Research & Development

Besins Healthcare boosts drug delivery portfolio with UniD deal

Besins Healthcare has expanded its pharmaceutical operations with the acquisition of Belgium-based UniD Manufacturing, which specialises in long-acting drug delivery technologies.

SK bioscience to lead Gates Foundation-funded ROTOR project

SK bioscience is set to lead the Gates Foundation-fundedResearch Optimization & Trial Outcome Recommender (ROTOR) project, an AI-based platform aimed at reducing uncertainty in vaccine-development decisions.

European Commission approves Novartis’ Itvisma to treat SMA

The European Commission has granted approval for Novartis’ Itvisma (onasemnogene abeparvovec) as a treatment for children two years and older, teenagers and adults who have 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene.

Insilico Medicine, Takeda partner on AI-driven drug discovery

Insilico Medicine has entered into a strategic collaboration agreement with Takeda to deploy its AI-based Pharma.AI platform in the discovery and development of drug candidates.

Inocras, AimedBio team up for cancer treatments

US-based precision medicine company Inocras has entered a strategic partnership with South Korean biopharmaceutical company AimedBio to enhance cancer drug development using whole genome intelligence.

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.