By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future.
This partnership has an initial seven-year term and represents a key component of Civica's manufacturing strategy.
By partnering with Thermo Fisher, Civica will begin to build its internal pipeline of medications for use in emergency and critical care in the United States.
To date, Civica has worked with multiple quality drug manufacturers that already have US FDA approved manufacturing facilities and capacity to produce Civica labeled drugs in an effort to get shortage medications to market immediately.
Initially the Thermo Fisher collaboration will focus on nine critical medications that have been in short supply or where the drug supply chain is fragile because there are too few manufacturers making these drugs.
Civica's hospital-led drug selection and medical trends advisory committees helped prioritize these medications for Civica's Research and Development efforts.
Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organisations passionate about improving healthcare.
To date, nearly 50 health systems are Civica members, representing more than 1,200 US hospitals and over 30% of all licensed US hospital beds. Civica currently has 18 medications in production and/or shipped for use in hospitals across the country.
Civica Rx was established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States.
It exists in the public interest as a non-profit, non-stock corporation committed to stabilising the supply of essential generic medications in a hospital setting.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval