Ridgeback Biotherapeutics LP’s Ebanga is the first FDA-approved, single-injection Ebola treatment which is available in a lyophilized form.
GlaxoSmithKline Plc said an injection of the company’s cabotegravir drug given every two months, in combination with Johnson & Johnson’s rilpivirine, was recommended for approval to treat HIV infections by a panel of the European health regulator.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
Britain’s GSK said an injection of the company’s cabotegravir drug given every two months was found to be 65 percent more effective in preventing HIV infections than Gilead’s Truvada daily oral pills.
GlaxoSmithKline’s HIV business ViiV is within weeks of resubmitting the request for approval of the long-acting injection Cabenuva to the U.S. drug regulator.
Nexus Pharmaceuticals received U.S. Food and Drug Administration approval for the company’s New Drug Application for Emerphed, the first premixed ephedrine in a ready-to-use 50 mg/10 mL vial.
The U.S. Food and Drug Administration approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages 6 years and older. The expanded indication approved by the FDA applies to both type 1 and 2 diabetes. Previously, Toujeo was U.S.-approved only for adults aged 18 years and older.
Johnson & Johnson filed for an approval from European regulators for the company’s two-dose experimental vaccine to protect against Ebola.
The U.S. Food and Drug Administration approved Janssen’s Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis.
Health authorities in Democratic Republic of Congo will introduce a Johnson & Johnson Ebola vaccine in November 2019 in the country’s eastern provinces, to counter the current outbreak.