BioSpace News Archive

Palbociclib is the standard of care for patients with advanced breast cancer, yet researchers still have no molecular profile to predict which patients will progress, which will continue benefitting from this therapy after their initial treatment, and which combination therapies are most effective.

Another four companies join the Nasdaq, bringing the life science IPO count to over 70 this year.

If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.

Sanofi announced yesterday that they will resume dosing in U.S. clinical trials. They noted that on October 30, they had “voluntarily paused dosing in all ongoing fitusiran clinical studies … to assess reports of non-fatal thrombotic events in patients participating in the Phase III program.”

AstraZeneca, which is jointly developing a COVID-19 vaccine with the University of Oxford, plans to begin clinical trials testing its vaccine in combination with Russia’s Sputnik V vaccine by the end of the year.

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.

As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.

A COVID-19 vaccine being developed by CSL Ltd., and the University of Queensland was scrapped this week after numerous vaccine recipients reported receiving false positives on certain HIV tests.

A Biogen corporate conference held in February at the Boston Marriott Long Wharf Hotel was initially traced to about 100 cases of COVID-19 that spread across the country. That number has grown exponentially.

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.