Regulation

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 multiple sclerosis product Gilenya approved in China

The Chinese National Medical Products Administration (NMPA) approved Gilenya for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older.

Celgene gets FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Otezla (apremilast) 30mg twice daily (BID) to treat adult patients with oral ulcers associated with Behçet’s Disease.

LifeMax receives rare pediatric disease designation for LM-030 to treat Netherton Syndrome

LifeMax Laboratories, a private company focused on treating rare diseases with few or no therapeutic options, announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.

AHF calls on Gilead to set up fund for victims harmed by its TDF-based drugs

AIDS Healthcare Foundation (AHF) is calling on Gilead Sciences Inc., one of the largest manufacturers of HIV/AIDS drugs, to set up a $10 billion victim compensation fund for patients harmed after taking the drug maker’s TDF-based (tenofovir disoproxil fumarate) drugs as part of their treatment for HIV or AIDS or taken by uninfected individuals as part of the HIV prevention strategy known as pre-exposure prophylaxis or PrEP.

FDA approves Merck’s Recarbrio to treat complicated infections

Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

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).

Dicerna gets breakthrough therapy designation for DCR-PHXC to treat primary hyperoxaluria type 1

Dicerna Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted a breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1).