By Anastassia Gliadkovskaya - Dec 11, 2023 4:00pm - 

Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. 

The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization. 

“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.

BALTIMORE, Maryland, December 11, 2023 – GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in metastatic castration-resistant prostate cancer (mCRPC), MASH liver fibrosis, and type 2 diabetes (T2D), was recently awarded a two-year, $3.7 million Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, to advance their therapeutic pipeline.

Currently, there are no United States Food and Drug Administration-approved drugs for mCRPC patients who develop a resistance to second-line hormonal therapies, or for the treatment of liver fibrosis or lung fibrosis. GlycoMantra is working to develop a therapeutic that will halt or reverse these diseases. The Phase II SBIR award will support the Company’s development of mammalian cell lines, a master cell bank (MCB), and the cGLP manufacturing for this drug.

Are you ready to dive into the world of groundbreaking biotechnology and the fight against chronic diseases? In this episode of BioTalk with Rich Bendis, we bring you an enlightening conversation with Dr. Nehal Mehta, Founder and CEO of Mobius Scientific, Inc. Dr. Mehta is not only a distinguished Professor of Medicine but also a visionary entrepreneur on a mission to revolutionize healthcare.

Join us as we explore the journey of Mobius Scientific, an early-stage biotechnology company with a transformative approach. Mobius is developing cutting-edge biologic therapies targeting the root cause of chronic diseases, starting with lipid accumulation. This innovative platform has the potential to change the lives of millions suffering from debilitating conditions.

Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and, while less prevalent, also affects Hispanic Americans. The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body’s tissues. This mutation causes red blood cells to develop a crescent or “sickle” shape. These sickled red blood cells restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events or crises can lead to life-threatening disabilities and/or early death. 

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BALTIMORE, Dec. 7, 2023 /PRNewswire/ -- BioGenCell, a pioneer in personalized cell therapy solutions, is excited to announce the launch of its fifth Phase II clinical trial site in the United States at the University of Maryland. The trial is focused on significantly reducing the need for amputation in patients with Chronic Limb-Threatening Ischemia (CLTI). The University of Maryland has joined this ambitious, global, placebo-controlled trial designed to offer transformative results for patients.

The prognosis for CLI patients is currently disheartening: within a year of diagnosis, nearly 20% of patients succumb to the disease while 30% will undergo amputation. Tragically, nearly 70% of these amputees do not survive beyond five years post-amputation.

WASHINGTON, Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY^® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY^® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY^® has a proven safety profile with over 10 years of data.

"The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

ARPA-H made its final hub location decision, selecting the historic Bowen Building in downtown Washington, D.C. as the site for its Stakeholder & Operations hub.

Why is this important? The new space will allow federal staff and contractors to work in one location, enhancing staff's ability to manage programs and coordinate with federal partners—such as Congress, Health and Human Services, Centers for Medicare and Medicaid Services, U.S. Food and Drug Administration, the National Institutes of Health, and the Administration. Since the agency was authorized in March 2022, much of ARPA-H's D.C. staff has been working remotely or from temporary offices.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics (Nasdaq: UTHR), a public benefit corporation, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2024. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The list of awards was announced on December 6, 2023, is available on Newsweek’s website, and recognizes the top 600 most responsible companies in the United States, spanning 14 industries.

ROCKVILLE, M.D. and SUZHOU, China, Dec. 6, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announces the licensing deal expansion with Synaffix B.V., a Lonza company (SIX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index.

The expanded deal builds on a previous agreement signed in June 2021, under which Innovent is granted to deploy Synaffix's ADC technologies on a target-specific, non-exclusive basis, including GlycoConnect®, HydraSpace® and one of its toxSYN® linker-payloads, for a therapeutic molecule (Innovent R&D code: IBI343, a CLDN18.2 ADC) which has advanced to Phase 1 clinical development.

WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Danaher Corporation (NYSE:DHR) ("Danaher") announced today it has completed its acquisition of Abcam plc (NASDAQ:ABCM) ("Abcam").

The acquisition of Abcam for $24.00 per share in cash was implemented by way of a Court-sanctioned scheme of arrangement under the UK Companies Act 2006 (the "Scheme") and the Scheme became effective in accordance with its terms on December 6, 2023. As a result, Abcam has become an indirect wholly owned subsidiary of Danaher. Trading of Abcam ADSs on Nasdaq has been suspended.

A powerful web app to help drug designers accurately predict the pKa value of titratable residues

December 5, 2023, Baltimore, MD – ComputChem, an Early Charm company that develops computational chemistry software for drug design, has just launched its first product, iTitrate.

iTitrate is a web app that accurately predicts the pKa values of titratable residues by simulating an acid-base titration experiment. It computationally allows a protein to adjust its protonation and conformational states to solution pH. This state-of-the-art approach has been rigorously validated through references available on the ComputChem website.

By Pratik Jain and Khushi Mandowara - Dec 5 (Reuters) - Weight-loss drug developer Altimmune (ALT.O) is open to deals and collaborations with large drugmakers as it actively looks for partners to launch and develop its experimental obesity drug, CEO Vipin Garg told Reuters on Tuesday.

Upbeat mid-stage trial data for its obesity drug and recent multi-billion dollar deals by companies such as Roche (ROG.S) and AstraZeneca (AZN.L) to grab a slice of the fast-growing market have fueled hopes of Big Pharma scooping up the company.

Gaithersburg, Maryland-based Altimmune last week reported mid-stage trial data for pemvidutide that showed the drug helped reduce weight by 15.6% on average and continued weight loss at the end of treatment.

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The National Heart Lung and Blood Institute (NHLBI) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) will be providing training and resources for a new Innovator to Entrepreneur Program (ITEP). ITEP is designed to assist aspiring entrepreneurs by providing them with cohort-based training covering key elements of company launch, business strategy development, IP protection, market research, customer discovery, startup financing and SBIR/STTR grantsmanship.   

This new program encourages participation in the SBIR/STTR program by underrepresented groups, Women-Owned Small Businesses, socially/economically disadvantaged small businesses, and small businesses located in HUBZones programs.  

Attend the Informational Webinar on December 6th at 2PM ET to learn more about the new ITEP program. Information about ITEP is available on the ITEP website.  ITEP will begin accepting applications of interest on December 8th.  

MENLO PARK, Calif., Dec. 4, 2023 /PRNewswire/ -- Enavate Sciences, a portfolio company of Patient Square Capital, is pleased to announce that Sara M. Nayeem, M.D. has joined the firm as Executive Vice President, Investments. Dr. Nayeem reports to James Boylan, Chief Executive Officer of Enavate Sciences, and will serve an integral role in the origination, evaluation, and selection of Enavate investments, as well as support Enavate partner companies on governance, partnerships, fundraising, and other strategic initiatives.

Dr. Nayeem has 20 years of banking and institutional investing experience. She most recently served as Partner at Avoro Ventures, a biopharma venture fund she helped launch in 2021. Previously she was a Partner at New Enterprise Associates, Inc. (NEA), where she spent 12 years as part of the biopharma investing group. Prior to joining NEA, Dr. Nayeem was an Associate with Merrill Lynch's Global Healthcare Group, where she advised biotechnology and medical device companies. She began her career as an Investment Banking Analyst at Morgan Stanley.

AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition

BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development.

The Biological and Emerging Infections Research Resources Program (BEI-RRP) contract, which merges the two programs, represents the fourth recompete award with NIAID since 2003.

MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced a seven-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to continue the management of the BEI Resources Program. NIAID has made an initial award of over $21.5 million, with further funding expected if all project milestones are met. This contract will merge the NIH HIV Reagent Program with the BEI Resources Program under the Biological and Emerging Infections Research Resources Program (BEI-RRP) umbrella. ATCC has managed the BEI Resources Program since 2003 and the NIH HIV Reagent Program since 2020. This important merger will allow researchers to have streamlined access to all priority pathogens for human health under one program.

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD. This strategic move by 424 Capital aims to expedite positive clinical outcomes by enabling pharmaceutical and biotechnology organizations to focus on the research, development, and production of cutting-edge therapeutics in a compliant and effective manner.

Founded in 2001 by CEO Bill Robertson, VaLogic provides a comprehensive range of software and compliance services to the life science and biotechnology market. These services help organizations and facilities maintain GMP compliance and enact high standards while focusing on advancing life-saving therapeutics.

VaLogic offers advisory and facility design, full commissioning and qualification, cleanroom environmental monitoring, HEPA/cleanroom certifications, calibration, preventative maintenance, and a proprietary SaaS software called LogiPoint™ for continuous monitoring of critical facilities and equipment.

Richard Hughen’s thirty years of professional medical device experience spans three Fortune 500 and four start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up developing a novel continuous predictive respiratory monitoring device for the patient bedside and home. Ric was an investor and member of the executive team that built start-up CSA Medical, from a technology license (Navy) through product development, animal trials, clinical trials, five FDA clearances, CE mark, three rounds of funding ($50M), commercial growth and a 2019 sale to Steris. Ric was Managing Director of LearnWare, a life science focused e-learning start-up, which was successfully built and sold to a private equity fund.

He is currently a reviewer for the National Science Foundation’s SBIR/STTR program, an Entrepreneur in Residence for Johns Hopkins Tech Ventures and on the advisory board for George Mason University’s Bioengineering Alliance. He is founder of Life Science Planning, a strategic consultancy for life science companies with focus on fast paced start-up, early stage and emerging growth companies. Earlier in his career, Ric led various senior management, marketing, training and sales teams for Johnson & Johnson, BD, Abbott and Cordis. Ric holds MBA and BS degrees from The Pennsylvania State University. When not working, he is typically outside training for triathlon competition.

LEIDEN, the Netherlands, November 29, 2023 / B3C newswire / -- MIMETAS, a leader in human 3D disease modeling, and Yamaha Motor Co., Ltd., a developer of the CELL HANDLER™, announce a strategic joint marketing agreement aimed at advancing therapeutic development using human-relevant models throughout the early drug development pipeline. The collaboration combines MIMETAS’ comprehensive disease modeling and assay development expertise with Yamaha Motor's state-of-the-art CELL HANDLER, an automated system for selecting, picking and imaging spheroids, tissues and organoids.

Bas Trietsch, CTO of MIMETAS, emphasized the significance of this collaboration, stating, “Introducing patient-relevant 3D disease models into the drug development pipeline is key to developing new therapeutics for unsolved diseases. However, most of these models lack a vascular system and integrated immune cells, which are critical for studying disease processes and therapy efficacy. One of the primary challenges with complex biological models lies in the variability of growth rate and morphology, making high-throughput, robust assays challenging and time consuming. To address these challenges, state-of-the-art automation, such as the Yamaha Cell Handler, is critical.”  “By combining our technologies, we will improve the quality and robustness of tissue model applications in high-throughput,” said K. Matsuno, General Manager of Medical Device Business Division of Yamaha Motor.  “Together, we can make advanced 3D human disease models suitable for all stages of early drug development.”

ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE^® trial. RGX-202 is an investigational one-time AAV Therapeutic for Duchenne muscular dystrophy (Duchenne), using the NAV^® AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle-specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.

"Progressing to dose level 2 is an important milestone in our updated strategic plans and for accelerating the development of RGX-202," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "There is a large unmet need for new therapies for boys with Duchenne, and the market is capable of supporting multiple gene therapies. We believe RGX-202 has unique, differentiating features that support its potential to be a best-in-class product."

GAITHERSBURG, Md., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

BioHealth Innovation is thrilled to announce that our esteemed Entrepreneur-in-Residence, Kwame Ulmer, has been recognized by Quroba for his outstanding contributions to the MedTech industry. This recognition is a testament to Kwame's exceptional journey and his relentless pursuit of innovation in healthcare technology.

From Quroba's Post:

"This month, we're honored to shine the spotlight on a true industry luminary, our very own Kwame Ulmer.

With two decades of experience in evaluating medical technologies across both government and private sectors, Kwame's expertise is nothing short of exceptional.

COLUMBIA, Md. (November 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Social Impact Funds investment into NasaClip.

“Nosebleeds are common, and often don’t require medical intervention. In fact, with emergency treatment many patients end up walking out of the hospital later than anticipated and in more pain than when they entered,” said Dr. Elizabeth Clayborne, CEO and founder of NasaClip. “Thanks to TEDCO’s investment we can continue our efforts to provide a more timely, efficient and cost-effective solution for patients, allowing them to get treated from the comfort of their own homes.”

As the year 2023 comes to a close, CarrTech Corp has demonstrated remarkable progress and innovation in the biotechnology and medical device sectors. The company has achieved several milestones, engaged in significant collaborations, and is poised for further advancements in the coming year. Here are some of the key highlights from CarrTech Corp's journey over the past year:

GRAND RAPIDS, Mich., Nov. 27, 2023 /PRNewswire/ -- cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that they have made a significant investment into Nanochon, a Washington, D.C.—based regenerative cartilage innovator.  

Nanochon develops solutions utilized by sports medicine physicians to treat active patients requiring cartilage restoration.  Nanochon's Chondrograft™ replaces lost or damaged cartilage and encourages new growth using an innovative material and 3D printed designs that are cost-effective and easy to deploy treatment options.

What is the dynamic synergy between pioneering science and transformative industry developments? Join us in this episode of BioTalk with Rich Bendis for a thought-provoking conversation about the work of Blackbird Laboratories. Our guest, Matt Tremblay, Ph.D., Chief Executive Officer of Blackbird Laboratories, sheds light on their role in fostering innovation within the vibrant BioHealth community of Baltimore and the wider BioHealth Capital Region.

Blackbird Laboratories recently launched with a significant $100 million founding grant from The Stephen and Renee Bisciotti Foundation. This significant investment aims to bridge the gap between academic research and industry innovation, catalyzing the development of innovative companies, groundbreaking technologies, and a thriving entrepreneurial ecosystem in Baltimore, Maryland. They provide crucial support, including capital, program management, and strategic scientific and business insights, to drive the growth of the BioHealth industry. Their team of seasoned life sciences professionals operates on a value-driven model, committed to reducing the risk of groundbreaking technology for commercialization, attracting crucial investments, nurturing start-ups, and cultivating meaningful public-private partnerships. Their vision is grounded in promoting a thriving ecosystem in Baltimore that will contribute significantly to the growth of the BioHealth sector in the region.

BETHESDA, Md., Nov. 24, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (“Gain” or the “Company”) (Nasdaq: GANX) today announced the closing of an underwritten public offering of 2,545,000 shares of its common stock and warrants to purchase up to an aggregate of 1,272,500 shares of its common stock at a combined public offering price of $2.005 per share and accompanying warrant, including 331,956 shares of common stock and warrants to purchase 165,978 shares of common stock issued pursuant to the full exercise by the underwriter of its over-allotment option. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $4.01 per set of securities, yielding an effective price of $2.00 per share and $0.01 per warrant. The warrants were sold at the rate of one warrant for every two shares of common stock. The warrants have an exercise price of $2.75 per share, are exercisable immediately, and will expire five years following the date of issuance.

Are you navigating the complex terrain of healthcare innovation? The National Institutes of Health (NIH) offers a powerful tool to guide your journey: the TABA Needs Assessment Report. This complimentary, unbiased report is a game-changer for companies in the critical Phase I of their projects.

What Does the Report Offer?

The TABA Needs Assessment Report is a comprehensive evaluation tool that scrutinizes four pivotal areas:

1. Intellectual Property and Market Entry: It assesses your project's intellectual property and potential barriers to entering the market.
2. Market Positioning: The report evaluates your project's standing in the competitive healthcare landscape.
3. Regulatory and Clinical Strategies: It reviews your plans in regulatory compliance, manufacturing, and clinical trials.
4. Business Model Analysis: The report delves into the profitability and sustainability of your business model.

LOWER GWYNEDD, Penn.--(BUSINESS WIRE)--ChromaTan, Inc., a bioprocess development company revolutionizing the 123-year-old traditional batch biopurification process through transformational next-generation biomanufacturing solutions, announced today that it has been selected as a BLUE KNIGHT™ company.

Are you ready to explore the transformative world of MedTech and its profound impact on healthcare? Join us in this episode of BioTalk with Rich Bendis as we dive deep into medical technology with an exceptional guest, Neal Piper, Founder & CEO of Luminoah, winner of the 8th Annual BioHealth Capital Region Crab Trap. Neal Piper is the visionary behind Luminoah, a cutting-edge MedTech company dedicated to enhancing the lives of enteral nutrition patients through innovative hardware and software systems. With a background steeped in healthcare, Neal's journey from Pfizer's Neuroscience Division to his role as President of the Global Health Fellows Alumni Business Network has uniquely positioned him to drive change in the industry. But what inspired Neal to create Luminoah? In 2019, his family received a cancer diagnosis for their 3-year-old son, leading to a new reality and a pressing need for a better nutritional feeding program. Neal recognized the challenges faced by patients and caregivers, from bulky equipment to limited data sharing with physicians. That's when Luminoah was born.

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