Rocket gene therapy rejected by FDA over manufacturing
Bio Pharma Dive
JUNE 28, 2024
The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.
Manufacturing Related Topics 
174 
Medical packaging companies in pharmaceutical contract manufacturing
Pharmaceutical Technology
JUNE 25, 2024
Discover the critical factors in choosing medical packaging companies for pharmaceutical contract manufacturing. Ensure quality with our guide.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 24, 2024
Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.
Gene therapy biotech Jaguar spins out manufacturing company
Bio Pharma Dive
JANUARY 18, 2024
Called Advanced Medicine Partners, the new company will offer specialized cell and gene therapy manufacturing services to biotech and pharma clients.
Making the Case for Case Management for Cell and Gene Therapies
Advertisement
A dedicated Case Manager provides end-to-end supply chain management and 24/7 oversight and support to help ensure the seamless manufacturing and distribution of each therapy dose to every patient.
Emergent to sell US sterile manufacturing facility to Bora
Pharmaceutical Technology
JUNE 21, 2024
Emergent BioSolutions has agreed to divest its sterile manufacturing facility in Baltimore-Camden, Maryland, to Bora Pharmaceuticals.
Incannex partners with Catalent to manufacture psilocybin
Pharmaceutical Technology
MARCH 6, 2023
Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. It will also establish cGMP manufacturing of a drug product which will be utilised in future clinical trials.
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.
Let's personalize your content