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emmes

APT – SCOPE Summit 2025: Emmes’ Peter Ronco on Small Biopharma & Clinical Trial Partnerships

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emmesIn 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.

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ChildrensVATech

Children’s National Hospital and Virginia Tech Expand Research Partnership to Advance Pediatric Health

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ChildrensVATechNewswise — 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.”

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Vanda

Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist

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VandaWASHINGTON and SAN DIEGOFeb. 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).

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supernus pharmaceuticals logo

Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease

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supernus pharmaceuticals logoROCKVILLE, 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.

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United Therapeutics logo

United Therapeutics Corporation Announces Full Enrollment of the TETON 1 Study of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis

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United Therapeutics logoOver 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).

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United Therapeutics logo

United Therapeutics Corporation Announces FDA Clearance of its Investigational New Drug Application for the UKidney Xenotransplantation Clinical Trial

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United Therapeutics logoSILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–()–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.

United Therapeutics expects the first xenotransplant in this trial to be performed around mid-year 2025.

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BarkTank

Georgetown Entrepreneurs Win $150,000 in Prizes During Annual ‘Bark Tank’ Pitch Competition

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BarkTankEight student teams on a mission to make a positive impact on society presented their startup ideas to a panel of expert judges during the Leonsis Family Entrepreneurship Prize “Bark Tank” Pitch Competition on Wednesday, January 22, 2025, at Georgetown University’s McDonough School of Business, taking home $150,000 in prizes. 

Inspired by the pitches, Ted Leonsis (C’77, P’14, ’15), founder, chairman, principal, and chief executive officer of Monumental Sports & Entertainment, and his family increased the competition’s prize pool to $150,000 – furthering the financial impact and growth opportunity for each of the finalists who took the stage. This year’s prize builds on the $5 million gift the Leonsis family provided last year, which ensures the Bark Tank Pitch Competition exists in perpetuity.

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Theradaptive

Theradaptive’s OsteoAdapt™ SP Launches in Maryland with First Patient Dosed and $1 Million MSCRF Grant Support

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TheradaptiveFREDERICK, Md.Jan. 30, 2025 /PRNewswire-PRWeb/ — Theradaptive, a Maryland-based, privately held, clinical-stage biologics company, today announced the initiation of patient dosing in Maryland for the ongoing OASIS Phase I/II clinical trial assessing OsteoAdapt™ SP, the company’s lead product for spinal fusion.

Two patients were treated at MedStar Health in Maryland by Dr. David A. Weiner in January 2025, marking the first clinical cases in Maryland. This procedure is part of the company’s OASIS Phase I/II clinical trial, currently enrolling to measure the safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine. OsteoAdapt SP is designed with the goal of offering a promising alternative to current therapies while minimizing off-target effects, addressing both the efficacy and safety concerns related to existing standards of care. Theradaptive does this by utilizing a modified variant of recombinant human bone morphogenetic protein-2 (BMP-2), called AMP2, to stimulate the body’s stem cells for targeted bone regeneration. This method ensures targeted delivery of therapeutic benefits.

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MaxcyteSequre

MaxCyte® Acquires SeQure Dx to Broaden Cell Engineering Offerings with On-target and Off-target Editing Assessments

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MaxcyteSequreROCKVILLE, Md., Jan. 30, 2025 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing solutions to advance the discovery, development and commercialization of next-generation cell therapeutics announced today the acquisition of SeQure Dx, a market leader of on-target and off-target editing assessment services for cell and gene therapies.

This strategic acquisition strengthens MaxCyte’s ability to serve ex vivo and in vivo cell and gene therapy (CGT) developers with an innovative suite of tools and services spanning early R&D through clinical development and commercialization. By integrating SeQure Dx into MaxCyte, Maxcyte will expand its service offerings and leverage its commercial and field application scientist teams to work with developers earlier in their research processes. SeQure Dx is revenue generating and expected to be accretive to MaxCyte’s revenue growth.

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ETClogo

citybiz: ETC Baltimore Marks Milestone with Opening of Venture Hub at Connect Labs Baltimore

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ETClogoETC Baltimore, dedicated to elevating Baltimore as a national leader in tech startups, announces the opening of its inaugural ETC Venture Hub at Connect Labs Baltimore in the newly constructed 4MLK Building in the University of Maryland BioPark. This milestone marks a significant step in Baltimore’s efforts to strengthen its ecosystem for life science startups and attract high-potential companies to the city.

The ETC Venture Hub at Connect Labs Baltimore is a dedicated space designed to provide early-stage life science companies with the technology, capital, talent and resources needed to successfully grow and scale. Offering desk space, expert support, and a collaborative community, the hub serves as a launchpad for startups. This is part of ETC’s broader strategy to establish multiple footprints throughout the city. By expanding its reach, ETC aims to create a more inclusive and robust entrepreneurial ecosystem, ensuring innovators in all areas of Baltimore have access to the tools and support they need to thrive.

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