGFs Give Relief To Pharma Pipeline Woes?
Analgesic drugs have reached a painful point. Unwanted side effects and abuse potential have made existing drug categories such as non-steroidal anti-inflammatories and opioids unappealing prescriptions for patients in chronic pain. But a new class of antibodies that inhibit the crucial protein nerve growth factor could spell relief for millions of chronic pain sufferers - if they can demonstrate safety and efficacy
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.