Research & Development

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.

Boehringer and Combotope partner for cancer antibodies

Boehringer Ingelheim has signed a research collaboration agreement with Combotope Therapeutics to advance tumour-selective antibody therapies targeting cancer.

Haisco and Nuvectis sign licensing deal for two drugs

Haisco Pharmaceutical Group has signed an exclusive licensing agreement granting US-based biotechnology company Nuvectis rights for two drug candidates in oncology and complement indications.

Genprex’s Reqorsa combo secures Canadian patent for lung cancer

Genprex has received a notice of allowance from the Canadian Intellectual Property Office (CIPO) for a patent related to the use of its Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with either programmed cell death protein 1 (PD-1) or PD-L1 antibodies to treat non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).