Europe
Novartis’ Entresto is well on its way to receiving approval as a treatment for heart failure patients following overwhelming support from a U.S. Food and Drug Administration (FDA) advisory committee.
It’s been a busy day so far for biopharma news and updates. Read on for more.
A little more than one year after Gilead Sciences and Galapagos NV announced intentions to seek regulatory approval for Jyseleca (filgotinib) as a treatment for rheumatoid arthritis, the companies have pulled the plug on that goal.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19.
The deal has been approved by both companies’ boards and is expected to close in the third quarter of 2021.
Another four companies join the Nasdaq, bringing the life science IPO count to over 70 this year.
In a shining moment that signaled hope for hemophilia B patients, uniQure presented data on Tuesday showing that its gene therapy treatment, etranacogene dezaparvovec (AMT-061), substantially increased production of the blood-clotting protein factor IX in nearly all pivotal Phase III HOPE-B trial participants.
The COVID-19 vaccine candidate developed by Sanofi and GlaxoSmithKline hit a snag that will delay the launch of a Phase III study due to an insufficient immune response in older trial patients.
It was an unusually busy week for clinical trial updates, largely because of the annual ASH meeting from Sunday December 5 through Wednesday December 9. There were also other meetings and the usual corporate updates.
PRESS RELEASES