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Cell & Gene Therapies: FDA Regulatory Considerations In 2024
The fact is that most in the biotech industry know that cell and gene therapies- CGT are regulated across the U.S. as biological products by the FDA’s Center for Biologics Research and Evaluation- BER and need approval of a...
Clinical Trials
Can Clinical Research Spectrum Make The Most of Gene Therapy
It is a well-established fact that gene therapy research happens to be booming. Since the U.S. Food and Drug Administration- FDA issued its first approval when it comes to gene therapy in 2017, oncology researchers have gone on to...
News
US Enacts Biosecurity Law Blocking Chinese Bio Company Deals
In March 2024, one of the biosecurity laws restricting transactions with Chinese bio companies happened to pass the U.S. Congress, and now the global contract development and production- CDMO companies happen to be trying to secure production facilities within...
Drug Research
Market Trends: Biologics Clinical Manufacturing CDMO Service
In the ever-changing pharma and biologics sector, the Biologics Clinical Manufacturing CDMO Service market has gone on to emerge as quite a prominent player in the global economy, thereby going ahead and also exhibiting noteworthy growth and at the...
Drug Research
CDMOs Offering Unique Options To Meet Cold Chain Demands
It is worth noting that the Cell and gene therapies- CGTs have gone on to show immense promise when it comes to treating diverse conditions, right from cancer to neurodegenerative diseases. But, alongside their potential perks, they go on...
News
Latest real-world evidence presented at WCO-IOF-ESCEO assesses how EVENITY can help to close the treatment gap in osteoporosis
UCB, a global biopharmaceutical company announced key findings from the first retrospective patient cohort study in Denmark to observe the characteristics of patients selected for romosozumab treatment in routine clinical practice. The data were presented as a poster presentation...
News
Qinecsa Solutions announces acquisition of Insife to expand its end-to-end pharmacovigilance technology solutions
Qinecsa Solutions (Qinecsa), specialists in technology-led end-to-end pharmacovigilance solutions, proudly announces its acquisition of Insife ApS (Insife), a well-established Danish-based software, technology, and consultancy firm specializing in developing revolutionary pharmacovigilance platforms. This acquisition is in alignment with Qinecsa’s vision,...
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