Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.
This is part 1 of a two-part article that describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services.
Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?
If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. However, separating the issues of counterfeit and substandard medications is a difficult proposition.
Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
In the case of mixing and blender equipment, two or more fundamentally different devices may present to be viable solutions and the only way to determine the best technology is by performing lab tests.
This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.
How factors such as R&D vs. production press as well as compaction dwell time can affect your scale-up.
Can performing tests and sharing outcomes help to build a common approach and standard that will begin to standardize this important containment protective measure?
There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary.
Sterolithography (SLA) 3D printing is available in three resolutions (normal, high, and micro) for a range of part geometries. Most parts can be built in normal resolution, but, high resolution may also be required.
