Europe’s Biotechs Want Flexibility When Seeking Scientific Advice
This article was originally published in The Pink Sheet Daily
Biotechs and smaller companies have called for more flexibility and informal dialogue when seeking scientific advice from Europe’s regulators and HTA bodies on the development of their investigational medicines, says a joint survey by EuropaBio and the Deerfield Institute.
You may also be interested in...
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
AZ's Rare Disease Unit Reports Positive Phase III Results For Copper-Binding ALXN1840
Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.