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August 1, 2023

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miRecule and Sanofi drive the emergence of RNA therapeutics for Rare Diseases

After the race to find a COVID-19 vaccine, researchers set off to explore other disease areas with similar RNA vehicles. miRecule, a US biotechnology company, is on a different path, leveraging advances in RNA therapeutics to find treatments for rare diseases.

Today, Sanofi and miRecule are joining forces to pioneer innovative approaches in rare diseases and drive the creation of new medicines for patients in need.

In 2022, Sanofi announced its partnership with miRecule, combining Sanofi’s experience and best practices with the biotech’s speed and ability to drive novel therapies forward. And according to miRecule CEO Anthony Saleh, we’ve only seen the beginning of the exciting potential of RNA therapeutics.

 “As we learn more about patient genetics and data analytics, we can more quickly design and discover new RNA therapies,” said Saleh.

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Emergent BioSolutions Awarded 10-Year BARDA Contract Valued at up to a Maximum of $704 Million for Advanced Development and Procurement of Ebanga™ Treatment for Ebola

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

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Baltimore's AsclepiX Therapeutics Raises $10 Million to Advance Clinical Study

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)

BALTIMORE, MD, July 26, 2023– AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor.

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Virginia Workforce Award to AMPEL BioSolutions

Virginia officials recognized AMPEL BioSolutions today for their dedication to identifying, training, and retaining STEM-trained workers, especially in the area of precision medicine.

The annual Virginia Talent + Opportunity (V-TOP) award is given on National Intern Day to employers who provide work-based learning opportunities, particularly to interns, who are essential to Virginia's economy and play a crucial role in developing the necessary skills for career success, as stated by Kirk Cox, President of VA Bus Higher Ed Council. Internships are the foundation for workforce development.

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Global Breakthroughs for a Healthier Future - Registration for the 9th Annual BioHealth Capital Region Forum Now Live

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme "Global Breakthroughs for a Healthier Future." After a period of remote events, we're thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

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Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year's Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Charlottesville's RIVANNA receives $30.5 million from BARDA to advance the Accuro XV musculoskeletal imaging system

CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.

"Completing our base-stage performance milestones ahead of schedule is a testament to our organization's dedication and commitment to healthcare innovation," said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV's product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort," added Le Roux.

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Virginia's Solar Biotech Acquires VC-Backed Digital Biotech Noblegen

NORTON, Va. and PETERBOROUGH, ON, July 25, 2023 /PRNewswire/ - Solar Biotech Inc., a Norton, Virginia-based provider of complete sustainable and scalable biomanufacturing solutions, continues to build out its vertically integrated organization by acquiring Noblegen, an advanced digital biology company based in Peterborough, Ontario, Canada.

Noblegen will now operate under the name Solar Biotech Canada, continuing as the organization's food-grade-certified (SQF9) biomanufacturing and research & development hub in Canada. The new company will leverage both partners' strengths in microbiology and biomanufacturing to offer revolutionary biotech and synthetic biology ("SynBio") solutions for a wide range of applications.

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United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

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Fierce Biotech: Previous Crab Trap Winner Galen Robotics nets FDA de novo clearance for ENT surgery helper

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

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Apply Now for the 6th Annual BioHealth Capital Region Investor Conference: Uniting Visionary Entrepreneurs and Pioneering Investors for Transformative Funding

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference's history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

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