Regulation

Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat to treat epithelioid sarcoma

Epizyme announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.

Keytruda, Lenvima combo gets FDA breakthrough designation for unresectable HCC

Merck and Eisai have been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Keytruda and Lenvima combination for unresectable hepatocellular carcinoma (HCC).

Pfizer gets FDA nod for biosimilar to Roche’s cancer drug Rituxan

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Ruxience (rituximab-pvvr), a biosimilar to Roche’s cancer drug Rituxan (rituximab), to treat certain cancers and autoimmune conditions.

FDA approves Baxter’s IV insulin Myxredlin

Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Myxredlin (insulin human in 0.9% sodium chloride injection).

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.