Other Diseases

MinervaX collaborates with Wacker Biotech for GBS vaccine production

MinervaX, a Danish biotechnology company, has joined forces with contract development and manufacturing organisation (CDMO) Wacker Biotech for the manufacturing of MinervaX’s active protein ingredients for its Group B Streptococcus (GBS) vaccine.

Celltrion secures new public tenders for two biosimilars in Peru

Biopharmaceutical company Celltrion has solidified its presence in the Latin American pharmaceutical market with a series of successful public tender wins in Peru.

UK’s NICE recommends QUVIVIQ to treat chronic insomnia in adults

The National Institute for Health and Care Excellence (NICE) has recommended Idorsia UK’s QUVIVIQ (daridorexant) to treat chronic insomnia in adults.

Eli Lilly and Company completes acquisition of Versanis Bio

Eli Lilly and Company (Lilly) has completed the acquisition of clinical-stage biopharmaceutical firm Versanis Bio.

BioCryst signs agreement with Er-Kim Pharmaceuticals to commercialise ORLADEYO in Turkey

BioCryst Pharmaceuticals has signed a collaboration agreement with Er-Kim Pharmaceuticals for commercialising ORLADEYO (berotralstat) in Turkey.

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Intercept Pharmaceuticals gets ODD for fixed dose of OCA-bezafibrate to treat PBC

Intercept Pharmaceuticals has received orphan drug designation from US Food and Drug Administration (FDA) for the fixed-dose combination of obeticholic acid (OCA) and bezafibrate to treat individuals with primary biliary cholangitis (PBC).

Abliva’s NV354 receives ODD from US FDA

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease.

AcelRx Pharmaceuticals completes divestment of DSUVIA to Alora Pharmaceuticals

California-based AcelRx Pharmaceuticals has completed the divestment of DSUVIA to Alora Pharmaceuticals.