FREDERICK, Md., Feb. 13, 2024 /PRNewswire-PRWeb/ -- Waisman Biomanufacturing, a leading contract development and manufacturing organization (CDMO) which is strategically part of the University of Wisconsin Madison, announced today a strategic partnership with RoosterBio, Inc., a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services.

Through this collaboration, Waisman Biomanufacturing will incorporate RoosterBio's cutting-edge MSC and exosome bioprocessing products, manufacturing protocols, and analytical services into its portfolio of biologics manufacturing services, expanding Waisman Biomanufacturing's capabilities for the production of advanced therapies for clinical trials.

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking an entry-level Life Sciences Business Strategist to join our team remotely.

Contention over the Bayh-Dole march-in rights provision is in the news again. The National Institute of Standards and Technology (NIST) proposes using the process as a “back door” for drug price controls. In comments on NIST’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, the Biotechnology Innovation Organization (BIO) states that the clause cannot be used for price controls.

In January, a team of multidisciplinary doctors performed the first case in the world of using bilateral high intensity focused ultrasound (HIFU) pallidotomy on Jesus, a 22-year-old patient with dyskinetic cerebral palsy.

The procedure is part of a clinical trial led by Chima Oluigbo, M.D., pediatric neurosurgeon at Children’s National Hospital.

WASHINGTON – Today, the National Advisory Council on Innovation and Entrepreneurship (NACIE) released its “Competitiveness Through Entrepreneurship: A Strategy for U.S. Innovation” (PDF) report that includes 10 recommendations for how the U.S. Department of Commerce, the federal government, and the private sector can foster an entrepreneurship ecosystem that ensures the United States leads in critical technology innovation.

U.S. Secretary of Commerce Gina Raimondo charged NACIE – a 32-member council comprised of leading entrepreneurs, innovators, investors, academics, and economic development leaders – with developing the report and recommendations with the aim of ensuring America’s continued global leadership in developing, commercializing, and scaling advanced technologies.

“America is the most competitive it’s ever been because we are home to the greatest innovators. But to maintain that position of power in the world, we need to keep making smart investments that will keep us ahead of the curve. That’s why the Biden-Harris Administration is laser-focused on building, strengthening, and investing in American technological innovation at every level of the economy and in every community,” said U.S. Secretary of Commerce Gina Raimondo. “NACIE’s report and recommendations provide a roadmap to help ensure America remains a global leader by expanding research and development, increasing access to capital, and fueling inclusive business growth across the country.”

ROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ --  I-Mab (the "Company") (NASDAQ: IMAB), a global biotech company exclusively focused on bringing highly differentiated immunotherapies and biologics for cancer treatment to patients around the world, today announced that as part of its strategy to become a U.S.-based biotech, its Chinese subsidiaries have entered into definitive agreements with I-Mab Biopharma (Hangzhou) Co., Ltd. (the "Hangzhou Company"), an unconsolidated affiliate of the Company, and a group of China-based investors to divest the Company's assets and business operations in China.

BioHealth Innovation (BHI) deeply mourns the loss of Dr. William G. Hearl, a former BHI Board member and a prominent contributor to the BioHealth Capital Region. Rich Bendis, BHI's President and CEO, shared, "Bill's unwavering commitment and leadership in our region have been instrumental to its growth. His dedication to fostering innovation and supporting emerging entrepreneurs and the biotech community was truly remarkable. We have lost not just a great leader but a friend who inspired many." Our heartfelt condolences go out to his family, friends, and colleagues at Immunomic Therapeutics. To read more about Dr. Hearl's legacy, visit https://www.immunomix.com/in-loving-memory-dr-william-g-hearl-immunomic-therapeutics-founder/

Germantown, MD, USA (February 07, 2024) – Amarex Clinical Research, LLC, an NSF company, announces December 2023 marked its 25th year advancing patient access to safe and effective clinical products through delivery of outstanding regulatory and clinical trial services to Sponsors within the life sciences industry.

Amarex was founded in 1998 by scientists from diverse backgrounds in academia, industry, and the FDA. Born from a vision of wanting better services from CRO vendors by correcting the many inefficiencies and deficiencies in the management and conduct of clinical trials, our founders revisited the clinical trial process and developed improved, cost-effective methods for clinical product development without sacrificing quality. Amarex’s unmatched value to Sponsors continues to differentiate Amarex from the competition by assigning senior level staff to every project, optimizing time and cost with efficient and effective processes and procedures, building true collaborative partnerships with Sponsors, and through a commitment to long-term client relationships in order to achieve successful clinical development program outcomes.

Join Children’s National Hospital for a pivotal symposium on the journey of AGAMREE® from academic research to market approval for DMD treatment in children. This event highlights the critical role of academic entrepreneurship and collaboration with industry in advancing treatments for rare diseases. Featuring insights from experts on the Vamorolone drug development program, regulatory pathways, and the venture philanthropy business model, this symposium is for those committed to making a difference in the biotech and healthcare sectors. Don't miss this opportunity to engage, learn, and network with leaders in the field.

By Sara Gilgore – Staff Reporter, Washington Business Journal - AstraZeneca PLC (NYSE: AZN) is leaving no doubt about its commitment to Montgomery County, pouring $300 million into a new U.S. manufacturing hub it’s establishing in Rockville just a couple months after taking over another building nearby.

The British pharmaceutical giant said Tuesday the facility at 9950 Medical Center Drive will start out as a space to make T-cell therapies for clinical trials in cancer, and could support other disease areas and commercial work going forward. The company also said it expects to create more than 150 new jobs at the site.

GAITHERSBURG, Md., Feb. 06, 2024 (GLOBE NEWSWIRE) -- NexImmune, Inc. a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, today announced the closing of its previously announced registered direct offering of 304,731 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $12.05 per share (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company also issued unregistered warrants to purchase up to an aggregate of 304,731 shares of its common stock at an exercise price of $12.05 per share. The warrants are exercisable immediately and have a term of two years from the date of issuance.

Biosim AI, founded by a professor at the University of Maryland in College Park, has closed on $12.25 million in its bid to commercialize technology to “enable and accelerate drug discovery at quantum accuracy.” So far, the company has raised $13 million, with investors including Armenia’s SmartGate VC, according to Crunchbase.

Armenian-born Garegin Papoian, Monroe Martin Professor at UMD’s Chemistry & Biochemistry and Institute for Physical Science and Technology, founded Biosim AI in 2020, raising a small pre-seed investment from his home country firm, SmartGate VC.

By Alex Philippidis -February 5, 2024 - Novo Holdings, the asset manager of the foundation that controls Novo Nordisk, has agreed to acquire contract development and manufacturing organization (CDMO) Catalent for $16.5 billion—with the buyer standing to recoup two-thirds of that expense by selling three of Catalent’s fill-finish sites to Novo Nordisk for $11 billion upfront so it can meet booming demand for its blockbuster obesity drugs Wegovy^® and diabetes drug Ozempic^®, the companies said today.

The three sites—consisting of facilities in Bloomington, IN; Brussels, Belgium; and Anagni, Italy—employ more than 3,000 people combined, about one sixth of Catalent’s total global workforce of more than 18,000 people, including 3,000 scientists and technicians.

J.P. Morgan has released its 2024 Innovation Economy Outlook, offering valuable insights for those interested in the future of venture capital, investment trends, and the landscape of startup exits. This report provides an in-depth analysis of the venture fundraising environment and the challenges and opportunities that lie ahead.

The outlook delves into key areas such as the interplay between public markets and venture capital, the direction of venture capital flow, and how valuation trends are shaping the industry. It also addresses the challenges business leaders face in this evolving market and evaluates the state of the exit environment, posing the question of whether it will facilitate a rejuvenated venture capital cycle.

ROCKVILLE, MARYLAND, February 5, 2024 – BioHealth Innovation, Inc. (BHI), a leading public-private nonprofit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, proudly announces the appointment of Yaminah Leggett-Wells to its esteemed Board of Directors.

Yaminah Leggett-Wells serves as the Senior Director of Alliance Management at Amgen, overseeing global partnerships spanning all stages of drug development. With over 20 years of experience in the pharmaceutical industry, her expertise includes strategic leadership, clinical operations, business development, and project and alliance management.

Yaminah Leggett-Wells’ appointment to the BHI Board of Directors is a significant addition who brings valuable skills and experience to our organization,” remarked Richard Bendis, President and CEO of BHI. “Her extensive pharmaceutical industry background and commitment to our region make her an outstanding asset to our Board and our mission in the BioHealth Capital Region.”

Yaminah joined Amgen in 2023 following Amgen’s acquisition of Horizon Therapeutics. Prior to this, she played instrumental roles in the development of medicines for asthma and neuromyelitis optica spectrum disorder at AstraZeneca and Viela Bio, demonstrating her in-depth knowledge of drug development and regulatory affairs.

GAITHERSBURG, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, announced today the closing of an underwritten public offering of an aggregate of 1,507,139 shares of common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) and accompanying warrants to purchase 1,507,139 shares of common stock at a public offering price of $3.782 per share (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $5,700,000, prior to deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase an additional 226,071 shares of common stock (and/or Pre-Funded Warrants in lieu thereof) and/or warrants to purchase 226,071 shares of common stock to cover over-allotments at the public offering price, less the underwriting discount.

On January 31, the House passed legislation to restore the immediate expensing of R&D expenses. The Biotechnology Innovation Organization (BIO) has long advocated for this change.

Until 2022, research and development expenses were 100% tax deductible each year. However, the Tax Cuts and Jobs Act of 2017 required companies to amortize domestic expenditures over five years, and international expenditures over 15 years.

The $78 billion Tax Relief for American Families and Workers Act, passed yesterday, would reverse the change and reinstate R&D expensing. R&D expenses would be 100% deductible through 2025.

Global study will assess the safety and efficacy of the company's lead spinal fusion product, OsteoAdapt SP

FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.

With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain.

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The Maryland Department of Commerce invites companies to seize the opportunity to join the Maryland delegation at the BIO International Convention in San Diego, CA, this June 3-6, 2024. This event offers unparalleled networking, learning, and visibility for companies in the biotech sector.

Benefit from a complimentary Premier Access pass, which includes access to key partnering sessions, exhibitor booths, educational content, and exclusive networking receptions. Your company will also gain promotional exposure as part of the delegation.

To be eligible, companies must be registered and in good standing in Maryland. Selected companies are expected to actively participate in pre-conference and event activities, and share insights post-event.

Applications are due by February 21, 2024. Click here to apply now. For queries, contact This email address is being protected from spambots. You need JavaScript enabled to view it.. This is a valuable opportunity to showcase your company on a global stage. Apply now to join the Maryland delegation at BIO 2024.

February 1, 2024 Emily Wishingrad - The life sciences real estate train, which just a few years ago was reaching top speeds, is now pressing down firmly on the brakes.  

The D.C.-Baltimore region is one of the largest life sciences clusters in the U.S., and like its peers, it’s dealing with a slowdown. Biotech companies that were previously growing rapidly were hit last year by rising interest rates, slowing venture capital funding and the collapse of industry backer Silicon Valley Bank, leading to a dramatic pullback in their real estate demand. 

But the D.C. region has an advantage over other top markets during this slowdown, experts say: Developers pursued far less speculative construction during the pandemic-era demand boom. This helped the region maintain the lowest vacancy rate of all U.S. life sciences hubs, according to CBRE, but it has left developers with shovel-ready sites waiting for large tenants that have become few and far between.

“We’re a very healthy market in comparison to other regions, because we did not overbuild,” JLL Executive Managing Director Pete Briskman told Bisnow. “Other top clusters are overbuilt and don't have enough demand to fill their space. We're not overbuilt.” 

ROCKVILLE, Md., Feb. 1, 2024 /PRNewswire/ -- MaximBio, a leading innovator in next-generation healthcare diagnostic technologies, is pleased to announce that it has been granted a second follow-on award from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx^®) Tech program for the continued development of its revolutionary FiarFly™ reader and COVID-19 & Flu A/B multiplex test. This additional Phase 2 award, totaling approximately $4.4 million, will be used to accelerate the development of the FiarFly™ reader and COVID-19 & Flu A/B multiplex test and quickly prepare for clinical trials targeting this influenza season.

BALTIMORE--(BUSINESS WIRE)--Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

BALTIMORE, Jan. 31, 2024 /PRNewswire/ -- LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has entered into a definitive agreement with Boyang Trading Co., Ltd. to exclusively develop and commercialize the Lumina™ dermal filler in mainland China, Hong Kong, Macau, and Taiwan.

Lumina is the first product from LifeSprout's proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

ROCKVILLE, Md. and ST. LOUIS, Jan. 30, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue.

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.^[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.^[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.²

By Jelena Ivanjac | January 30, 2024 - The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

Application deadline is Feb. 15 for the pandemic network edition of “Make Your Medical Device Pitch for Kids!™

WASHINGTON, Jan. 29, 2024 (GLOBE NEWSWIRE) -- The Alliance for Pediatric Device Innovation (APDI) and Pediatric Pandemic Network (PPN) have teamed up to provide a unique opportunity for innovators of pediatric medical devices, diagnostics and digital health solutions. The organizations are inviting submissions for a pitch competition that emphasizes the development of medical countermeasures (MCMs) – innovations designed to address the unique healthcare needs of children during pandemics and other disasters. MCMs play a pivotal role in bolstering readiness and response capabilities to disasters arising from a broad spectrum of threats.

Johns Hopkins University has launched an ambitious endeavor that the school’s leaders say will make Baltimore a hub of the booming artificial intelligence industry.

The new Data Science and Translation Institute, announced several months ago and planned for the western edge of the Homewood Campus, is expected to be “the leading academic hub for data science and artificial intelligence – a resource that will bring world-class experts to the Baltimore region and drive game-changing innovations,” said Rama Chellappa, interim co-director of the planned institute and a Bloomberg Distinguished Professor at the school.

ROCKVILLE, Md., Jan. 29, 2024 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial.

"This is an important milestone for the company and patients suffering from rheumatoid arthritis" states Gary Fanger President and Chief Executive Officer of Rise Therapeutics. "This achievement reinforces our commitment to deliver innovative new medicines to the clinical community."

Germantown, Maryland, and State College, Pennsylvania, Jan. 25, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a first-in-kind collaboration with Penn State University in the United States to create a shared research and education facility for the fast-developing microbiome sciences.

The university-industry partnership will serve as a beacon for this field by investigating research opportunities that address challenges and research gaps facing the microbiome, which involves the research into a community of microorganisms that can be found living together in any given environment, including the human body.

Florence, Jan. 26, 2024 – PQE Group, the renowned Life Science consulting powerhouse, concludes the fiscal year 2023 with a 10% growth and an upwardly revised income exceeding 100 million euros in revenues. The Italian headquartered global firm, celebrated as a preferred advisor to pharma manufacturing and medical device corporations and SMEs globally, marks this success as a testament to its resilience, adaptability, and strategic vision amid the complex global landscape.

"At a time when many companies grapple with geopolitical challenges, crises, and inflation rates, PQE Group stands out not only for its resilience but for its ability to thrive in uncertain times, showcasing positive growth across all financial indicators," stated Gilda D'Incerti, CEO & Founder of PQE Group. "This success is rooted in meticulous planning, strategic investments in cutting-edge technologies, and a corporate culture that values agility and innovation."