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?

Generic Drugs 187

Generic Drugs Manufacturing Production Drugs 187

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.

Vaccination 95

Vaccination Vaccine Manufacturing Packaging 95

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.

Vaccination 65

Vaccination Vaccine Clinical Trials Clinical Trials 65

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? About the interviewees.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

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. 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

Marketing 52

Marketing Licensing Licensing Manufacturing 52

Advarra

JULY 19, 2022

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 pharma company seeking commercial approval.

Packaging 52

Packaging Packaging Drugs Containment 52

Drug Discovery World

MARCH 29, 2023

The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. This looks like it may change shape in the future for the region, if the proposal put forward by the commission is adopted.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52