BioSpace News Archive

Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.

After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.

Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.

The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.

At the World Vaccine Congress, antimicrobial resistance as a global health crisis grabbed top billing.

Mabwell, an innovative biopharmaceutical company with the whole industry chain layout, announced its Nectin-4 targeted site-specific ADC asset demonstrated promising clinical data.

Merck, known as MSD outside of the United States and Canada, and Eisai provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

Seagen Inc. (Nasdaq: SGEN) today announced that it will report its first quarter 2023 financial results on Thursday, April 27, 2023.

Following the U.S. Food and Drug Administration’s decision , Covis Pharma Group (“Covis”) is effectuating the withdrawal of Makena ® (hydroxyprogesterone caproate injection), which has been the only treatment approved to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.

Oncocyte Corporation (Nasdaq: OCX), a precision diagnostic company, today announces the peer-reviewed publication of the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer (mCRC).