News

BALTIMORE, Jan. 23, 2025 /PRNewswire/ — LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has filed for CE Mark registration for Lumina.

Lumina is the first product from LifeSprout’s proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

“The CE-mark submission marks a significant milestone for LifeSprout and brings Lumina an important step closer to benefiting patients,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout and Associate Professor of Plastic and Reconstructive Surgery and Biomedical Engineering at Johns Hopkins.

GERMANTOWN, Md., Feb. 06, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it has filed for CE Mark registration for the Eversense^® 365 CGM system.

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.

In an interview with ACT Associate Editor Don Tracy, Peter Ronco, CEO, Emmes, discusses the “Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma” session.
ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma session. Can you provide a brief synopsis of what the session entailed?

Ronco: When we kicked off this morning, Andy Lee spoke in the main session about how he has leveraged Merck and their clinical trial development group to execute a portfolio of work. That model works well for Merck—they have the money and resources. However, many mid-sized and small biotechs don’t have that level of funding and can’t afford to hire thousands of CROs.

Newswise — Children’s National Hospital and Virginia Tech are expanding their research partnership, building on a successful collaboration established in 2019. This partnership will advance pediatric health through innovative discoveries and therapies with an initial focus on pediatric cancers, including brain tumors.

The partnership brings together Children’s National, ranked among the nation’s top pediatric hospitals by U.S. News & World Report, and Virginia Tech, a leading academic research institution. Together, they aim to deliver transformative advancements to enhance outcomes for children facing devastating diagnoses.

“Over the years, our partnership with Virginia Tech has demonstrated the power of combining top-tier research expertise with a shared commitment to improving pediatric health,” said Catherine Bollard, senior vice president and chief research officer and director of the Center for Cancer and Immunology Research. “This expansion underscores our belief that by working together, we can accelerate discoveries and develop life-changing therapies for children with cancer and other rare diseases.”

WASHINGTON and SAN DIEGO, Feb. 3, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).

ROCKVILLE, Md., Feb. 04, 2025 (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, announced today that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.

Over 100,000 patients in the United States have IPF, with only two approved therapies available that only slow the course of disease progression

Top line data expected in the first half of 2026

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The study will enroll an initial cohort of six end-stage renal disease (ESRD) patients, expanding to up to 50 participants, and is intended to support a Biologics License Application (BLA) with the FDA.