Drug Analysis 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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Mojo Vision Reaches Significant Development Milestone for Smart Contact Lens
New prototype of Mojo Lens incorporates numerous industry-first features, including the world’s smallest and densest dynamic display, low-latency communication, and an eye-controlled user interface SARATOGA, Calif.--(March 30, 2022)--Mojo Vision, the Invisible Computing Company, today announced its most advanced prototype of Mojo Lens, the world's first true smart contact lens, including ...
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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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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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Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity
Introduction Anliprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive and later evaluated in phase II studies for metastatic breast cancer. Because of liver enzyme elevations ...
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PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear
Champaign, Ill. – Jan. 6, 2020 – PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing healthcare providers with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi™ Scope [OtoSight Middle Ear Scope] for non-invasive imaging of the middle ear. Using optical coherence ...
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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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Zeneo® Midazolam Earns The Orphan Drug Designation
The American Food and Drug Administration (FDA) has granted Orphan Drug Designation to ZENEO® Midazolam for the treatment of status epilepticus (epileptic seizure lasting longer than 5 minutes). The orphan designation for ZENEO® Midazolam improves Crossject’s international visibility and gives impetus to its current negotiations for partnerships with pharmaceutical laboratories. ...
By Crossject
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Protheragen-ING Joins the DCAT Association
In exciting news, Protheragen-ING officially become a member of the Drug, Chemical & Associated Technologies (DCAT) Association. This move marks a significant milestone for Protheragen-ING and highlights the company's commitment to collaboration, innovation, and growth within the global pharmaceutical community. By joining forces with DCAT, Protheragen-ING, a supplier of Vitamin C Products, ...
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Alfa Chemistry Rolls Out Various Nucleic Acid Delivery Options for Nucleotide Vaccine Research
Known as a trust-worthy provider of various biochemicals and materials, Alfa Chemistry has recently announced the release of various nucleic acid delivery options for nucleotide vaccine research. These options cater to a wide range of needs in the field of vaccine development, offering researchers the necessary tools to explore new avenues in vaccine technology. Components in lipid-based delivery ...
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Revolutionize Your Drug Preformulation Workflows with the Precellys Evolution Homogenizer!
In a recent study in the European Journal of Pharmaceutics and Biopharmaceutics, Jochem Alsenz and Elisabeth Haenel present Precellys® Evolution homogenizer with Cryolys Evolution, a patent cooling system, as a versatile tool for improving preformulation processes in drug development. The study highlights the various uses of Precellys® Evolution homogenizer with Cryolys Evolution, ...
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CD Formulation Enables Efficacy Evaluation of Oral Thin Films: Ensuring Therapeutic Efficacy and Safety
A breakthrough in CD formulation has enabled researchers to evaluate the efficacy of oral thin films, ensuring both therapeutic efficacy and safety. This new development has the potential to revolutionize the way oral medications are tested and administered, leading to more precise and effective treatments for a wide range of medical conditions. The development of oral thin films has gained ...
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CD Bioparticles Introduces New Polyolefin Family Polymers for Drug Delivery Applications
CD Bioparticles, a leading manufacturer and supplier of numerous drug delivery products and services, has recently expanded its low PDI polymer portfolio and announces its new offering of Polyolefin Family polymers with a wide range of properties that make them well-suited for a variety of drug delivery applications. Low dispersion index polymers are polymeric compounds with low molecular weight ...
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CD Formulation Unveils Hydrogel Microneedle Patch Technology to Increase Drug Loading Capacity
CD Formulation, a leading pharmaceutical contract service company, has recently unveiled groundbreaking hydrogel microneedle patch technology aiming at increase the drug loading capacity and enhance drug delivery efficiency. The new technology represents a significant advancement in the field of transdermal drug delivery. The hydrogel microneedle patch consists of a patch with tiny microneedles ...
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Biopharma Stock News Bite - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) Spikes on News Potential Treatment for Alcohol Use Disorder
Investorideas.com (www.investorideas.com) Biotech Stock News Bites - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders made the NASDAQ Top ten percentage gainers today on news. The stock is trading at $2.0050, up $0.8750, gaining +77.0925% on volume of over 8o ...
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Biotech Stock News Bite - Longeveron Inc. (NASDAQ: LGVN) Stock Soars on Clinical Pipeline and 2024 Key Priorities and Goals
Investorideas.com (www.investorideas.com) Biotech Stock News Bites - Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines is one of NASDAQ's top gainers today and the stock is trending on Yahoo Finance, currently trading at $3.8955, up $1.6955 or 77.0682%. The stock had a morning high of $5.47 on volume of over 36 Million/. The Company's CEO, ...
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Synaptive Medical Receives FDA 510(k) Clearance for Near-Infrared Fluorescence Visualization, Expanding Application of Existing Robotic Exoscope
Near-Infrared fluorescence now available on Modus X robotic exoscope, complementing system’s existing advanced fluorescence capabilities New Infrared fluorescence enables the use of Modus X for visualization of vessels in conjunction with indocyanine green New patented 4K ICG Image Fusion for real-time contrast of microsurgical vessels against background anatomy Synaptive Medical ...
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