- Sustainability
- DE&I
- Pandemic
- Finance
- Legal
- Technology
- Regulatory
- Global
- Pricing
- Strategy
- R&D/Clinical Trials
- Opinion
- Executive Roundtable
- Sales & Marketing
- Executive Profiles
- Leadership
- Market Access
- Patient Engagement
- Supply Chain
- Industry Trends
FDA Clears Precision BioLogic’s Factor VIII Deficient Plasma with VWF For Sale in the US
The agency granted the treatment with 510(k) clearance.
Precision BioLogic's Factor VIII Deficient Plasma with VWF
The FDA granted 510(k) clearance to BioLogic’s CRYOcheck Factor VIII Deficient Plasma with VWF. This opens the pathway for the company to launch the product in the US.
"Precision BioLogic provides tools to help laboratory professionals make the best decisions, faster," says Paul Empey, the company's President and CEO. "CRYOcheck Factor VIII Deficient Plasma with VWF offers labs a readily available and reliable alternative to congenital FVIII deficient plasmas. In fact, the product has already gained significant traction within the hemophilia research and pharmaceutical manufacturing community."
The treatment is designed to be used in clinical laboratories to identify human plasma with factor VIII deficiency. CRYOcheck comes in a frozen format, which reduces preparation time and errors.
It has already launched in Canada, the EU, UK, Australia, and New Zealand.
Source
(Sept. 18, 2023); PR Newswire; Precision BioLogic's Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S.; https://www.prnewswire.com/news-releases/precision-biologics-factor-viii-deficient-plasma-with-vwf-now-fda-cleared-for-sale-in-us-301930398.html
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
