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A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. Can patients really be confident in pharma supply chains? Why would a pharmacompany take risks like these?
The factory will be able to supply up to 500 million doses of mRNA shots a year, and cover the full spectrum of manufacturing from drug substance production through to full/finish and packaging, according to the company.
It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. We went back to what we do best … we engaged our network of companies. It’s not a coincidence that we now have over 2.3
Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. The sponsor-initiated IND is conducted by a pharmacompany seeking commercial approval.
The Philadelphia-based company said it had taken the decision to go down the biologics license application (BLA) route for Covaxin based on FDA feedback to the EUA data package it had submitted to the agency. Bharat has also reported data suggesting the shot is effective against the beta (B.1.351) 1.351) variant.
There is a huge opportunity for pharmacompanies to capitalise on by focusing on increased DEI in clinical trials. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. What comes next? About the interviewees.
While many pharmacompanies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.
Such deals are inked to allow companies to expand their respective technology / product portfolios, and gain additional capabilities related to subcutaneous biologics. Notably, technology licensing agreements emerged as the most popular type of partnership model adopted by stakeholders in the subcutaneous biologics market.
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