Regulation

FDA accepts Samsung Bioepis’ BLA for Humira biosimilar

The US Food and Drug Administration (FDA) has accepted for review Samsung Bioepis’ Biologics License Application (BLA) for SB5, a biosimilar for HUMIRA (adalimumab).

Myelo’s acute radiation syndrome therapy gets FDA orphan drug status

Myelo Therapeutics’ orally applied new chemical entity Myelo001 has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of acute radiation syndrome (ARS).

CHMP issues positive opinion supporting Trelegy Ellipta’s use in broader group of COPD patients

GlaxoSmithKline (GSK) and Innoviva secured positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the expanded use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol FF/UMEC/VI) in moderate to severe chronic obstructive pulmonary disease (COPD).

Novartis plans to file for new Lucentis indication in ROP

Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.

Mylan, Fujifilm Kyowa get EC nod for Humira biosimilar Hulio

Mylan and Fujifilm Kyowa Kirin Biologics have secured marketing authorization from the European Commission (EC) for their Hulio, a biosimilar to AbbVie's Humira (adalimumab), for all indications.

ACCC clears merger of generic pharmaceutical firms Arrow and Apotex

The Australian Competition and Consumer Commission (ACCC) has decided not to oppose the merger of generic pharmaceutical companies Arrow and Apotex after finding that the transaction would not reduce competition in any market.

OBI Pharma’s OBI-3424 gets FDA orphan drug status to treat ALL

OBI Pharma’s small-molecule prodrug OBI-3424 has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute lymphoblastic leukemia (ALL).

Cellectar gets FDA rare pediatric disease designation for CLR 131 to treat osteosarcoma

Cellectar Biosciences has secured rare pediatric disease designation (RPDD) from the US Food and Drug Administration (FDA) for its phospholipid drug conjugate (PDC) product candidate CLR 131 to treat rare pediatric cancer, osteosarcoma.

FDA approves Teva’s Ajovy for preventive treatment of migraine

Teva Pharmaceutical Industries has secured approval for its AJOVY (fremanezumab-vfrm) injection from the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults.