COVID-19

In the second part of In Vivo's series on mRNA manufacturing, we look at the technology behind the Moderna and Pfizer/BioNTech COVID-19 vaccines. Experts in the field are working on a variety of improvements that will enable quicker, cheaper, surer development and production of what could turn out to be a wide array of vaccines and therapeutics to be churned out by emerging mRNA platforms.

Although procedure volumes have mostly recovered from the shock of COVID-19 two years ago, the effects of the pandemic on the medtech sector and the economy overall will be felt for years to come. In recent analyst and sales and earnings presentations, CEOs of major medtech companies faced questions about how their company is handling these major "macro" issues.

In the first of a three-part series on the evolution of mRNA manufacturing, this article looks back to before the pandemic, when dogged mRNA researchers and entrepreneurs labored in obscurity pursuing the dream of revolutionizing health care by commandeering the body’s own protein building process to generate quicker, cheaper vaccines and therapeutics. Then the mRNA COVID-19 vaccines stunned the world.

Pfizer social media announcement that it’s seeking full approval for the oral COVID antiviral raise questions about where the line is on promotion versus other communications, FDA’s ability to regulate pharma on social media, and the unique considerations of promotion under EUAs.

BD CEO Tom Polen is at the bottom of the pyramid – it’s where he wants to be and is best positioned to continue the company’s transition to focusing on high-growth spaces, as set out in the BD2025 strategy.

In Vivo spoke with two company creators working in the biotech industry about their strategies for seeking new science and their funding philosophy when building the biotechs of tomorrow.

Among the highlights of MedTech Europe’s annual MedTech Forum are the “unfiltered” views offered by company CEOs on the entire range of issues that influence decision-making or will have an impact on business operations in the near term.

Compassionate use programs (CUP) are a developing field in Asian countries. In the majority of Asian states, the CU applies to Named-Patients Program (NPP). In the most countries, understanding of CUP for unapproved drugs is poor among the public, and even for professional communities. 

A turbulent 2021: we are now in our eighth year of reviewing R&D productivity and corporate growth of the top 30 biopharma companies. While 2021 was dominated by the COVID-19 pandemic, biopharma as a whole had a good but not great year.

A selection of articles you might have missed from April 2022, including exclusive interviews, an in depth look at the impact of COVID-19 on clinical trial trends, and the latest Rising Leaders series. 

Company strategies at improving diversity, equity and inclusion both within their organizations and in the clinical trials they conduct have differed, but building trust is a common theme.

As the world begins its transition into a post-pandemic existence, it becomes possible to look back on the past two years and begin to quantify the effects COVID-19 has brought. For the biopharmaceutical industry, clinical trials have been at the forefront.

Nigerian start-up 54gene seeks to be the first private sector enterprise bent on applying Africa’s rich genetic heritage to solve the world’s most intractable diseases – ethically, without boundaries, for all.

Keeping a strategic focus but pivoting to meet health care priorities on demand were qualities Align Technology’s EMEA managing director Markus Sebastian ensured were uppermost at the company during the COVID-19 pandemic.

Biogen, Amgen, Lilly and Genentech experts shared tales of impending stockouts, particularly for single-use assemblies, filters and resins, and some of the measures they took to prevent them from causing drug shortages.

The formulas for various COVID-19 vaccines remain shrouded in intellectual property protections – one of many factors preventing them from being manufactured in developing nations. Those in favor of upholding IP say that scrapping patents could stifle future innovation, but their opponents believe preserving COVID-19 related IP rights is limiting access to lifesaving medical tools.