News Archive

The Gaithersburg biotech has had no product to market in its 35-year history.

The fourth annual HERstory Gala took place on Thursday, April 21, 2022 at the VisArt Studio in Rockville Town Square. This gala is the chapter’s premier event honoring outstanding women in biotech in the Washington DC metro region. Attendees included 85 members and supporters from diverse professional backgrounds, including science, marketing, legal, and entrepreneurship.

Image: https://www.womeninbio.org

Jun 7, 2022

Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee
If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S.
GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

“The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “In today’s VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision.”

Biotechnology firm United Therapeutics has showcased what it claims to be the “world’s most complex 3D printed object” in partnership with 3D printer manufacturer 3D Systems at the recent LIFE ITSELF conference in San Diego.

The partners have produced a 3D printed human lung scaffold capable of demonstrating gas exchange in animal models, and are now planning to cellularize the scaffold with a patient’s own stem cells to create tolerable, transplantable human lungs.

QIAGEN CEO Thierry Bernard joins Yahoo Finance Live to explain how his company is utilizing technology to track the spread of COVID through wastewater and also discusses how to track the monkeypox outbreak.

Accurately testing wastewater for COVID could help cities and towns prepare for outbreaks, stock up supplies, or put measures in place to prevent further community transmission of COVID-19. And one company recently receiving a nod from the CDC for wastewater testing is German company QIAGEN.

Health and Human Services Secretary Xavier Becerra appointed Adam Russell, Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as acting deputy director of the new Advanced Research Project Agency for Health (ARPA-H).

Proposed by President Joseph R. Biden to improve the U.S. government’s ability to speed biomedical and health research, ARPA-H was established by law on March 15 and will operate as an independent entity within the National Institutes of Health.

image: National Institutes of Health in Bethesda, Md.

Rockville, MD – On June 8th, Korea SMEs and Startups Agency (KOSME), its Korean Business Development Center (KBDC) and BioHealth Innovation, Inc. (BHI) will kick-off their second virtual US Market Entry program for Korean companies expanding to the United States.

Last summer, BHI and KOSME conducted a similar pilot program, which included five medical device and diagnostics companies.

This year’s competitively selected 5-member cohort includes medical diagnostics, medical devices, health AI and software companies. Over 25 Korea-based health-tech companies applied to the program.

The program will guide the cohort to adopt cultural business differences and communication methods, outline a go-to-market strategy, connect with strategic partners & key opinion leaders, and suggest product or prototype modifications. BHI’s Entrepreneurs in Residents (EIRs) mentor the cohort to achieve a successful US biohealth market entry.

image: KOSME President Hakdo Kim and BHI President Rich Bendis

Brian Castleberry, Maryland Department of Commerce Regional Manager – Middle East, Africa and India, Office of International Investment and Trade, and & Robin Wiener, President, Get Real Health, Join Rich Bendis on BioTalk to discuss International Collaborations, Maryland Biotech, and Collaborations.

Listen now via Google https://bit.ly/3xjyLau, Apple https://apple.co/3GU4UIP, Spotify https://spoti.fi/3MrBJ0R, Amazon https://amzn.to/3H0rL5F, and TuneIn https://bit.ly/38Ry0vV

Lung scaffolds developed in partnership with 3D Systems Corporation represent the most complex objects ever printed; reveal took place at the LIFE ITSELF Conference in San Diego

3D-printed lung scaffolds are demonstrating gas exchange in animal models

United Therapeutics expects human clinical trials of 3D-printed, cellularized lungs in the next five years

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & ROCK HILL, S.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that in partnership with 3D Systems Corporation (NYSE: DDD) it has produced the world’s most complex 3D-printed object – a human lung scaffold – and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare.