Licensing Marketing Packaging Pharma Companies 
World of DTC Marketing
APRIL 12, 2021
QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Can patients really be confident in pharma supply chains? Patients should be scared.
pharmaphorum
AUGUST 25, 2021
Jirair Ratevosian, executive director of global patient solutions and government affairs at Gilead Sciences, tells us how his company utilised previously developed partnerships and their knowledge of providing global access to HIV treatments to distribute Remdesivir. We went back to what we do best … we engaged our network of companies.
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pharmaphorum
OCTOBER 7, 2021
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.
pharmaphorum
JUNE 11, 2021
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.
pharmaphorum
MAY 27, 2022
There is a huge opportunity for pharma companies 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?
Drug Discovery World
MARCH 29, 2023
Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.
pharmaphorum
MAY 26, 2022
While many pharma companies 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.
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