In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
The BioWorld Biopharmaceutical Index (BBI) saw an 8.15% increase at the close of May, outperforming the Dow Jones Industrial Average, which rose by 2.64%, and the Nasdaq Biotechnology Index, which was up by 0.7%. The BBI previously showed a strong performance in Q1, followed by a dip for all three indices in April, before all rebounded in May.
Alzheon Inc. has raised $100 million in a series E financing round to push its oral drug candidate for early Alzheimer’s disease (AD), ALZ-801 (valiltramiprosate), through a late-stage, Apolloe4 study.
The annual Companies to Watch report, which was just released, looks closely at seven companies flying under the radar that are developing antibody-drug conjugates (ADCs) for treating cancer. Companies examined in the new report are Adcendo ApS, Araris Biotech AG, Go Therapeutics Inc., Heidelberg Pharma AG, Pheon Therapeutics Ltd., Tallac Therapeutics Inc. and Tubulis GmbH.
Biopharma deal value surged in May to $18.76 billion, up 23% from April's $15.28 billion. This increase follows March’s $8.29 billion and February’s $7.76 billion, although represents a decline from January’s $27.9 billion. The monthly average for 2024 stands at $15.64 billion, compared to the $18.14 billion monthly average in 2023. Meanwhile, the value of biopharma M&As rose to $4.75 billion in May, an increase from April’s $1.33 billion, which was the lowest figure in nearly a year.
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
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