Embecta | MedPath

Roche to Acquire Poseida Therapeutics; Merck, AstraZeneca, and Novartis Report Pipeline Success

6 months ago

• Roche will acquire Poseida Therapeutics for $1.0 billion, expanding its CAR-T therapy portfolio, targeting hematological malignancies, solid tumors, and autoimmune diseases. • Merck's Winrevair phase III study met its primary endpoint, showing a statistically significant reduction in morbidity or mortality events in advanced pulmonary arterial hypertension. • AstraZeneca's Truqap, combined with Zytiga and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • Novartis received European Commission approval for Kisqali to treat HR+/HER2- early breast cancer patients at high risk of disease recurrence, based on the NATALEE phase III trial.

September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases

8 months ago

• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback. • Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data. • Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC). • Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.

Embecta's Tubeless Insulin Patch Pump Receives FDA Clearance for Diabetes Management

8 months ago

• Embecta Corp. secures FDA 510(k) clearance for its tubeless insulin patch pump designed for adults with type 1 and type 2 diabetes. • The system features a 300U insulin reservoir patch pump, lasting up to 3 days, and a Bluetooth-enabled controller with a color touchscreen. • Clinical feedback informed the design, ensuring the 300U reservoir meets the 3-day insulin needs of 64% of type 2 diabetes patients. • Embecta plans to develop a closed-loop system with an insulin dosing algorithm to further advance diabetes management.

FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump

9 months ago

• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. • Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. • Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.