Oncology

FDA grants breakthrough therapy status for Cellectar’s iopofosine I 131

Cellectar Biosciences has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for iopofosine I 131.

Mabwell’s Mailisheng receives NMPA marketing approval

Mabwell has announced that its Albipagrastim alfa for Injection (Mailisheng) received marketing approval from the National Medical Products Administration (NMPA).

Archeus Technologies partners with WARF to advance ART-101 for prostate cancer

Archeus Technologies has announced a strategic collaboration with the Wisconsin Alumni Research Foundation (WARF) to advance ART-101 for prostate cancer.

FDA grants fast track status to Zai Lab’s lung cancer treatment

The US Food and Drug Administration (FDA) has granted fast track designation to Zai Lab’s delta-like ligand (DLL3) antibody-drug conjugate (ADC), ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC).

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.

FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG

BrainChild Bio's B7 homolog 3 (B7-H3) targeting autologous chimeric antigen receptor (CAR) T-cell therapy, BCB-276, has received the regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for treating diffuse intrinsic pontine glioma (DIPG).

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).

CHMP endorses Roche’s breast cancer therapy for administration out of clinical settings

Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.

Er-Kim to distribute Puma’s Nerlynx in Central Asian, Eastern European countries

Pharmaceutical company Er-Kim has entered into an agreement with Puma Biotechnology for the distribution of the latter’s Nerlynx (neratinib), aimed at treating breast cancer, in certain Central Asian and Eastern European countries.