EVERSANA, a US-based company involved in providing commercial services to the global life sciences industry, and Accord BioPharma, the United States specialty division of Intas Pharmaceuticals, Ltd., announced on Wednesday that they have collaborated to support the introduction of CAMCEVI (leuprolide) 42mg injection emulsion to treat advanced prostate cancer in adults.
CAMCEVI's US distribution is headed by Accord BioPharma. Foresee Pharmaceuticals received approval from the United States Food and Drug Administration (FDA) for CAMCEVI's New Drug Application (NDA).
EVERSANA said that CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide for subcutaneous injection that is available in a pre-filled syringe with no mixing needed. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, the product provided consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48. The product should not be used in patients with hypersensitivity to GnRH or GnRH analogues due to possible anaphylactic reactions.
Galderma receives FDA Complete Response Letter for RelabotulinumtoxinA US filing
AbbVie receives positive CHMP opinion for upadacitinib in severe alopecia areata
AbbVie receives positive CHMP opinion for upadacitinib in non‑segmental vitiligo
genedrive partners with Thermo Fisher Scientific to develop high-throughput CYP2C19 test
Anivive Lifesciences' Laverdia receives FDA approval to treat canine lymphoma
Lupin's Enzalutamide Tablets receive for tentative US FDA approval
bioMérieux files FDA application for rapid vaginitis diagnostic panel
Ionis licenses ex-US rights to zilganersen for Alexander disease to Recordati
Dicot Pharma receives FDA clearance to start Phase 2b study of LIB-01 in US
CeleCor Therapeutics submits final section of zalunfiban (Disaggpro) New Drug Application to US FDA
Thalia Therapeutics acquires Sanmirna and raises GBP2.75m to advance AML RNA therapy
ZETA SURGICAL reports first patient treated with Zeta TMS Navigation System at HOPE Therapeutics