Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-564 for the treatment of solid tumors.
Though data won’t be available for a few years, the disclosure in mid-July that Grifols SA completed enrollment in the phase III study called Sparta caused some ears to perk up in the alpha-1-antitrypsin deficiency (AATD) space, where a number of contenders are busy.
At least 64 biopharma companies have announced workforce reductions so far in 2023, resulting in 6,000 jobs lost in the industry. It is a clear indication of a continuing trend begun last year in which executives needed to rein in spending to keep innovative programs afloat.
Following the company’s COVID-19 manufacturing misstep, Emergent Biosolutions Inc. continued its struggle to rebalance as top-line data from a phase III study it participated in failed to hit its primary endpoints with statistically significant results. The data showed that adding anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients with symptoms for less than 12 days failed to provide clinical benefit when compared to standard of care plus placebo. The global, multicenter double-blind, placebo-controlled randomized study assessed the safety and efficacy of four immunoglobulin candidates, the SARS-CoV-2 immune globulin intravenous (human) (COVID-HIG) plus standard of care.
DUBLIN – Grifols SA is acquiring Gigagen Inc. outright by paying $80 million for the remaining 56% of the company’s equity it does not already own. Its total outlay comes to $115 million, as it had previously acquired a 35% stake in South San Francisco-based Gigagen back in 2017.