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October 21, 2025

Phlow Corp. Selected by the U.S. Food and Drug Administration Commissioner’s First-Ever National Priority Voucher Pilot Program to Advance Manufacturing of a Critical Essential Medicine in America

RICHMOND, Va., October 16, 2025 – Phlow Corp., a leading American advanced pharmaceutical contract development and manufacturing organization (CDMO), today announced that the active pharmaceutical ingredient for ketamine will be included in the first-ever U.S. Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) Pilot Program. This designation recognizes Phlow’s leadership in advancing domestic manufacturing of essential and life-changing medicines in the United States.

BRAINBox Solutions Announces Publication in JAMA Network OPEN of Major Analysis of Initial HeadSmart II Trial Concussion Patients

RICHMOND, VA – October 17, 2025 ‐ BRAINBox Solutions today announced the publication in JAMA Network OPEN of a major analysis of the first 1,000 patients with suspected concussion (mild traumatic brain injury or mTBI) in its pivotal, HeadSMART II study of its initial test, BRAINBox TBI, for concussion diagnosis and prognosis. The analysis, the largest of its kind, identified patient characteristics at the first medical encounter shortly after injury that are associated with consequential, persistent (30-days) symptoms, setting the stage for its test for diagnosis and prognosis.


“mTBI is a potentially serious condition and distinguishing which patients with...

Connect with BHI at TEDCO’s 11th Annual Entrepreneur Expo

BioHealth Innovation, Inc. (BHI) is excited to participate in TEDCO’s 11th Annual Entrepreneur Expo, taking place on Tuesday, October 21, 2025, at The Hotel at the University of Maryland in College Park, MD. The Expo is one of Maryland’s premier gatherings for entrepreneurs and innovators, bringing together over 1,000 of the region’s top business owners, investors, legislators, and industry influencers for a full day...

University of Maryland, Baltimore and Axis Research & Technologies Announce Joint Venture to Build Nation's First AI-Powered Smart Surgical Performance Center

The University of Maryland, Baltimore and Axis Research & Technologies today announced a groundbreaking joint venture to establish the nation’s first AI-powered smart surgical performance center. The new Surgical Performance Center—powered by the University of Maryland School of Medicine and Axis —will set a new national standard for innovation in surgical training, performance, and patient care.


This 36,000 sq. ft. facility will unite the University of Maryland School of Medicine’s more than two centuries of medical education leadership with Axis’s national expertise in surgical...

Maryland’s Economic Vision for BioHealth with Commerce Secretary Harry Coker, Jr. on BioTalk

In this episode of BioTalk with Rich Bendis, Harry Coker, Jr., Secretary of the Maryland Department of Commerce, joins the podcast to discuss Maryland’s rising momentum as a global biohealth and technology leader. Secretary Coker shares his unique journey from the CIA, NSA, and White House to leading Maryland’s economic development strategy, highlighting the state’s strengths in life sciences, its appeal to global investors, and the importance of public-private partnerships in accelerating innovation.


Topics include Maryland’s recent recognition as a Top 3 biopharma hub, the decision to...

Merck Breaks Ground on $3 Billion Center of Excellence for Pharmaceutical Manufacturing in Elkton, Virginia

RAHWAY, NJ, Oct. 20, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the start of construction for a $3 billion, 400,000-square-foot pharmaceutical manufacturing facility at its Elkton, Virginia, site.


Merck’s investment in the Center of Excellence for Pharmaceutical Manufacturing is part of a more than $70 billion investment beginning in 2025 to expand domestic manufacturing and research and development — not including any future business development transactions in R&D — to drive its long-term growth and strengthen the status of the U.S. as a global leader in biopharmaceutical innovation.

Scanogen Receives FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay

BALTIMORE--(BUSINESS WIRE)--Scanogen Inc., a molecular diagnostics company pioneering next-generation technologies for infectious disease detection, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s rapid assay designed to identify bloodstream infection pathogens directly from patient samples.


The FDA’s Breakthrough Device designation recognizes technologies that have the potential to...

Welldoc Expands AI-Powered Cardiometabolic Platform to Include Chronic Kidney Disease and MASH Support

COLUMBIA, Md., October 15, 2025 — Welldoc®, a leading AI-powered health tech company pioneering cardiometabolic care, today announced the expansion of its platform to include comprehensive support for the management of chronic kidney disease (CKD) and metabolic dysfunction-associated steatohepatitis (MASH). This expansion reinforces Welldoc’s commitment to delivering holistic, evidence-based AI-driven solutions that address the complex, interconnected nature of cardiometabolic conditions.


Building upon its clinical foundation in...

Phlow Appoints Tim M. Mayleben as Chairman of the Board, Building on Bold Leadership and Expanding America’s Medicine Manufacturing Future

RICHMOND, Va, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Phlow Corp., a leading American pharmaceutical contract development and manufacturing organization (CDMO), today announced that current board member and former advisory board member Tim M. Mayleben has been appointed Chairman of the Board of Directors. Mayleben will assume his new responsibilities immediately as Phlow continues to accelerate its purpose of creating the future of how medicines are made and reclaiming America’s pharmaceutical sovereignty.

NextCure and Simcere Zaiming announce that the first patient has been dosed in the U.S. Phase 1 trial for cancer therapy SIM0505

BELTSVILLE, Md. and SHANGHAI, Oct. 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.

11/10 - SOPE Fireside Chat with Dr. Jing Bao: International Market Review


The Society of Physician Entrepreneurs is honored to introduce, Dr. Jing Bao, a truly global physician entrepreneur who embodies the convergence of clinical insight and business innovation across multiple continents.

With a foot planted in the dynamic landscapes of both the US and Asia, our speaker has a unique vantage point on the biopharmaceutical and medtech sectors. Through her extensive experience consulting with diverse companies in these key regions, as well as the thriving biotech hub of...