Oncology

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.

SN Bioscience’s SNB-101 received FDA orphan drug designation

The US Food and Drug Administration (FDA) has granted orphan drug designation to SN Bioscience's SNB-101, a polymer nanoparticle anticancer drug to potentially treat pancreatic cancer.

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.

Japan grants priority review for Astellas’ urothelial cancer regimen

Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for Astellas Pharma’s supplemental new drug application (sNDA) for PADCEV (enfortumab vedotin) and KEYTRUDA (pembrolizumab) combination to treat urothelial cancer.

ProfoundBio secures $112m to advance ADC portfolio for cancer

Clinical-stage biotechnology company ProfoundBio has secured $112m in a Series B financing round to advance its clinical-stage antibody-drug conjugate (ADC) pipeline for cancer treatment.

Samsung Biologics and LegoChem enter ADC development deal

Contract development and manufacturing organization (CDMO) Samsung Biologics has entered into a strategic partnership with LegoChem Biosciences to advance antibody-drug conjugate (ADC) programmes aimed at treating solid tumours.

Zuellig Pharma acquires Cialis and Alimta brands from Lilly

Asian healthcare solutions company Zuellig Pharma has concluded the acquisition of Cialis (Tadalafil) and Alimta (Pemetrexed) brands from Eli Lilly and Company.

US FDA grants orphan drug status for Rznomics’ HCC treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for South Korean biopharmaceutical company Rznomics’ RZ-001 to treat hepatocellular carcinoma (HCC).

US FDA grants ODD to NeoImmuneTech’s NT-I7 for pancreatic cancer treatment

NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.