GSK Bio
NEWS
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma.
Promising data from the DREAMM-7 and DREAMM-8 trials have revitalized GSK’s blockbuster goals for its antibody-drug conjugate Blenrep, positioned as a second-line treatment for multiple myeloma.
Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
On Monday, GSK reported that a plaintiff voluntarily dropped her Zantac case against the company and that it is in the process of appealing a Delaware State Court’s decision to admit expert testimony in other cases.
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
Analysts predict a booming year for mergers and acquisitions, powered by obesity drug sales and pressure from upcoming patent expirations.
A Delaware state court ruled that expert witnesses can present scientific evidence in 69,000 cases involving the discontinued heartburn drug Zantac. News of the court ruling Monday wiped roughly $8.9 billion from GSK’s market value.
Stay tuned to BioSpace as we keep you updated on all of the biggest data and news from the conference.
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.
JOBS
IN THE PRESS