Regulation

FDA refuses to approve Regeneron’s Eylea pre-filled syringe

The US Food and Drug Administration has refused to approve Regeneron’s pre-filled syringe version of eye-drug Eylea (aflibercept).

FDA approves Roche’s Xofluza to treat influenza

Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat acute, uncomplicated influenza, or flu in people aged 12 years and older.

Eiger’s lonafarnib secures RPD designation from FDA to treat Progeria

Eiger BioPharmaceuticals has secured the Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for lonafarnib to treat both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies.

Vertex gets CHMP positive opinion for Kalydeco to treat CF in young children

Vertex Pharmaceuticals (Europe) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kalydeco (ivacaftor) to treat people with cystic fibrosis (CF) aged 12 to <24 months with certain mutations in the CFTR gene.

Kala Pharmaceuticals submits NDA to FDA for KPI-121 0.25% to treat dry eye disease

Kala Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for KPI-121 0.25%, a topical product candidate being developed for the temporary relief of signs and symptoms of dry eye disease.

AstraZeneca, Merck’s Lynparza gets FDA ODD for pancreatic cancer

AstraZeneca and Merck have secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to treat pancreatic cancer.

FDA panel recommends approval of Rituxan biosimilar

The US Food and Drug Administration’s (FDA) advisory committee has recommended approval of Celltrion and Teva Pharmaceutical’s biosimilar of Roche’s blood cancer drug Rituxan (rituximab).

Silence Therapeutics launches interim European injunction application against Alnylam’s Onpattro

Silence Therapeutics has received a notice of intention to grant for a new European divisional patent, EP 3 222 724B, and started a new cross-border interim injunction application in the Netherlands against Alnylam's Onpattro (patisiran).

FDA and EMA accept Novartis’ filings for MS drug Siponimod

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).