Pre-Clinical News
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A Phase Ii Trial Of Onapristone In Combination With Fulvestrant For Patients With Er-Positive And Her2-Negative Metastatic Breast Cancer After Progression On Endocrine Therapy And Cdk 4/6 Inhibitors
Antiprogestins act as Progesterone Receptor (PgR) antagonists. Novel and promising class of drugs to overcome endocrine resistance associated with ESR1 mutations. SMILE STUDY is a multi-institutional phase II clinical trial to determine the efficacy of an antiprogestin, Onapristone +fulvestrantas second line therapy for patients with HR+/HER2- metastatic breast cancer (MBC). Hypothesis: The ...
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ARAI-2PAM Barda Procurement Award
Broomfield, Colorado, 10/3/2022. Aktiv Pharma Group (Aktiv) today announced a procurement contract award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under this contract (number 75A50122C00082), awarded under the 2004 Project ...
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FDA Emerging Technology Program
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...
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Aktiv Pharma Group Receives Grant Funding to Develop Tranexamic Acid Autoinjector
Broomfield Colorado 6/25/2022. Aktiv Pharma Group (Aktiv) announced today a grant award from the U.S. Department of Defense (DOD) Defense Health Agency (DHA) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) [1] for the continued development of a tranexamic acid (TXA) autoinjector, targeting proposed indications related to prehospital treatment of severe bleeding. ...
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POP Biotechnologies Vaccine Technology to Enter Phase III Clinical Studies as part of Eubiologics’ COVID-19 Vaccine Candidate, EuCorVac-19
POP Biotechnologies (POP BIO), a Buffalo, NY based biopharmaceutical startup, announces the approval of the plan for a phase 3 clinical study of EuCorVac-19, a COVID-19 vaccine candidate developed by South Korean partner EuBiologics (KOSDAQ: 206650, CEO, Dr. Baik YoungOk, Mr. Seukkeun Choi) from the Ministry of Food and Drug Safety in South Korea. EuCorVac-19, is a protein-based vaccine ...
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Koning Ends the Year with $2.6M Republic Raise
NORCROSS, Ga., Feb. 1, 2022 /PRNewswire/ -- Koning, a growing medical device startup company based outside Atlanta, had a successful conclusion to 2021. The company recently finished their first Republic crowdfunding campaign, exceeding capital targets, and raising over $2.6M in only 5 months. Koning's FDA breast screening trial is also underway with participating clinics in Daytona Beach, FL and ...
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Neeuro (Singapore) and epihunter (Belgium) partner to create new and innovative digital solutions for people with brain disorders
On March 15th 2015, Tim Buckinx’ son said: “Papa, you work in digital, can’t you create a light that turns on when my brain switches off?” At ten years old, he was simply fed up with the daily impact of his refractory epilepsy. That pain became a vision, and that vision became the Belgian digital therapeutics company epihunter, aimed at enabling people with a brain ...
By Epihunter NV
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Koning Begins FDA Clinical Screening Trial in Daytona Beach, Florida
DAYTONA BEACH, Fla., Nov. 1, 2021 /PRNewswire/ -- Koning begins an FDA screening trial this month for their no-compression, Isotropic, 3-dimensional breast imaging device. The company received FDA PMA approval for commercial, diagnostic use in 2017. Since then, the Koning Breast CT (KBCT) has been installed in clinics and universities in the US and globally. "This FDA screening trial is a major ...
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Corify Care Participates In the Atrial Signals Workshop 2021
Last week (23-25th September) took place the workshop Atrial Signals 2021 http://www.atrial-signals.kit.edu/ at the Karlsruhe Institute of Technology (KIT), thanks to the joint collaboration of the Institute of Biomedical Engineering (IBT) and the Städtisches Klinikum Karlsruhe. Andreu Climent, CEO of Corify Care presented Acorys, our Non-invasive Electrocardiographic Imaging device of the ...
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Atmo Biosciences awarded Australian Government grant to automate and scale-up manufacturing of ingestible gas-sensing capsule
Atmo Biosciences has been awarded an Australian Government Manufacturing Modernisation Fund (MMF) grant to support manufacturing automation and scale-up for the Atmo Gas-Sensing Capsule. The Round 2 MMF grants, part of the Government’s Modern Manufacturing Strategy, are for small-medium sized businesses to transform manufacturing and to support job growth and develop a more skilled ...
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Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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Empatica partnering with U.S. Army MRDC to deploy COVID-19 early detection wearable
BOSTON, Nov. 6, 2020 /PRNewswire/ -- Empatica has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to deploy a wearable and algorithm that enable the early and pre-symptomatic detection of COVID-19. The project's focus is on protecting the health of the general population by preventing outbreaks via early detection and alerting. Empatica's Aura algorithm gives a ...
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Empatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appear
BOSTON, June 19, 2020 /PRNewswire/ -- Digital healthcare company Empatica announces a pioneering new partnership with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to validate an early warning system for COVID-19 and other respiratory ...
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ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung
PITTSBURGH–(BUSINESS WIRE)– April 4, 2020 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent initiation of commercial development of its next generation artificial lung, which expands the Company’s focus on highly efficient gas ...
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Empatica Announces EmbracePlus: NASA Medical Quality in a Down-to-Earth Smart Watch
BOSTON, Nov. 19, 2019 /PRNewswire/ -- On November 19th, 2019, Empatica is announcing EmbracePlus, their new smart watch built in partnership with TRISH, the Translational Research Institute for Space Health. NASA's Human Research Program partners with external entities to develop new approaches that can help reduce the risk to humans on long exploration missions. One such entity is TRISH, who ...
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New device offers a mouthful of data for chronic diseases
Aidar Health, formerly known as Multisensor Diagnostics, has developed a portable hand-held device that allows patients to measure and track vital signs in a matter of seconds. Roughly the size of an iPhone, MouthLab consists of a hand unit and a mouthpiece that fits between the teeth and lips. The mouthpiece uses special sensors to gather information from breathing patterns, saliva and blood ...
By Aidar Health
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Bened Biomedical Completes $10M Series A, Set for Expansion into US Healthcare Market
Medical probiotic leader Bened Biomedical Co., Ltd., which develops and markets neuroactive probiotic products, announced a completed Series A round of fundraising, receiving more than $10 million of capital from two prominent investors, Trans-Pacific Technology Fund (TPTF) and JAFCO Asia. With strategic support from these venture capital partners, Bened expects to rapidly expand its ...
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Bened Biomedical Affiliates US Distributor, Now Bened Life
Bened Biomedical Co, LTD., the global leader in psychobiotics with clinical studies, has acquired its US distributor Oryx Biomedical, Inc., who is pioneering the translation of microbiome research into impactful biotherapeutics and is one of the earliest stage companies bringing the gut-brain axis category of probiotics to the market. Based in Taiwan and founded by Prof. Ying-Chieh Tsai, PhD, ...
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Big Data Meets Big Biology in San Diego: Some Takeaways
At the end of the 19th century, the German scientist Paul Ehrlich began to realize that certain chemicals could have highly specific effects on certain diseases. He began to write about the possibility that a drug could act like a magische kugel—magic bullet—that killed only the organism causing disease, and nothing else. Today, scientists are amassing a new arsenal of ...
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Straight Outta Wisconsin, LynxBio Wins EvoNexus Best Demo Vote
A startup team from the University of Wisconsin that moved to San Diego in January to advance their technology for optimizing treatment regimens for cancer patients won the audience vote for best pitch at the EvoNexus Spring Demo Day last week. Lynx Biosciences founder and CEO Chorom Pak said her startup has developed microfluidic technology that uses live cancer cells to determine ...
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