News Archive

WASHINGTON, D.C. – The Senate Health, Education, Labor and Pensions Committee today passed S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The legislation is the Senate’s version of user fees reauthorization, including the Medical Device User Fee Amendments agreement (MDUFA V) between the medical technology industry and the FDA. The Senate committee action follows full House of Representatives passage of its version of the legislation last week. Scott Whitaker, president and CEO of AdvaMed, the world’s largest trade association representing medical technology companies, made the following comment on the Senate committee work.

“A well-functioning user fee system is essential to help ensure FDA’s timely review of innovative medical technology for patients. AdvaMed appreciates the timely work of each chamber of Congress to reauthorize this critical system with improvements to make the process better. MDUFA V has historic firsts, including provisions for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.

Antimicrobial resistance (AMR) is named one of the top 10 global health threats facing humanity by the World Health Organization and was associated with nearly 5 million deaths in 2019. With a challenge of this magnitude, it’s critical to have visibility in the supply chain for antimicrobials—medicines used to prevent and treat infections that include antibiotics (also known as antibacterials), antifungals, antivirals and antiparasitics.

Synexa Life Sciences (Synexa), a global leader in clinical biomarker and bioanalytics research services, recently secured 5,000 square feet of lab space in Rockville, Maryland. The new lab will be located within Inotiv, Inc.’s (Inotiv) Rockville site and is part of a new partnership between Synexa and Inotiv, a leading contract research organization.

For more than 20 years, Synexa has been delivering expert clinical development insights to life sciences organizations via biomarker and bioanalytics solutions, novel modality analytics, innovative technology platforms and custom assay development and validation. The new Rockville lab adds to the company’s global footprint that, up until very recently, included locations in Leiden, The Netherlands, Dublin, Ireland, Berlin, Germany, London, England and Cape Town, South Africa.

Image: https://biobuzz.io/

What a roller coaster. After stomach-clenching drops in 2020, the Washington, D.C., area market clambered up to new heights in 2021. Multifamily rents rebounded in and outside the District, development flourished in suburban downtowns and along the D.C. waterfront, and a stream of new life sciences tenants populated the I-270 corridor.

Still, while renters and tourists have largely returned, the office population has not, as wave after wave of COVID infections delayed a fuller return to office, leading to what now appears to be a permanent shift. In addition, 2022 brought with it new concerns about inflation, rising costs of capital, and an economic pullback in some areas.

Image: https://commercialobserver.com

SAN DIEGO — (June 14, 2022) — The licensing of university and nonprofit research has made a significant contribution to US gross domestic product (GDP), industrial gross output, and jobs over the last 25 years and underscores the importance of basic and applied research to the US economy, as well as the demand for public-private partnerships. The findings are based on an independent study released today and commissioned by the Biotechnology Innovation Organization (BIO) and AUTM, a global nonprofit that works to advance ideas from research institutions into the marketplace.

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient’s age.

Children’s National Hospital in Washington, D.C., was ranked #5 nationally in the U.S. News & World Report (USNWR) Best Children’s Hospitals annual rankings. It’s the sixth straight year has been in the top 10. Also for the 6th straight year, Children’s National’s neonatology program was ranked No. 1 among all children’s hospitals in the nation. Children’s National’s neurology and neurosurgery program is ranked the best in the Mid-Atlantic for a second year in a row.

Image: https://www.washingtonian.com

The biopharma bear market has ended the financing boom of recent years and led the valuations of companies to plunge after years of soaring—conditions that may compel smaller biotechs to pursue merger-and-acquisition (M&A) deals with pharma giants, according to a recently released report.

The challenges to valuations and access to capital come as the industry and the rest of the world move beyond the COVID-19 pandemic, EY, the professional services firm formerly known as Ernst & Young, observed in the 32nd annual edition of its “Beyond Borders” report.