Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea.
Biopharma financing activity surged in the first eight months of 2024, reaching $77.5 billion, a 91.25% increase from the $40.52 billion raised during the same period in 2023. August saw a slight dip in funding, with $3.48 billion raised compared to $3.71 billion in July.
Biopharma IPOs have faced tough conditions in recent years, but 2024 is showing signs of improvement in terms of value, while stumbling on overall performance. IPO values remain significantly lower than the peak years of 2020-2021 and are still below collective values seen in 2014-2019, however, this year's value marks a recovery compared to the challenging environment of 2023.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
The U.S. FDA approved 17 drugs in July, down from 28 in June, which marked the third-highest month in BioWorld’s records. On average, the FDA approved approximately nearly 19 drugs per month so far in 2024, compared to 16 per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
In July, biopharma deal values surged to $20.68 billion, a 61% increase from June's $12.82 billion. The boost pushed the total deal value for the first seven months of 2024 to $119.99 billion, marking the highest amount raised through July in BioWorld‘s records.
Stocks tumbled on Aug. 5, with the Dow Jones Industrial Average falling more than 1,000 points amid a disappointing jobs report released by the U.S. Labor Department on Aug. 2. The BioWorld Stock Index, which tracks approximately 510 U.S. biopharma stocks, was up 17.27% for the year on July 26 before closing Aug. 5 up only 3.47%, representing a significant drop.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results.