News

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the achievement of two milestones for its xenotransplantation programs in September: the second transplant of a UHeart™ xenoheart into a living person, and a 61-day study of the UThymoKidney™ xenokidney and thymus in a human pre-clinical model.

United Therapeutics’ organ manufacturing efforts consist of seven investigational programs: xenoheart, xenokidney, xenothymokidney, regenerative lungs, 3D-printed lungs, 3D-printed livers, and 3D-printed kidneys. These groundbreaking programs are intended to address the ongoing shortage of transplantable organs for patients with end stage organ disease.

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Rockville, MD, September 22, 2023 — Luminoah, a MedTech startup located in Charlottesville, VA, dedicated to improving the lives of people requiring enteral feeding, emerged as the top company at the 8^th Annual Crab Trap Competition, held as part of this year’s BioHealth Capital Region Forum. The event, which took place on September 20th, showcased Luminoah’s innovative wearable system, designed to optimize compliance and clinical outcomes through the integration of durable medical equipment, consumable nutrition pouches, and remote patient monitoring.

Neal Piper, Founder & CEO of Luminoah, delivered an outstanding presentation highlighting the company’s groundbreaking technology. Luminoah’s wearable system represents a significant advancement in the field of enteral feeding, offering an innovative solution to enhance patient care.

Federal funding fosters development and commercialization of medical devices designed for children

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) — To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

Leadership team expanded with addition of Chief Corporate Development Officer, Ted Hibben, a 25-year venture-stage business development biotherapeutic industry veteran Total venture funding tops $50M to date

GERMANTOWN, MD / ACCESSWIRE / September 21, 2023 / Seraxis Inc., a cell therapy company developing a pancreatic organoid cure to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the closing of the second tranche of its inaugural VC round to bring total equity investment in the company to over $50 million. Frazier Life Sciences, Polaris Partners, Eli Lilly and the JDRF T1D Fund participated in the step-up triggered by Seraxis’ achieving the completion of preclinical milestones of Seraxis’ novel pancreatic organoids, SR-02.

Ronco’s Global Pharmaceutical Experience Will Support the Next Chapter of Emmes’ Growth and Technology Enablement

Rockville, MD, September 20, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Peter Ronco has been named Chief Executive Officer, effective immediately.

Mr. Ronco succeeds Dr. Christine Dingivan, who will serve as a senior advisor to Executive Chairman Sastry Chilukuri, and Emmes’ Board of Directors.

D.C.’s Nanochon LLC is raising $3.5 million to make it through the final leg of its journey to bring a 3D-printed knee cartilage implant to market.

The company has already raised $1.8 million toward the round, according to a Securities and Exchange Commission filing. The company said it plans to use the funds to begin human trials and ultimately get Food and Drug Administration approval for its 3D-printed implant.

Nanochon has raised $5 million since its founding in 2016 to fund the clinical trials needed to bring its medical device to market.

PQE Group is excited to announce the opening of its newest office in Montreal, Quebec, Canada, marking a significant expansion for the company. The expansion aims to provide enhanced services to both existing and potential clients across various regions in Canada. The Greater Montreal area, located along North America’s east coast, is renowned for its vibrant life sciences community, featuring prestigious universities, leading hospitals, and innovative life sciences companies. Notably, Quebec serves as a hub for the development and acceleration of artificial intelligence (AI), reflecting its forward-thinking approach to shaping the future. Canada’s expertise in AI, characterized by its high-quality research, skilled workforce, and contributions to AI innovation on a global scale, has been a key source of inspiration for PQE Group.

THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen’s acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.