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December 12, 2023

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BioTalk Podcast - Pioneering Solutions: Dr. Nehal Mehta's Quest to Combat Chronic Diseases at Mobius Scientific
 

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.

 

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Matan Companies Signs 198,000 SF Full-Building Lease with AstraZeneca in BioHealth Capital Region
 

 

Matan Companies, a leading real estate development and investment firm, announced today the successful execution of a full-building lease agreement with AstraZeneca, a global, science-led biopharmaceutical company, for 198,000 square feet at 700 Progress Way in Gaithersburg, Maryland.

This significant lease transaction further strengthens Matan Companies’ commitment to providing high-quality, cutting-edge facilities for innovative organizations in the life sciences and industrial sectors.

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University of Maryland, Baltimore Startup GlycoMantra Awarded $3.7 Million Small Business Innovation Research Phase II Grant
 

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.

 

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University of Maryland and BioGenCell Announce the Launch of BioGenCell Fifth Chronic Limb-Threatening Ischemia Clinical Trial Site in the United States
 

 

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.

 

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ARPA-H Selects Site for Stakeholder & Operations Hub
 

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.

 

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Washington's Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis
 

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.

 

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Innovent Biologics and Synaffix Expand ADC Collaboration Following Positive Preliminary Clinical Signal from Ongoing Phase 1 Study
 

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.

 

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Danaher Completes Acquisition of Abcam
 

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.

 

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United Therapeutics Named by Newsweek as One of America’s Most Responsible Companies 2024
 

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--()--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.

America’s Most Responsible Companies were selected based on publicly available key performance indicators derived from Corporate Social Responsibility Reports and Sustainability Reports, as well as an independent survey asking U.S. residents about their perception of company activities related to corporate social responsibility. The key performance indicators focused on company performance in the environmental, social, and corporate governance areas, while the independent survey asked U.S. citizens about their perception of company activities related to corporate social responsibility.

 

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Gaithersburg's Altimmune open to partnerships, deals with drugmakers, says CEO
 

By  and  - 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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FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
 
For Immediate Release: 

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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CBS19 - UVA to break ground on new biotechnology institute
 

ALBEMARLE COUNTY, Va. (CBS19 NEWS) -- State and local officials will be on hand for a groundbreaking ceremony at the University of Virginia on Friday.

UVA will be breaking ground on the Paul and Diane Manning Institute of Biotechnology.

According to a release, this institute will propel UVA to the forefront of cutting-edge medical research, fast-track the development of new treatments and cures, and transform the delivery of health care.

 

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Industry Leader and Globally Recognized Patient Advocate John F. Crowley Appointed to Lead BIO as President & CEO
 

Biotech entrepreneur, company founder, tireless patient advocate, and U.S. Navy combat veteran will guide the life science industry in its mission to feed, fuel and heal the world

December 5, 2023

The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. He will replace Rachel King, a longtime BIO board member and industry trailblazer who has served as BIO’s CEO on an interim basis for the past year.

Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. The Crowley family journey was depicted in the major motion picture “Extraordinary Measures” starring Harrison Ford, Brendan Fraser, and Keri Russell. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman. He will remain in that role until he transitions to BIO.

 

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