On July 25, 2024, the FDA will host a significant virtual public meeting, "Home as a Health Care Hub – Stakeholder Listening Session," from 12:00 PM to 4:00 PM ET. This session aims to explore how integrating home environments into the healthcare system can enhance health equity and patient care. The FDA seeks input from various stakeholders to identify both barriers and opportunities in this integration. Additionally, the initiative includes developing VR prototypes for managing conditions like diabetes.

Stakeholders are encouraged to register, participate, and submit comments or presentations ahead of the event.

For more information and registration details, Click here.

GERMANTOWN, Md., July 23, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the appointment of Phil Tennant as the Company's chief commercial officer. Mr. Tennant will be responsible for commercial strategy and execution across US and global markets. His initial focus will be on driving commercial readiness activities for the potential launch of the first- and best-in-class PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Mr. Tennant will report to Precigen's President and CEO, Helen Sabzevari, PhD, and will join Precigen's executive leadership team.

ROCKVILLE, Md., July 23, 2024 /PRNewswire/ -- Emmes Group, a leading specialty tech-enabled global contract research organization (CRO), today announced a multi-year strategic partnership with Miimansa AI. A critical pillar of the partnership, aimed at revolutionizing clinical research at Emmes, is the acquisition of Miimansa's Clinical Entity Modeling tools based on advanced large language modeling (LLM) techniques and generative AI.

Artificial intelligence (AI) promises to transform all aspects of healthcare including clinical research. Emmes Group is rapidly maturing its technology platform, Veridix AI, and Miimansa's Clinical Entity Modeling technology will serve as a critical building block to accelerate the development of state-of-the-art automated text processing solutions tailored for clinical research.

Maryland-based biopharmaceutical company receives funding from TEDCO’s Venture Funds'

COLUMBIA, Md., (July 23, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 investment in Solaxa Inc. This investment is from TEDCO’s Venture Funds, with $200,000 being allocated from the State Small Business Credit Initiative (SSBCI) funding.

“At Solaxa, we are developing neurorestorative treatments for children and adults suffering from rare neurodegenerative diseases and acute nerve injuries,” said Christian Walker, CEO and founder of Solaxa. “Thanks to TEDCO’s investment, we can accelerate our work to serve patients with spinocerebellar ataxias for whom our first drug has already been shown to deliver significant clinical improvement in gait, balance and speech.”

In the rapidly evolving world of life sciences, the real estate sector is experiencing significant shifts and opportunities. JLL’s latest report, U.S. Life Sciences Property Report, explores the dynamics of leasing, occupancy rates and market conditions.

To learn more about the life sciences market in Washington, D.C., we sat down with local experts, JLL Research Manager Kate Paine and Executive Managing Director Pete Briskman to delve deeper into these trends and gain valuable insights.

In the D.C. market, how have lease terms in the life sciences sector changed over time and what factors have influenced these changes?

Mirroring national leasing trends, lease terms in the D.C. market are shortening, especially among new leases and relocations. The average lease term for new leases (non-renewals) has fallen to just over five years, down from nearly 10 years in 2022. Shortening of lease term is a response to supply outpacing demand, which is giving the leverage back to tenants and allowing startups and pre-revenue tenants to negotiate for shorter terms. A key contributor to shortening lease terms over the past few years is the influx of spec suites that have delivered to the market, which are designed to be flexible space options for early-stage companies.

The National Cancer Institute's (NCI) Technology Transfer Center invites you to the 2024 Technology Showcase on September 4th, at the Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD. This free, in-person event will present a remarkable lineup of cutting-edge technologies ready for commercialization. Industry experts will share their insights through engaging presentations, panel discussions on successful collaborations, and a competitive poster session highlighting innovative research.

Attendees will have the opportunity to connect with industry leaders, investors, and entrepreneurs, fostering meaningful networking and potential partnerships. The keynote speaker, Steven Walker, will deliver a compelling address on the future of biotechnology and its impact on cancer research.

The event is an exceptional platform for biotech stakeholders to discover new technologies and explore collaborative ventures. Whether you're a company, investor, or entrepreneur, the 2024 Technology Showcase offers invaluable insights and connections.

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., speaks with Matt Gardner, Head of Life Sciences, Americas, at CBRE. With over 30 years of experience in the technology and life sciences sectors, Matt Gardner provides a comprehensive look at the latest trends and developments in the life sciences industry.

Matt shares key findings from CBRE's recently released U.S. Life Sciences Talent Trends' report for 2024, offering insights into what the life sciences sector can expect in the coming year. He discusses the national real estate market, highlighting the differences between office space and life science wet lab space, and emerging trends in the sector.

The conversation explores the strategic importance of the BioHealth Capital Region (BHCR), consistently ranked as a top market for life sciences research talent. Matt elaborates on what makes this region crucial for CBRE and the life sciences sector as a whole.

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With the advent of life-changing cell and gene therapies (CGTs) to treat pediatric diseases, price is becoming a significant obstacle to care and cures.

Successful therapies can wind up shelved or in hard-to-reach clinical trials for a litany of reasons: high manufacturing costs, significant regulatory burdens, a lack of enthusiasm from the pharmaceutical industry in the small pediatric market and the simple fact that insurance companies resist paying the price of $1 million or more for a therapeutic. When successful treatments are set aside and become victims of this market failure, leaders in pediatric medicine say the drug has been relegated to the “Valley of Death.”

Experts at Children’s National Hospital and other leading U.S. research institutions are working to ferry drugs across it.

BioMaP-Consortium Project Agreement Will Combine Sustainable Biochemical Production with AI To Demonstrate a Scalable Platform for the Quick Manufacture of Pharmaceutical Ingredients.

STERLING, Va., July 19, 2024 (GLOBE NEWSWIRE) -- Many ingredients that make up the pharmaceuticals Americans rely on are manufactured overseas. When supply chain issues or shortages occur, as witnessed during the COVID pandemic, it can negatively impact millions of Americans and affect national security. The White House issued an Executive Order in 2022 to stimulate U.S. biomanufacturing. Increasing American biomanufacturing, will provide more control over pharmaceutical production, boost the economy, and encourage creation of greener manufacturing methods.

Under a new $7.5 million, two-year project agreement awarded to Capra Biosciences through the BioMaP-Consortium, Capra will demonstrate the ability of its platform to rapidly scale and manufacture biologically derived small molecule active pharmaceutical ingredients (APIs). Capra has a demonstrated history of using its biofilm-forming microbes and proprietary bioreactors to transform low-cost feedstocks into a variety of chemicals, including their first commercial product, retinol.

Shuttle Pharma’s Selective HDAC Inhibitor Exhibits ATM Activation and Modulation of ER Expression Resulting in Substantial Growth Inhibition of Estrogen Receptor Positive Breast Cancer Cells, as Reported in PLOS ONE

GAITHERSBURG, Md., July 19, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced the publication of a manuscript reporting on the ability of one of the Company’s HDAC inhibitor pre-clinical assets, SP-1-303, which exhibits ataxia-telangiectasia mutated protein (ATM) activation and modulation of estrogen receptor expression resulting in substantial growth inhibition of estrogen receptor positive breast cancer cells (ER + BC).

In 1996, Martine Rothblatt’s six-year-old daughter was diagnosed with pulmonary arterial hypertension, a rare lung and heart disease without a cure. Undeterred, Rothblatt, a cofounder of Sirius Satellite Radio, launched her own biotech firm with the goal of finding one.

“There is nothing worse than being told that your daughter is going to die,” https://www.forbes.com/sites/chloesorvino/2018/06/20/how-ceo-martine-rothblatt-turns-moonshots-into-earthshots/" aria-label="Rothblatt told Forbes">Rothblatt told https://www.forbes.com/sites/chloesorvino/2018/06/20/how-ceo-martine-rothblatt-turns-moonshots-into-earthshots/">Forbes in 2018. “I just said I will find a way, or she was going to die, because all of the previous people with this illness had died.”

Nearly three decades later, Rothblatt’s daughter is healthy and in her 30s. Meanwhile, shares of the now publicly traded firm, United Therapeutics, are up 54 times its price at its 1999 IPO. This year alone, shares have surged, up 50% so far in 2024 and up 40% since April 30—enough to make Rothblatt the world’s newest billionaire.

By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments. Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients.

The Rare Disease Innovation Hub
Recent rapid advances in the identification of promising drug targets and development of gene therapies offer momentum and potential to meet the needs of patients with rare diseases. In 2023, over half of all the novel drugs and biologics approved by the FDA’s Center for Drug Evaluation and Research (CDER) and the FDA’s Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease or condition.

D.C.-based maternal mental health startup Seven Starling has raised $10.9 million in an oversubscribed round to expand its virtual care services — which include supporting postpartum, early parenthood, infertility, miscarriage and loss and other experiences — further across the country.

San Francisco women’s health-focused venture firm RH Capital led the round and existing investors Menlo Park, California's Pear VC; San Francisco’s Expa; Santa Monica, California’s Magnify Ventures; Palo Alto, California’s Emerson Collective; and Emeryville, California’s Inflect Health also took part.

Emerson Collective is led by Laurene Powell Jobs, who is an investor in D.C.'s Monumental Sports & Entertainment, the owner of the Washington Wizards, Capitals, Mystics and other sports ventures. Emerson counts The Atlantic magazine, which is based in the District, among its holdings.

COLUMBIA, Md., (July 16, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 investment in OmniSpeech. This investment was made in two parts, with $300,000 coming from TEDCO’s Venture Funds and the remaining $200,000 coming from TEDCO’s Social Impact Funds.

“After decades of research and development, we are excited to expand our reach to improve more apps and devices with AI/ML-powered speech,” said Carol Espy-Wilson, founder and chief technology officer at OmniSpeech. “With TEDCO’s generous investments, we are excited to advance our innovative AI and machine learning technologies.”

Foreign investors highlighted innovative and high-quality human resources as a strength of Korean biotech companies. They also recognized advantages in Korea’s active government investment and robust infrastructure for clinical trials and development. However, they also pointed out that Korea’s conservative corporate culture and limited funding needed improvement.

During the 'Bioplus-Interphex Korea 2024 (BIX 2024)' conference at COEX in Samsung District, Seoul on July 12, in a special session themed 'The charm of Korean biohealth according to foreign investors', Hwee Juin Lee, Vice President of Asia Pacific Region at Flagship Pioneering, emphasized, “Seoul is a cosmopolitan city as the premier global hub for clinical trials, hosting a diverse array of cutting-edge research centers.”

CHARLOTTESVILLE, VA – July 15, 2024 – Today AMPEL BioSolutions, with collaborators Lupus Therapeutics and Aker Biomarine, revealed peer-reviewed results that supplementation with Omega3-rich Krill Oil improves disease activity of autoimmune Lupus patients. 

Omega3 lipids called polyunsaturated fatty acids (PUFAs) that are found in microscopic shrimp-like crustaceans called Krill from the waters around Antarctica are key to maintaining a low inflammatory state.  Some studies indicate that Krill contains Omega3 in an easily digested phospholipid form that may achieve more effective integration into cellular membranes compared with the triglyceride-rich form predominant in fish oil.  And the concentrated Superba Boost Krill Oil (AKBM-3031) was highly ranked by the evidence-based CoLTs (Combined Lupus Treatment Scoring) published approach for testing in the ORKIDS clinical trial.

As we gear up for the 10th Annual BioHealth Capital Region Forum on September 17^th-18^th, 2024, at the US Pharmacopeia in Rockville, MD, we invite your organization to become a sponsor. This year’s forum marks a decade of innovation and collaboration within the biohealth sector and offers unique sponsorship opportunities that promise substantial visibility and engagement. You can become a sponsor with unique new sponsorship opportunities this year, including “Lunch Sponsor” and “Reception Sponsor” for both days.

Sponsoring the forum ensures that your organization’s logo will be prominently displayed on all event materials, daily presentation decks, and standees positioned strategically throughout the venue. This visual branding extends throughout the event, ensuring your message reaches all attendees. Furthermore, all sponsors are invited to an exclusive VIP Leadership Dinner, providing a prime networking opportunity with top industry leaders.

In this episode of BioTalk with Rich Bendis, we have the honor of speaking with the U.S. Ambassador to the Republic of Tunisia, Joey R. Hood. With an impressive diplomacy and international relations background, Ambassador Hood sheds light on the vital collaboration between the U.S. and Tunisia in scientific research, innovation, and technology transfer.

Ambassador Hood discusses the current status of U.S.-Tunisia cooperation in scientific research and technology transfer, emphasizing these areas’ critical role in Tunisia’s development. He highlights the importance of scientific research, innovation, and technology transfer in Tunisia and explains how the U.S. can support and enhance these efforts.

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RNA therapies developer miRecule is partnered with Sanofi on the development of a treatment for facioscapulohumeral muscular dystrophy, or FSHD. MiRecule, winner in the biopharma track of MedCity News’s Pitch Perfect startup competition, is now pursuing a Series A round of financing.

For biotech companies with platform technologies, one common goal is finding a big pharmaceutical partner interested in jumping onto that platform sooner or later. For miRecule, the collaboration came sooner. Within four years of its formation and still preclinical, the startup found itself working with Sanofi to develop an RNA therapy for a rare muscle disorder.

Most research-intensive universities in the US — including globally renowned institutions such as Stanford, Cornell and Yale — do not have their own venture fund to back spinouts.

Just 50 out of the 146 universities that are at the top rank of the Carnegie classification — a scale that measures the amount of doctoral research they produce — have an investment vehicle.

These universities, by and large, produce the most spinouts and typically have infrastructure, like incubators or maker labs, in place to support fledgling startups. Many of the tech transfer offices run entrepreneurs-in-residence programmes to bring in the right expertise to run spinouts.

Maryland-based company seeks to revolutionize green algae growth factors 
COLUMBIA, Md., (July 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Pre-Seed Builder Fund investment in Phycin, Inc. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Phycin, we are focused on revolutionizing growth factor production, allowing researchers to continue their efforts with an efficient and cost-effective alternative,” said Jun Wang, CEO of Phycin, Inc. “Thanks to TEDCO’s investment, we can continue our research and development and hopefully offer more affordable and efficient solutions for various industries.”

As the first of its kind in South Africa, through a partnership between Eduvos and Task and supported by Wesgro, the inaugural Bio Centrifuge Africa competition will be selecting the winners on 17 July at the exclusive live pitching event in Cape Town.

The competition was launched this year to highlight South African talent in the expanding biotech sector and serve as a bridge between the country and the USA's BioHealth Capital Region (BHCR). This groundbreaking event promises to propel visionary health-focused innovators and biomedicine students onto the global stage.

South Africa, through the Western Cape’s biotech hub, has forged a partnership with the BioHealth Capital Region in the US. As part of this collaboration, the winner of Bio Centrifuge Africa will have the opportunity to compete at the prestigious Crab Trap competition, scheduled for September 18, 2024, in Rockville, Maryland.

COLUMBIA, Md., (July 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announces the appointment of Graham Dodge as the vice president of the Innovation Connectors department. Dodge will be responsible for providing leadership and oversight to TEDCO’s Cultivate Maryland and Innovation Connectors.

The Innovation Connectors department, previously known as TEDCO’s Entrepreneur & Ecosystem Empowerment (E3) department, is responsible for driving strategic collaborations, supporting entrepreneurial innovation and defining strategies to leverage networks and resources for innovative success. The department houses influential programs intentionally created to support entrepreneurial growth, such as the Rural Business Innovation Initiative, Urban Business Innovation Initiative, Network Advisors, Prelude Pitch and more.

Are you ready to showcase your company to some of the top minds in the industry? The 9^th Annual Crab Trap competition, a highlight of the annual BioHealth Capital Region Week, is now accepting applications from emerging companies eager to demonstrate their groundbreaking solutions. Scheduled for September 18th at the US Pharmacopeia in Rockville, MD, this competition is an unmissable opportunity for startups looking to make a significant impact.

A Platform for Pioneers

The Crab Trap provides a unique platform for startups to present their innovations before a panel of esteemed judges and a live audience. This year’s competition promises exciting prizes, including cash and business services, to accelerate the winning entry’s growth and success.

Why Enter Crab Trap?

Participating in the Crab Trap competition offers numerous benefits:

• Visibility: Gain exposure to a broad audience of industry professionals, investors, and potential partners.
• Feedback: Receive valuable insights and feedback from leaders in the biohealth industry.
• Prizes: Compete for a chance to win cash and services that can catalyze your company’s growth and development.

Apply Now

RICHMOND, Va., July 8, 2024 – Activation Capital, an innovation ecosystem development organization, announced today that Chandra Briggman, president and chief executive officer of Activation Capital, will depart the organization to pursue new opportunities to build innovation ecosystems and drive economic development.  

“Chandra Briggman’s pivotal time at Activation Capital has been defined by impact, and her impressive body of work has energized our region,” said Michael Rao, chairman of the Virginia Biotechnology Research Partnership Authority Board and Virginia Commonwealth University (VCU) president. “In 2020, Chandra was recruited from Boston/Cambridge, MA, to grow the economic impact of Activation Capital. In four years, two of which were at the height of the COVID-19 pandemic, she helped reenergize the organization with a new vision and strategy. Chandra executed a bold roadmap that has since grown our regional innovation economy and strengthened Activation Capital’s sustainability model for the future.” 

Artificial intelligence is keeping the venture capital ecosystem afloat. It accounted for more than 40% of new private U.S. "unicorns" in the first half this year, and over 60% of the increase in total venture-backed valuation, per PitchBook.

The big picture: There were 13 new U.S. AI unicorns — private companies that reached valuations of over $1 billion — between Jan. 1 and June 25 of this year.

• Elon Musk's xAI on its own added $24 billion in valuation, while all AI unicorn companies combined added $116 billion in aggregate value.
• Overall U.S. unicorn value has grown by $162 billion so far this year.

Follow the money: Over the past few years, AI accounted for about 15%-17% of venture dollars invested in North America and Europe. That number increased to about 20% in 2023 and is rising even more in 2024, according to PitchBook senior emerging technology analyst Brendan Burke.

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HONG KONG and GERMANTOWN, Md. and SUZHOU, China, July 8, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced the interim results for successful completion of the second cohort of its Phase I clinical study of GalNAc-based RNAi therapeutic STP122G, targeting Factor XI as a novel form of anticoagulation agent.

ARLINGTON, Va.--(BUSINESS WIRE)--Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration and protection, today announced the availability of Shield Spiral, an extension of the Kerecis Shield silicone fish-skin combination product range.

ROCKVILLE, Md. and SUZHOU, China, July 3, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first-in-class and best-in-class therapies for hematological malignancies, announced today that on July 2, 2024, in relation to the Exclusive Option Agreement with Takeda for the third-generation BCR-ABL inhibitor olverembatinib (HQP1351), Ascentage Pharma has received the US$100 million option payment called for by the Exclusive Option Agreement.

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received more than $250 million in contract modifications from the Administration for Strategic Preparedness and Response (ASPR) at the United States Department of Health and Human Services (HHS), to deliver millions of doses of four medical countermeasures (MCMs). These contract modifications will help ensure continued supply/stockpiling of critical MCMs to address biological threats and emergencies against anthrax, smallpox and botulism.

WASHINGTON, DC — The Biden-Harris Administration, through the U.S. Department of Commerce’s Economic Development Administration (EDA), announced another funding round of approximately $504 million in implementation grants to 12 Tech Hubs to scale up the production of critical technologies, create jobs in innovative industries, strengthen U.S. economic competitiveness and national security, and accelerate the growth of industries of the future in regions across the United States.

The Tech Hubs Program is a flagship initiative of President Biden’s Administration to invest in and grow the economies in communities across the country, advancing America’s global leadership in critical technologies, and strengthening our national and economic security.

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds of approximately $130.0 million to the Company, before deducting placement agent fees and other offering expenses. The PIPE financing is expected to close on or about July 3, 2024, subject to satisfaction of customary closing conditions.

The PIPE financing included participation from both new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., Invus, Schooner Capital, Surveyor Capital (a Citadel company), Timothy A. Springer, Ph.D., a leading mutual fund manager, and other institutional investors.

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG).

Descartes-08, Cartesian’s lead product candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) directed against the B cell maturation antigen (BCMA). It is designed to be administered as an outpatient treatment without the need for lymphodepleting chemotherapy required to achieve activity with conventional CAR-T cell therapies. Descartes-08 was previously granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG.