Research & Development

US FDA rejects approval of Unicycive’s kidney disease therapy

The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

Eli Lilly and Innovent agree Verzenios commercialisation deal in China

Eli Lilly and Company has entered into an agreement with Innovent Biologics for the commercialisation of Verzenios (abemaciclib) in mainland China.

Zymeworks agrees to buy Theravance Biopharma for $929m

Canadian biotechnology company Zymeworks has signed an agreement to acquire Theravance Biopharma in a cash transaction valued at approximately $929m (C$1.32bn).

FDA issues complete response letter to Sobi’s NASP for gout

Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.

Lilly’s Jaypirca receives CHMP positive opinion for CLL in Europe

Eli Lilly and Company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jaypirca (pirtobrutinib) to treat chronic lymphocytic leukaemia (CLL) in adults.

Immunai and Boehringer partner to identify T-cell targets

Immunai and Boehringer Ingelheim have entered a multi-project collaboration to identify new T-cell targets in oncology and autoimmune diseases.

Ionis grants Recordati rights to zilganersen for Alexander disease

Ionis Pharmaceuticals has entered a licence agreement granting global pharmaceutical company Recordati exclusive rights to develop and commercialise zilganersen to treat Alexander disease (AxD) in countries outside the US.

MSD’s Keytruda-Padcev combo secures EC approval for MIBC

The European Commission (EC) has approved Merck & Co’s (MSD) Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC).

RQ Bio secures $115m to develop influenza antibody programme

UK-based RQ Bio has closed a £85.5m ($115m) Series A funding round to advance its long-acting antibody therapeutic programme RQB01, which targets influenza prevention in high-risk and immunocompromised groups.