In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.

A new horizon may be opening up in low-grade serious ovarian cancer (LGSOC) with the advent of Verastem Oncology Inc.’s therapy pairing two small molecules: avutometinib (VS-6766), a kinase inhibitor that binds to and inhibits the kinase activities of RAF and MEK to block the signal transduction pathways they mediate; and defactinib (VS-6063), an inhibitor of FAK.

Alto Neuroscience Inc.’s start this spring of the phase II double-blind, single- and multiple-dose study to test the pharmacodynamics of ALTO-203 in major depressive disorder represents another stake planted in a notoriously difficult indication. But getting attention as well is the push by Los Altos, Calif.-based Alto in post-traumatic stress disorder (PTSD) with a separate compound.

Biopharma companies have announced additional layoffs and restructurings in the past few weeks, after more than 7,800 job cuts were reported by BioWorld this year through late April. Through mid-May, total layoffs in the biopharma sector have increased to 9,848.

Homerun success of Novo Nordisk A/S’ semaglutide, which recently became the U.S.’s biggest blockbuster drug, is serving as an “inflection point” for obesity therapeutics and fueling the drive for new and improved therapies, speakers said at Bio Korea 2024 on May 8.

In April, the value of biopharma deals climbed to $15.28 billion, increasing 84% from March’s $8.29 billion and also up from February’s $7.76 billion, though there was a decline from January’s $27.9 billion. This amounts to a monthly average of $14.86 billion in deal value for 2024, compared to the $18.14 billion monthly average in 2023. Meanwhile, the value of biopharma M&As dipped to $1.33 billion for the month, marking the lowest figure in nearly a year.

As South Korea’s Curocell Inc. looks to develop the country’s first homegrown CAR T-cell therapy, CEO Gunsoo Kim highlighted rising and falling trends in the global CAR T development space at Bio Korea 2024.