admin

Washington D.C., Dec. 10, 2021 (GLOBE NEWSWIRE) — The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. In an unprecedented decision, the competition judges determined that all five finalists were deserving of a grant award and recognition for the potential patient benefit and commercial viability of their innovations. 

Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.  

Earlier this year, current NIH director Francis S. Collins, M.D., Ph.D., announced his decision to end his tenure as the NIH director by the end of the year, and his last day as director will be December 19, 2021.  Dr. Collins is the longest-serving, presidentially-appointed NIH director, having served three U.S. presidents over more than 12 years.

The United States Agency for International Development has awarded a $204 million extension to the Johns Hopkins Center for Communication Programs to continue Breakthrough ACTION, its flagship global social and behavior change project, through July 2025.

Started as a five-year, $300 million project in July 2017, Breakthrough ACTION has now worked in 42 countries in Africa, Asia, and Latin America to forge, test, and scale up new and hybrid approaches to social and behavior change. The project uses state-of-the-art, evidence-based tools and collaborations to encourage people to adopt healthy behaviors such as using modern contraceptive methods, sleeping under bed nets, or being tested for HIV. Breakthrough ACTION harnesses the power of communication to inspire long-lasting change and incorporates behavioral science approaches such as behavioral economics and human-centered design to improve programs.

Image: CENTER FOR COMMUNICATION PROGRAMS

A global center focusing on pandemic prevention and biodefense work will be in Rockville, county officials and partners in the project said Wednesday.

Connected DMV, a nonprofit that focuses on initiatives with government, private industry academia and community partners, will launch the center.

Monoclonal antibodies have become one of humanity’s most powerful, multi-use tools in biology and medicine. Once the field of immunology established that they could be produced to bind very specifically to almost any suitable substance, science has had a means of detecting and/or purifying those substances or, in the case of viruses, identifying the antibodies that will serve as effective treatments. And in these times of pandemic, tools to detect viruses such as SARS-CoV-2 at the point of care and produce novel vaccines are more important than ever. 

Image: Dr. James Crowe, Vanderbilt University Medical Center, Nashville, Tennessee

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

ROCKVILLE, Md., Dec. 08, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s Disease (PD).

Following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in November 2020 indicating that the NDA was not sufficiently complete to permit a substantive review. The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021

Rockville, Md. — Montgomery County is home to the new Global Pandemic Prevention and Biodefense Center launched by Connected DMV. The Center will be co-located in Rockville at the US Pharmacopeia offices at 12601 Twinbrook Pkwy, Rockville, MD 20852. 

Connected DMV, a leading Greater Washington organization that seeks to help solve complex regional challenges, spearheaded efforts to establish the Global Pandemic Prevention and Biodefense Center in response to the COVID-19 pandemic. The Center’s goal is to help prevent future outbreaks from becoming pandemics by developing a stockpile of human monoclonal antibodies in advance for emerging infectious diseases and by integrating antibody distribution and delivery across the global health and pandemic prevention ecosystem. Montgomery County is uniquely positioned to be the host location for the Center, which aims to harness the rich talent and critical health research, biotech, defense, and government assets required to deliver a full-scale response.

Our internal 24-hour circadian clock regulates many aspects of physiology, including the response to infectious disease and vaccination. A new study published in the Journal of Biological Rhythms demonstrates that antibody levels are higher when people receive the SARS-CoV-2 vaccine in the afternoon versus the morning.

Image: https://news.harvard.edu/