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NEWARK, Del., Sept. 29, 2022 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announces a Biomanufacturing Readiness Levels (BRLs) framework to lay the groundwork for a universal assessment of technology maturity and readiness level for commercial biomanufacturing technology adoption.

The BRL framework, described in the Biotechnology and Bioengineering journal, will benefit technology innovators, developers, and adopters with the ability to assess the maturity level of technology implementation during the clinical trials and commercial scale manufacturing processes that will allow them to overcome technology adoption hurdles from inception to commercialization. Modeled after the successful Manufacturing Readiness Levels developed by the Department of Defense, BRLs provide a tailored approach to the technology adoption journey that is specific to the biopharmaceutical industry.

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GAITHERSBURG, Maryland and VANCOUVER, British Columbia – September 29, 2022 – miRecule, Inc., an innovator of next-generation RNA therapeutics, and SOLVE FSHD, a venture-philanthropy organization catalyzing the pace of innovation to accelerate a cure for facioscapulohumeral muscular dystrophy (FSHD), today announced that SOLVE FSHD has invested US$1 million in miRecule to support the discovery of the company’s anticipated best-in-class antibody-RNA conjugate (ARC) designed to be a disease-modifying treatment for the underserved FSHD patient population.

Click here to read/download the PDF

Isabella Casillas Guzman SBA Administrator

WASHINGTON – Administrator Isabella Casillas Guzman, head of the U.S. Small Business Administration and voice for America's 33 million small businesses in President Biden's Cabinet, released the following statement today after the House voted to reauthorize funding for the Small Business Innovation Research (SBIR) program:

"Today's Congressional vote demonstrates overwhelming bipartisan support for the Small Business Innovation Research program which is vital to our nation's capacity to innovate and improve the lives of all Americans.  When President Biden signs this bill, America's innovators, scientists and entrepreneurs will have another three years of certainty as they continue to create opportunities which lead to jobs and equity in our nation's innovation economy.  If past performance of the SBIR program is any guide, new generations of entrepreneurs will be breaking barriers in science, medicine, and technology, while ensuring that the United States maintains its position as an innovation leader at the forefront of science and technology in a rapidly evolving global market.  A new three-year reauthorization for SBIR is a significant win for our nation's small businesses and the American jobs it supports."

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Some economists say yes — and predict it's going to be bad — while others say the United States will avoid one altogether. Still others forecast that one will linger for a while, but be relatively shallow.

But even if the country can't dodge what many fear will follow record levels of inflation, a panel of experts in the life sciences field said on Tuesday they're optimistic that the Frederick County biohealth sector may be spared from the worst effects of an economic downturn.

 

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Newswise — The National Institutes of Health, through its Blueprint MedTech program, has established two incubator hubs and launched a funding solicitation in support of commercially viable, clinically focused neurotechnology solutions to diagnose and treat disorders of the nervous system. Blueprint MedTech relies on the collaborative framework of the NIH Blueprint for Neuroscience Research, which includes the NIH Office of the Director and 12 NIH institutes and centers that support research on the nervous system.

 

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Vertex Pharmaceuticals will continue to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support gene-edited cell therapy exa-cel, formerly known as CTX001™ for hemoglobinopathies

ROCKVILLE, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with Vertex Pharmaceuticals Incorporated, a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

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Twenty-four week interim analysis on approximately 160 subjects planned for Q1 2023 September 28, 2022 07:30 ET | Source: Altimmune, Inc

GAITHERSBURG, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of first dosing of all subjects in its Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

MOMENTUM is a multicenter, randomized, placebo-controlled trial that is ongoing at approximately 30 sites in the United States, with Dr. Louis J. Aronne, Founder and Director of the Center for Weight Management at Weill-Cornell Medical Center, and a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator. Approximately 320 subjects with obesity or overweight and without diabetes are being randomized 1:1:1:1 to either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The primary endpoint of the trial is the relative (percent) change in body weight at 48-weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.

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The Company's Fifth Acquisition Deepens Ophthalmology Credentials and Enhances Global Reach

ROCKVILLE, Md., Sept. 28, 2022 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Clinical Edge. Clinical Edge trains and certifies visual function examiners at investigator sites conducting Phase I to IV ophthalmic clinical trials.

The combination of Optym, Emmes' ophthalmology certification unit, and Clinical Edge will make the organization a leader in ophthalmic certification and training services.

Emmes officially rolled out the new name – OptymEdge – and branding ahead of the American Academy of Ophthalmology annual meeting, which takes place in Chicago from September 30 to October 3.

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GAITHERSBURG, Md., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® (brincidofovir), the first oral antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.

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Today, President Joe Biden announced his intent to appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans.  On the 60th anniversary of President John F. Kennedy’s Moonshot speech, Dr. Wegrzyn will join President Biden today at the John F. Kennedy Presidential Library in Boston as he discusses his bold vision for another American Moonshot: ending cancer as we know it.

 

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ROCKVILLE, MARYLAND, September 26, 2022 – When it was announced that the winner of the 7th Annual BioHealth Capital Region Crab Trap would be the recipients of a larger than ever prize pool, organizers didn't expect that two companies would benefit thanks to unique circumstances. The main winner, Neuroene Therapeutics, a biotech company focused on discovering, developing, and commercializing novel therapeutics for difficult-to-treat neurological disorders, was selected from five finalists as the company with the most commercial potential at the 7th Annual Crab Trap Competition.

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Gaithersburg-based Neuroene Therapeutics and its approach to treating a rare form of epilepsy were crowned the winner of the seventh annual Crab Trap Competition, which highlights the commercialization potential of biohealth technologies throughout the BioHealth Capital Region.

The company was largely recognized for its lead asset, NT102, a Vitamin K analog demonstrating broad seizure protection in preclinical animal models. In particular, the asset showed protection against seizures in Dravet syndrome, a rare genetic disease marked by severe encephalopathy and epilepsy that doesn’t respond well to current medications.

Game changers Regional effort links academics and entrepreneurs with economic development

Startups. Capital. Entrepreneurship. These weren’t always terms in Amy White’s daily lexicon.

A trained scientist, White dedicated 15 years to teaching microbiology, focusing on the world that happens within the laboratory.

“I really never thought beyond the pipette, right,” she recalled at a recent biotech event, Game Changer Week, that was organized in Roanoke.

 

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Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.

 

Sen. Ben Cardin (D-Md.) is the chairman of the Committee on Small Business and Entrepreneurship.

The Small Business Innovation Research program is a big step further away from ending.

The Senate passed a three-year authorization of SBIR and the Small Business Technology Transfer Research program by unanimous consent on Sept. 20.

Sen. Ben Cardin (D-Md.), chairman of Committee on Small Business and Entrepreneurship, introduced and the full body passed the SBIR and STTR Extension Act of 2022 on Wednesday after several months of delay because of concerns from Sen. Rand Paul (R-Ky.) about companies abusing the program.

Image: Sen. Ben Cardin (D-Md.) is the chairman of the Committee on Small Business and Entrepreneurship. - https://federalnewsnetwork.com

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Fifth Milestone Achieved by HemoShear with Novel Compounds for Second Target

CHARLOTTESVILLE, Va., Sept. 21, 2022 /PRNewswire/ -- HemoShear Therapeutics, Inc., a privately held clinical stage biotechnology company, has earned a milestone payment for the advancement of potential lead product candidates against a second target for the treatment of gout under its collaboration with Horizon Therapeutics plc ( Nasdaq: HZNP). This milestone marks the fifth payment that HemoShear has earned in accordance with the Horizon exclusive drug discovery agreement established in January 2019.

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Doubling the University of Maryland BioPark's lab space, the two-phase 4MLK development project will represent more than $320 million in total capital investment

BALTIMORE, Sept. 22, 2022 /PRNewswire/ -- University of Maryland, Baltimore (UMB) and Wexford Science & Technology, LLC, announced today that 4MLK, the newest development project in the University of Maryland BioPark, is slated to move forward, with groundbreaking this fall (2022) and delivering in summer 2024. The 8-story, 250,000-square-foot building, Phase I of a two-phase project representing a $320 million total capital investment, will provide critical wet laboratory space in downtown Baltimore for researchers and companies, flexible lab and office/support space for start-ups, and Class A office space, along with areas for convening and a conference center.

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ROCKVILLE, Md., Sept. 21, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research, as well as next-generation cell therapeutic discovery, development and commercialization, today announced that it has relocated its headquarters to 9713 Key West Avenue in Rockville, Maryland, 20850, within Maryland’s I-270 Biotech Corridor. The Company’s new 67,000 square-foot facility significantly increases its in-house manufacturing capacity, as well as research and process development lab space. This investment represents a major milestone in MaxCyte’s growth and its ability to support customers and partners in their journey through therapeutic development to commercialization.

White House Inks Strategy to Grow Trillion Dollar[+]
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The U.S. bioeconomy is booming. Valued at nearly one trillion dollars and predicted to grow globally to over $30 trillion over the next two decades, bioproducts now include everything from the food that we eat to the vaccines we put in our arms. Plant-based burgers, recyclable bioplastics, concrete, clothing, and microbes for mining minerals are just a few of the latest bio-based products coming to market.

Image: White House Inks Strategy to Grow Trillion Dollar[+] DALL-E X JOHN CUMBERS

Cursor and UCSF scientist says Biden s cancer moonshot achievable

OAKLAND, Calif. - President Biden revived his call for a nationwide cancer moonshot effort on Monday, as he marked the 60th anniversary of President Kennedy's famous pledge to get a man on the moon.

"The goal is to cut cancer death rates by at least 50%, at least 50% in the next 25 years," said President Biden, "To turn more cancers from death sentences into chronic diseases people can live with."

Image: https://www.ktvu.com

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Startup companies have traditionally looked for the most experienced venture capitalists they could find to get their businesses off the ground and support their growth. That’s not always the case anymore, according to a study by University of Maryland Robert H. Smith School Associate Professor Rich Mathews and his co-author Naveen Khanna of Michigan State University. They argue that startups straight out of the gate are often deciding to work with new venture capitalists rather than established ones.

 

The University of Maryland Medical Center in Baltimore.

(Photo by Flickr user Baltimore Heritage, used via a Creative Commons license)

One of Maryland’s premiere medical networks just announced an eight-figure investment into the economic development of local and marginalized communities by way of notable funding entities.

The University of Maryland Medical System (UMMS) said in a Thursday statement that it will commit  $14 million to  11 community development financial institutions and privity equity firms throughout the state. The investment is intended to address racial, economic and environmental disparities in the communities the system serves.

Image: The University of Maryland Medical Center in Baltimore. (Photo by Flickr user Baltimore Heritage, used via a Creative Commons license)

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CHARLOTTESVILLE, Va., Sept. 15, 2022 /PRNewswire/ -- AMPEL BioSolutions today announced a breakthrough in precision and personalized medicine that can detect and predict the severity of COVID-19 in patients while also determining the best treatment options for each specific case. The company's new approach, through a simple blood test, will ultimately accelerate the means of providing effective treatments to the right people at the right time and potentially stem the serious illness caused by SARS-CoV-2 infection that can lead to lung damage or death.

AMPEL's new genomic test, known as CovGENE®, has been validated by a longitudinal study in partnership with physicians in the Division of Pulmonary and Critical Care Medicine of the University of Virginia Medical Center. With careful analysis of patients admitted to the UVA Intensive Care Unit, CovGENE® demonstrated remarkable precision with a greater than 90-percent rate of accuracy. CovGENE®, can be administered by drawing a patient's blood to quickly ascertain whether a Covid-19 patient will have a mild, moderate, or severe outcome. The findings are detailed in a paper published today by Frontiers in Immunology.

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Waltham, Mass. and Dublin – August 15, 2022 — Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.

ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

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La Vista, Nebraska — September 14, 2022 – Streck announced today a Series B investment in Ceres Nanosciences (Ceres). The funds from this investment will be used to accelerate the development and commercialization of both diagnostic and research use products utilizing Ceres' Nanotrap® technology platform.

"Streck has a deep presence in and knowledge of the diagnostics industry and shares our commitment to building long-term relationships with partners and customers," said Ceres CEO Ross Dunlap. "We are thrilled to have Streck's support and guidance in this next, exciting phase of our growth."

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Swimming with Sharks pairs aspiring healthcare entrepreneurs with successful innovators and investors. The startups selected will pitch at the American Society of Anesthesiologists (ASA) Annual Meeting, ANESTHESIOLOGY®, in October 2022.

There will be two Swimming with Sharks sessions at the event: one for very early-stage startups (back of the napkin ideas/conceptual/pre-seed stage) and one for startups that are seed stage and beyond (ie series A).

 

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September 13, 2022—The Maryland Stem Cell Research Commission announced it will grant $4,165,325 in award funding to innovative research that will strengthen and advance stem cell treatments and technologies in Maryland. Awardees submitted proposals to the Commission in response to its Request for Applications (RFAs) for its first round of funding cycle in fiscal year 2023.

Recipients include 12 scientists accelerating research at Johns Hopkins University, University of Maryland, Baltimore County, University of Maryland, College Park, and the University of Maryland, Baltimore. Their research addresses an array of medical conditions, such as cancer, eye, heart, bone, blood, digestive, and immune system diseases.

 

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- The Company plans to work with the FDA to design a Phase 3 program in moderate-to-high systemic disease activity patients to begin in 2023, ahead of expectations –

DUBLIN--(BUSINESS WIRE)--Sep. 12, 2022-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren's syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity as defined by the European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥ 5. At Week 24, patients treated with dazodalibep achieved a 6.3-point reduction in their ESSDAI score and patients treated with placebo achieved a 4.1-point reduction, resulting in a statistically significant least squares mean difference of 2.2 points (p=0.017).

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The Biden administration announced the launch of a new national program dedicated to fortifying America’s biotechnology manufacturing industry in the latest executive effort to keep U.S. supply chains competitive.

Introduced Sunday via executive order, the Biotechnology and Biomanufacturing Initiative focuses on a specific biomanufacturing process that uses microorganisms to create chemicals and compounds that contribute to make medicines, fuels and other input materials.

 

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As the number of monkeypox cases around the world has ballooned since early May, so too has the list of diagnostic developers rapidly churning out tests for the virus.

Latest to join the likes of Labcorp, Roche, BD, Cepheid and others in that mission is Qiagen, which announced this week the launch of a monkeypox assay of its own. The test is designed to be analyzed by the company’s QIAstat-Dx PCR testing system.

Image: The QIAstat-Dx Viral Vesicular Panel is indicated for research use only, making Qiagen’s test available to the approximately 3,000 laboratories around the world that already have QIAstat-Dx PCR analyzers installed. (Qiagen)

Alexandria® Building the Future of Life Science™

NEW YORK, Sept. 12, 2022 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. ( NYSE: ARE), the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, agtech and technology campuses in AAA innovation cluster locations, is proud to recognize and celebrate multiple significant milestones from its position of leadership in New York City's commercial life science cluster. These milestones include (1) 20 years since Alexandria Venture Investments made its first NYC venture investment in Intra-Cellular Therapies' Series A financing in 2002; (2) 17 years since Alexandria was awarded the New York City Economic Development Corporation's (NYCEDC) request for proposal (RFP) in 2005 to develop and operate what the company has transformed into the Alexandria Center® for Life Science – New York City, the city's first and only commercial life science campus; (3) 12 years since the Alexandria Center officially opened to welcome its first tenants in 2010; and (4) five years since it unveiled the inaugural site of Alexandria LaunchLabs®, the company's world-class life science startup platform, at the Alexandria Center in 2017, which was followed by Columbia University's election in 2019 to establish a second NYC-based Alexandria LaunchLabs site on the university's medical school campus.

 

CrabTrap 2022

– Winner to be announced as part 2022 BioHealth Capital Region Forum –

ROCKVILLE, MARYLAND, September 12, 2022 – A panel of investor judges and anROCKVILLE, MARYLAND, September 12, 2022 – A panel of investor judges and anaudience of industry leaders will gather for the presentations of five early-stage companiesat the 7th Annual BioHealth Capital Region Crab Trap Competition at US Pharmacopeia onSeptember 21st in Rockville, Maryland. Created in 2016, the competition highlights thecommercialization potential of biohealth technologies throughout the region and beyond.

Click here to download the PDF

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BioHealth Innovation, Inc. (BHI) has partnered with Montgomery County, Maryland to support entrepreneurs seeking to commercialize life sciences, digital health, and medical device technologies within Montgomery County.  The new BHI-County agreement will fund one or more Executives in Residence, dedicated to cultivating the local life sciences ecosystem within Montgomery County.

Background

Over a decade ago, BHI was founded in Rockville, Maryland to coordinate and amplify the county’s existing innovation assets. Since then, our work has expanded to the BioHealth Capital Region (any beyond) by connecting life sciences, biotech and healthcare stakeholders, developing entrepreneurial talent, identifying commercially relevant federal and university technology, and attracting funding for growth-stage companies.  BHI’s original goal of raising the BioHealth Capital Region’s life sciences cluster ranking to one of the “Top 3 by 2023” is within reach.