Oncology

FDA grants two designations for GenFleet’s drug candidate SLS009

Chinese biotechnology company GenFleet Therapeutics has received the US Food and Drug Administration (FDA) designations for its drug candidate SLS009 (GFH009).

Simcha Therapeutics signs license agreement with Janssen for DR-18

Clinical-stage immunobiology company Simcha Therapeutics has signed a licence and option agreement with Johnson & Johnson subsidiary Janssen Biotech for new decoy-resistant IL-18 (DR-18).

Eli Lilly concludes POINT Biopharma acquisition for $1.4bn

Eli Lilly and Company has concluded the acquisition of all outstanding shares of radiopharmaceutical company POINT Biopharma in a deal valued at nearly $1.4bn.

FDA grants priority review for Daiichi Sankyo-Merck’s lung cancer therapy

The US Food and Drug Administration (FDA) has granted priority review to Daiichi Sankyo and Merck’s biologics license application (BLA) for patritumab deruxtecan, to potentially treat non-small cell lung cancer (NSCLC) in adults.

AbbVie agrees to acquire ImmunoGen for around $10.1bn

AbbVie has signed a definitive agreement to acquire ImmunoGen, including its flagship cancer therapy ELAHERE (mirvetuximab soravtansine-gynx) in a deal that is expected to speed up the former’s commercial and clinical presence in the solid tumour segment.

Boehringer Ingelheim announces acquisition of T3 Pharmaceuticals

Boehringer Ingelheim has announced the acquisition of Switzerland-based biotech company T3 Pharmaceuticals in a deal valued at up to CHF450m ($509m).

BeiGene to acquire global license to Ensem Therapeutics’ CDK2 inhibitor

BeiGene has signed an agreement to acquire an exclusive worldwide license to Ensem Therapeutics’ cyclin-dependent kinase 2 (CDK2) inhibitor.

NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS

NeoImmuneTech has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug, NT-I7 (efineptakin alfa) (rhIL-7-hyFc), to treat Acute Radiation Syndrome (ARS), an acute illness.

Juventas receives NMPA market approval for cell therapy

CASI Pharmaceuticals’ partner Juventas Cell Therapy has received market approval from the China National Medical Products Administration (NMPA) for Inaticabtagene Autoleucel (CNCT 19).