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October 10, 2023

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BioHealth Innovation, Inc. Announces Strategic Agreement to Provide ARPA-H with Entrepreneurs-in-Residence

ROCKVILLE, MARYLAND, October 5, 2023 – BioHealth Innovation, Inc. (BHI) is proud to announce a pivotal agreement with the Advanced Research Projects Agency for Health (ARPA-H) to provide Entrepreneurs-in-Residence (EIRs) in support of ARPA-H's mission. This collaboration aims to bolster the development and commercialization of transformative health solutions.

Under the agreement, BHI's EIRs will offer strategic guidance to ARPA-H Program Managers (PMs) in areas including technology development, intellectual property, and small business needs. They will assist in the development and execution of programs, evaluate partnership opportunities with government biomedical and health research agencies, and leverage industry associations to support funded performers.

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Amgen Completes Acquisition of Horizon Therapeutics PLC

Advances Amgen's Mission to Serve Patients With First-in-Class Rare Disease Medicines

THOUSAND OAKS, Calif., Oct. 6, 2023 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it has completed its acquisition of Horizon Therapeutics plc for $116.50 per share in cash, representing a transaction equity value of approximately $27.8 billion.

"Today marks an exciting milestone as we welcome Horizon employees to Amgen and begin working together to serve even more patients around the world suffering from serious illnesses," said Robert A. Bradway, Amgen's chairman and chief executive officer. "We have strong momentum in our core business and the addition of Horizon will further position Amgen as a leader across a broader range of diseases."

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Unveiling Key Insights with Pete Briskman: A Comprehensive Update on the BioHealth Capital Region

In the 9th Annual BioHealth Capital Region Forum, Pete Briskman, Executive Managing Director and Co-Lead for the Mid-Atlantic Life Sciences Practice, offered a thorough update on the BioHealth Capital Region (BHCR) and its significant strides in the life sciences sector.

BHCR’s Noteworthy Achievements:

  • Securing the #3 rank among Life Science Clusters.
  • Leading the nation in the number of biotechnology patents.
  • Holding a prominent third position in total NIH grant funding.
  • Establishing itself robustly as the third-largest science cluster.

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Navigating 2023’s BioPharma Clusters with Alex Philippidis

Alex Philippidis, Senior Business Editor of Genetic Engineering and Biotechnology News, for the 4th consecutive year, attended the 9th Annual BioHealth Capital Region Forum, presenting his expert insights into the “Top 10 U.S. BioPharma Clusters, 2023,” providing a detailed analysis and overview of the current state and future prospects of the BioPharma industry.

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Revisiting Rich Bendis’s Welcome at the 9th Annual BioHealth Capital Region Forum

In a year that underscored “Global Breakthroughs for a Healthier Future,” Rich Bendis, President and CEO of BioHealth Innovation Inc (BHI), extended a heartfelt welcome to attendees, marking the 9th consecutive year of the Annual BioHealth Capital Region Forum.

Take a moment to reflect on Rich’s thorough review of the region’s transformative journey from its inception to its present-day stature, proudly holding a #3 ranking in the GEN Top 10 BioPharma Clusters in the United States. This achievement is a testament to its prowess in NIH Funding, Venture Capital Funding, Patents, Lab Space, and Jobs.

Rich highlighted the global impact of the term “BioHealth,” which has become more woven into the fabric of health discussions and innovations over nearly a decade.

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Emmes Acquires VaxTRIALS

VaxTRIALS Adds a New Latin America Base and Greater Vaccine Research Depth

Rockville, MD, October 5, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the acquisition of VaxTRIALS. Headquartered in Panama City, Panama, VaxTRIALS’ 160+ staff members manage and monitor vaccine clinical trial activities throughout Latin America.

“Today’s clinical trials are both more complex and more global in nature than ever before,” said Emmes Executive Chairman Sastry Chilukuri. “Combining VaxTRIALS’ depth of expertise in Latin America and Emmes’ strengths, particularly in technology, biostatistics and data management, will give clients an unmatched partnership experience in conducting their clinical trials.”

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Maryland based United Therapeutics is leading a medical revolution

Imagine a world where unhealthy organs are replaced with transplants constructed with a 3D printer using the patient’s own cells. No more agonizing waits and desperate searches for a suitable donor organ, and, because the printed organs use cells from the patients themselves, no more fear of organ rejection. It might sound like science fiction set in the far off future, but thanks to the pioneering work of United Therapeutics , it may become a reality a lot sooner than you think, and it’s happening here in Maryland.

Co-headquartered in Silver Spring, United Therapeutics was founded in 1996 by Dr. Martine Rothblatt, a mom who wanted to save her 7 year-old daughter Jenesis who’d been diagnosed with a rare and serious disease called pulmonary arterial hypertension. Twenty seven years later, Jenesis has defied the odds and works at the company her mother founded to save her life.

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Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

GAITHERSBURG, Md., Oct. 3, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax's vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians' offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

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IndoUSrare Announces Bridging RARE Summit to Combat Rare Diseases by Fostering Cross-Border Collaborations, Data Sharing, and Clinical Trials

With an increasing number of U.S. biopharmaceutical firms feeling the financial constraints imposed by the Inflation Reduction Act (IRA) and subsequently shutting down or suspending their research programs in the rare disease domain, hundreds of millions of patients in both the U.S. and India face the grim prospect of not receiving a breakthrough treatment for their condition within their lifetimes. IndoUSrare, a US-based nonprofit committed to stanching rare diseases, launches the inaugural Bridging RARE conference to forge a path for affordable clinical innovation via strengthened Indo-US collaborations and more inclusive clinical trials for minimizing the devastating health consequences arising from this policy shift.

(HERNDON, Va.) October 10, 2023: Rare diseases, as defined by the World Health Organization (WHO), refer to some 10,867 medically significant conditions, each with a prevalence of one or less per 1,000 individuals. With only about 8% of them being treatable,1 rare diseases include congenital malformations, autoimmune disorders, lysosomal storage disorders, thalassemia, muscular dystrophies, and infrequent forms of cancer and infections. Despite substantial progress during the 40 years since the enactment of the Orphan Drug Act of 1983, which incentivized the U.S. private sector to develop 1,100 FDA-approved orphan treatments,2 the global thrust against rare diseases is on the verge of losing steam.

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Gain Therapeutics Announces Dosing of First Two Subjects in Phase 1 Clinical Trial of GT-02287, a Novel GCase-targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

First small molecule allosteric binder discovered with Gain’s computational drug discovery platform enters clinical development

BETHESDA, Md., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced dosing of the first two subjects in a Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease. The Company expects to complete this trial in the first half of 2024.

“Initiating first-in-human dosing with GT-02287 is an important milestone for Gain as we enter a new era as a clinical-stage company,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “I am very proud of the work accomplished by the entire Gain team to get us to this stage today, and we are eager to advance our understanding of the safety, tolerability and effect of GT-02287 in humans. This represents another major step forward toward providing a treatment for Parkinson’s patients and their families impacted by this devastating disease.”

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Welldoc Expands Chronic Care Digital Health Platform to Include Weight Management

Welldoc’s industry-leading holistic platform now incorporates AI-driven digital coaching and features specifically designed to support individuals throughout the complex journey of weight management

COLUMBIA, Md., October 4, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the expansion of its platform to support weight management. Welldoc’s comprehensive chronic care platform now provides multi-condition support across prediabetes, diabetes, hypertension, heart failure and weight management, along with integrated mental wellbeing and sleep apnea support. Welldoc’s weight management solution is currently available to all customers and will be launching in early 2024 with two of the leading health care companies in the U.S.

Nearly two-thirds of U.S. adults are overweight or obese, which increases their risk of developing chronic comorbid conditions like type 2 diabetes, hypertension, heart failure, and sleep apnea.  As part of Welldoc’s total health approach to chronic care, AI-driven, personalized digital coaching is available 24/7 to help individuals navigate weight management whether they are just beginning their weight management journey with lifestyle changes or are prescribed a GLP-1 medication. Welldoc enables individuals to understand and connect with their health data in a meaningful way, making the achievement of weight and overall health goals more attainable. Welldoc also provides clinical escalations and decision support for the care team when needed.

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

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 8th 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.

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