Drug Filing

Janssen files for EMA approval for subcutaneous use of daratumumab

Johnson & Johnson’s Janssen Pharmaceutical is seeking extension of approval in the European Union for Darzalex (daratumumab) in a subcutaneous formulation for the treatment of multiple myeloma.

Novartis’ crizanlizumab secures FDA priority review for sickle cell disease

Novartis has secured priority review status from the US Food and Drug Administration (FDA) for its humanized anti-P-selectin monoclonal antibody crizanlizumab (SEG101) for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer

AstraZeneca’s oncology immunotherapy Imfinzi (durvalumab) has been granted orphan drug designation (ODD) for the treatment of small cell lung cancer (SCLC).

FDA accepts to review Sanofi’s multiple myeloma candidate isatuximab

Sanofi said that its biologics license application (BLA) for isatuximab for the treatment of relapsed/refractory multiple myeloma (RRMM) has been accepted for review by the US Food and Drug Administration (FDA).

Puma Biotechnology submits sNDA to FDA for Neratinib to treat HER2-positive metastatic breast cancer

Puma Biotechnology has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).

Sensorion receives EMA agreement on the pediatric investigation plan for Arazasetron in two indications

Sensorion (Paris:ALSEN)(FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces today that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for both development in the treatment of severe hearing loss (SSNHL) and for prevention of ototoxicity caused by cisplatin (CIO) in the pediatric population.

CHMP recommends EU approval of Roche’s Tecentriq plus Abraxane for metastatic TNBC

Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.

Tesaro’s niraparib secures FDA priority review for late stage ovarian cancer

Tesaro, a GlaxoSmithKline (GSK) company, has secured priority review designation for its polymerase (PARP) inhibitor ZEJULA (niraparib) from the US Food and Drug Administration (FDA) for the treatment of late stage ovarian cancer.

Alexion gets FDA priority review for Ultomiris to treat atypical hemolytic uremic syndrome

The US Food and Drug Administration (FDA) has accepted Alexion Pharmaceuticals’ supplemental biologics licence application (sBLA) for priority review of Ultomiris to treat people with aHUS and inhibition of complement-mediated thrombotic microangiopathy (TMA).