BioSpace News Archive

Perfecting microbial manufacturing processes means taming its greatest asset: speed. This rapid process for creating biologics also means a race against time, where success hinges on conquering three key challenges: designing a robust microbial strain, optimizing fermentation for industrial scale, and ensuring consistent high-yield product yield.

This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.

The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.

As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.

The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.

Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.