Clinical Trials Licensing Packaging Pharma Companies 
pharmaphorum
MAY 27, 2022
This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.
World of DTC Marketing
APRIL 12, 2021
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 pharma company take risks like these?
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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. million doses.”
pharmaphorum
MAY 26, 2022
Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.
Drug Discovery World
MARCH 29, 2023
Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.
pharmaphorum
AUGUST 25, 2021
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. Clinical teams were already developing what clinical trials could look like,” says Ratevosian. Working with governments.
Advarra
JULY 19, 2022
The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.
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