News Archive

USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster   Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.

To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.

The AIM-HI Women’s Venture Competition, in its third year, is open for women entrepreneurs! The program provides early-stage funding, coaching, and networking opportunities to women-led oncology startups to address unmet medical needs.

The winning company will receive a total of $1 million in equity investment from AIM-HI and co-investors, subject to due diligence and negotiation. Click here to download the flyer and help spread the word!

Marty Rosendale, Chief Executive Officer of the Maryland Tech Council, joins BioTalk to discuss MTCs Programs, Accessing Capital, and Goals for 2022

Listen now on Google https://bit.ly/3LQZNLR, Apple https://apple.co/3H6Aly4, Spotify https://spoti.fi/3LQkZRW, and Amazon https://amzn.to/3sZxuSR, and TuneIn https://bit.ly/3sU6Af0.

In this issue of Cell Host and Microbe, Haslwanter et al., 2022 present a comprehensive investigation into the molecular and functional basis of 17D vaccine responses and into differences between antibody neutralization of the 17D and related African lineage strains to contemporary Central/South American strains, including the emergent YFV ES-504 strain.

Image: https://www.cell.com

Sparking innovation at a Big Pharma with a 150-year history can be difficult, so sometimes it takes some outside perspective to get the ball rolling. That’s where Leaps by Bayer comes in.

Bayer’s venture arm has invested more than $1.5 billion from the balance sheet in the past six years to make bets on disruptive technologies.

Image: Jürgen Eckhardt, M.D., is the head of Leaps by Bayer, the Big Pharma’s venture investing arm. (Bayer)

This week, HealthLeaders speaks with Ricardo Johnson, CEO of Healthworx—the innovation and venture capital (VC) arm of CareFirst BlueCross BlueShield. Johnson details the plan’s approach to venture decisions and how the best investments are those that increase equity and affordability while benefiting the entire healthcare delivery system.

WILMINGTON, Del.–(BUSINESS WIRE)–Amalgam Rx, Inc., a leader in connecting healthcare providers, payers, and life sciences companies through a SaaS-enabled digital marketplace and product platform, and Privia Health Group, Inc., a national physician enablement company, announced a collaboration for multiple EHR-integrated services.

Leveraging Amalgam’s real-time, point-of-care decision support engine, the companies are working together to simplify and enhance the way providers practice value-based care, recruit for clinical trials, and ensure medication safety. Privia Health selected several offerings from Amalgam’s marketplace including:

Image: https://www.businesswire.com

The University of Maryland named Dr. Dean Chang as its new interim chief innovation officer and associate vice president for innovation and economic development of the research division, according to an email Monday from the interim and incoming vice presidents for research.

Chang served as founding associate vice president for innovation and entrepreneurship for this university’s Academy for Innovation and Entrepreneurship over the last nine years. In the position, he worked with more than 41,000 students in all 12 of the university’s colleges and schools in innovation, the email said.

Image: As the interim chief innovation officer, Dean Chang will oversee the Discovery District. (Jordyn Salow/The Diamondback)