Drug Manufacturing

Henlius receives ODD for HLX22 from European Commission

Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.

Orion partners with Shilpa Biocare for recombinant human albumin in Europe

Orion Corporation and Shilpa Medicare’s fully-owned subsidiary Shilpa Biocare, have entered into an agreement to commercialise recombinant human albumin in Europe.

Genentech gains FDA approval for diabetic retinopathy treatment

Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).

Juvenescence secures $76m funding to advance therapeutic pipeline

AI-enabled biotech company Juvenescence has announced the first close of its Series B-1 funding round, securing $76m to progress its therapeutic portfolio into clinical development.

Mirai Bio and Thermo Fisher to advance genetic medicine development

Mirai Bio has entered into a strategic partnership with Thermo Fisher Scientific to accelerate the development of genetic medicines.

Canadian research initiative secures grant for paediatric brain cancer

The University of Calgary and Alberta Children’s Hospital have secured C$68,000 ($48,694) from Brain Cancer Canada for a research initiative spearhead by Dr Patrick Sipila and Dr Aru Narendran, aimed at improving outcomes for children with aggressive brain cancers.

AbbVie and ADARx to develop siRNA therapeutics for multiple disease areas

AbbVie and ADARx Pharmaceuticals have announced a partnership and licence option deal for developing small interfering ribonucleic acid (siRNA) therapeutics targeting various disease areas such as immunology, oncology, and neuroscience.

FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome

Regenxbio has announced the acceptance of its biologics license application (BLA) by the US Food and Drug Administration (FDA) of its gene therapy clemidsogene lanparvovec (RGX-121) for review to potentially treat Mucopolysaccharidosis II (MPS II), also referred as Hunter syndrome.

InnoCare’s Mesutoclax obtains breakthrough therapy designation in China

InnoCare’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).