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.
On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March.
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.
Phase I/II results described by one analyst as “stunning” put Vaxcyte Inc. in position for a phase III trial with VAX-31, the firm’s 31-valent pneumococcal conjugate vaccine candidate designed to prevent invasive disease. San Carlos, Calif.-based Vaxcyte’s shares (NASDAQ:PCVX) closed Sept. 3 at $110.15, up $29.39, or 36.4%, on positive top-line results from the study testing the safety, tolerability and immunogenicity of the product in 1,015 healthy adults ages 50 and older.
Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.
Researchers from Thomas Jefferson University and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) have published findings from preclinical studies of LASSARAB, a new rabies-based Lassa virus (LASV) vaccine candidate.
Diakonos Oncology Corp. has developed a process to manufacture dendritic cell vaccines that the company believes are substantially more potent than its predecessors.
Immorna Biotherapeutics Inc. has received a grant from the Bill & Melinda Gates Foundation to support the clinical development of JCXH-108, a monovalent respiratory syncytial virus (RSV) vaccine based on Immorna’s proprietary mRNA and ready-to-use (RTU)-lipid nanoparticle (LNP) technologies.
The efficacy of seasonal flu vaccines varies due to the ability of the influenza virus to mutate rapidly. The achievement of a universal flu vaccine conferring protection against all strains, including those with pandemic potential, for longer than a single season would provide a great benefit and has not yet been achieved.
Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.
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