|
SAN DIEGO--(BUSINESS WIRE)-- #5hmC--ClearNote Health receives United Kingdom Conformity Assessed markings for its Avantect Multi-Cancer Detection Test and Avantect Ovarian Cancer Test
BERLIN--(BUSINESS WIRE)--Adva Network Security today announced that its FSP 3000 S-Flex™ 400Gbit/s solution has achieved a world first with approval from the German Federal Office for Information Security (BSI) for the transportation of data classified as Verschlusssache – Nur für den Dienstgebrauch (VS-NfD) – “For Official Use Only” – and EU/NATO “Restricted.” No other 400Gbit/s solution on the market has earned this level of accreditation. Leveraging Adva Network Security’s ConnectGuard™ tech
FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (“KalVista”) (NASDAQ: KALV), announced today the pricing of its offering of $125.0 million aggregate principal amount of 3.250% Convertible Senior Notes due 2031 (the “notes”) in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was in
BOSTON--(BUSINESS WIRE)--PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the pricing of an underwritten offering of 31,250,000 shares of its common stock at a price to the public of $3.20 per share. The aggregate gross proceeds to PepGen from this offering are expected to be $100 million, before deducting un
WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that Dr. Park, an emerging viral vector contract development and manufacturing organization (CDMO) based in South Korea, has selected Thermo Fisher to provide advanced bioreactors and consumables for its newest facility. Dr. Park specializes in Adeno-associated virus-based (AAV-based) viral vector production and currently at 5,000 L per batch, producing up to 40 clinical-grade ba
ATLANTA--(BUSINESS WIRE)--Mirion Technologies, Inc. (“Mirion”) (NYSE: MIR), today announced its intent to offer $250.0 million aggregate principal amount of Convertible Senior Notes due 2031 (the “notes”) in a private placement (the “convertible notes offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Mirion also intends to grant the initial purchasers of the notes an option to
HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that the Compensation Committee of the Company’s Board of Directors granted two new employees options to purchase a total of 9,750 shares of the Company’s common stock at an exercise price per share of $12.39, which was the closing price on September 23, 2025, and
MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced the grant of inducement awards of options to purchase a collective total of up to 65,750 shares of common stock. Awards were made to eight new employees of the Company. The awards were granted as an inducement material to the new employees becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and have been approved by the Company’s Compensation Committ
WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY--Incyte Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
BOSTON--(BUSINESS WIRE)--PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that it has commenced an underwritten public offering of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares and pre-funded warrants are being
BOSTON--(BUSINESS WIRE)--PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, announced positive clinical data today from the 15 mg/kg dose cohort of its ongoing FREEDOM-DM1 Phase 1 single ascending dose (SAD) study in patients with myotonic dystrophy type 1 (DM1). These latest results demonstrated a mean splicing correction of
PRINCETON, N.J.--(BUSINESS WIRE)--Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today announced the US launch of its generic iron sucrose injection following recent approval by the US Food and Drug Administration (FDA)1. The product is now available for order and delivery across the United States. The launch of this iron sucrose formulation further expands the Sandoz US iron therapy portfolio. Intravenous iron sucrose is a cornerstone therapy for iron deficiency an
LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (NYSE: OWLT) has released the following notice: IN THE UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA IN RE OWLET, INC. SHAREHOLDER DERIVATIVE LITIGATION Lead Case No. 2:24-cv-07258-FLA-PVC This Document Relates to: ALL ACTIONS. NOTICE OF PROPOSED DERIVATIVE SETTLEMENT NOTICE OF PROPOSED SETTLEMENT OF STOCKHOLDER DERIVATIVE MATTERS, HEARING THEREON, AND RIGHT TO APPEAR TO: ALL CURRENT RECORD HOLDERS AND BENEFICIAL OWNERS OF COMMON
FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (“KalVista”) (NASDAQ: KALV) announced today that it intends to offer, subject to market conditions and other factors, $110.0 million aggregate principal amount of Convertible Senior Notes due 2031 (the “notes”) in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). KalVista also inte
CHICAGO--(BUSINESS WIRE)--The Board of Directors of GE HealthCare Technologies Inc. (Nasdaq: GEHC) today declared a cash dividend of $0.035 per share of Common Stock for the third quarter of 2025 payable on November 14, 2025 to all shareholders of record as of October 24, 2025. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled
AUSTIN, Texas--(BUSINESS WIRE)--Faeth Therapeutics, a clinical-stage biotechnology company developing therapies that target tumor metabolism, today announced that results from the investigator-initiated Phase 2 DICE trial (NCT03648489) will be presented as a late-breaking oral session at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin. Title: Mini Oral session: Gynaecological cancers Location: Cologne Auditorium - CityCube A Date: Sunday, October 19, 2025 Time: 11:01 am
HOLLY SPRINGS, N.C.--(BUSINESS WIRE)--FUJIFILM Biotechnologies today celebrated the grand opening of its manufacturing site in Holly Springs, North Carolina. The newest addition to FUJIFILM Biotechnologies’ global network represents one of the largest commercial-scale cell culture biomanufacturing sites in North America. The first phase of the planned $3.2 billion manufacturing site opens with a capacity of 8 x 20,000 liters (L) mammalian cell culture bioreactors to encompass drug product and d
LEMONT, Ill.--(BUSINESS WIRE)--Argonne convenes 180+ local and regional educators and administrators to accelerate AI in STEM learning
MEMPHIS, Tenn.--(BUSINESS WIRE)--Zeta Phi Beta Sorority, Incorporated, announced today its newest and largest philanthropic commitment to St. Jude Children’s Research Hospital®. The sorority has pledged to raise $750,000 through 2028 to support groundbreaking initiatives in pediatric healthcare and research. This announcement comes during Sickle Cell Awareness Month, a time when both organizations actively advocate for increased education, support, and visibility around sickle cell disease. The
LOMA LINDA, Calif. & LITTLETON, Mass.--(BUSINESS WIRE)-- #MevionFIT--Loma Linda University Health (LLUH), the institution that created the world's first hospital-based Proton Therapy Treatment Center in 1990, and Mevion Medical Systems, the leading provider of compact proton therapy solutions, today announced a historic partnership to install the MEVION S250-FIT Proton Therapy System™. This milestone represents both a clinical leap forward and a symbolic return to the front lines of innovation for LLUH, lau
SALT LAKE CITY--(BUSINESS WIRE)-- #ARPAH--Seek Labs, a biotech company boldly seeking a healthier world through AI-powered discovery, programmable therapeutics, and point-of-care diagnostics, announced today that it has joined two federally supported innovation networks: the Investor Catalyst Hub, a regional hub of ARPANET-H launched by the Advanced Research Projects Agency for Health (ARPA-H), and the Rapid Response Partnership Vehicle (RRPV), which supports the Biomedical Advanced Research and Develop
DENVER--(BUSINESS WIRE)-- #AI--Cleerly, a leader in AI-based cardiovascular imaging, today announced that Cigna will begin covering Cleerly LABS Advanced Plaque Analysis effective October 1, 2025. The coverage decision makes Cigna the latest major insurer to recognize the clinical and economic value of Artificial Intelligence Enabled CT Based Quantitative Coronary Tomography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) technology for cardiovascular care. With more than 16 million covered lives, Cigna j
DUBLIN--(BUSINESS WIRE)--The "United States Next Generation Sequencing Market - Applications & Forecast 2025-2033" report has been added to ResearchAndMarkets.com's offering. United States Next Generation Sequencing Market is expected to reach US$ 16.57 billion by 2033 from US$ 3.88 billion in 2024, with a CAGR of 17.5% from 2025-2033. Some of the main reasons propelling the market include the growing demand for tailored medications from the general public, the growing use of products in en
STAMFORD, Conn.--(BUSINESS WIRE)---- $III #AgenticAI--Healthcare and life sciences enterprises are using generative AI, agentic AI and analytics to transform patient care and drug development, ISG says.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)---- $VYCT #ASTRO25--Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, announced today that the first prospective validation data for a molecular signature to predict hormone therapy benefit in men with recurrent prostate cancer will be presented at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology. The findings were derived using Veracyte’s Decipher GRID (Genomic Resource for Intelligent Discovery) research tool. The stud
DUBLIN--(BUSINESS WIRE)--ICON plc Schedules Third Quarter 2025 Earnings Conference Call
DALLAS--(BUSINESS WIRE)--Susan G. Komen®, the world’s leading breast cancer organization, today announced the launch of the 2025 Shop for the Cure program. This year’s program includes a variety of products and services from partners who are committed to helping fund research, patient care services and educational resources to support the breast cancer community. Every October, during National Breast Cancer Awareness Month, Komen showcases partner products and services that help make a tangible
TAMPA, Fla.--(BUSINESS WIRE)--Smart Meter, the leader in cellular-enabled remote patient monitoring (RPM), today launched iAmbientHealth™, a revolutionary ambient sensor that transforms how healthcare providers monitor patients. Unlike traditional wearables or camera-based systems, iAmbientHealth uses advanced radar technology to passively track vital signs—such as heart rate, respiration, movement, and bed exits—without requiring any patient interaction. Designed to overcome the biggest barrie
CHARLOTTE, N.C.--(BUSINESS WIRE)--Hornets Sports & Entertainment (HSE) today announced a long-term multi-year partnership with Judi Health, one of the fastest growing health technology companies in the country, as the Exclusive Jersey Patch Partner of the Charlotte Hornets. To tip off this high-impact partnership, executives from both organizations convened at the iconic New York Stock Exchange – symbolizing their shared drive for innovation, growth and excellence. “We are thrilled to welco
DALLAS--(BUSINESS WIRE)--Dwight Erskine joins the tech-enabled health engagement company to lead the next stage of growth.
PHILADELPHIA--(BUSINESS WIRE)--Aro Biotherapeutics, a clinical-stage biotechnology company developing potent and tissue-targeted short-interfering RNA (siRNA) medicines, today announced that it has completed enrollment in its ongoing Phase 1b clinical trial of ABX1100, a novel investigational therapy for the treatment of late-onset Pompe disease (LOPD). The trial is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of ABX1100 in patients with LOPD who are currently receivi
PALO ALTO, Calif. & SECAUCUS, N.J.--(BUSINESS WIRE)---- $GH--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a broad strategic collaboration to make Guardant’s Shield™ blood-based screening test available to physicians and patients served by Quest in the United States. Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal c
SAN JOSE, Calif. & LA VISTA, Neb.--(BUSINESS WIRE)-- #biotechnology--Accellix™, a pioneer in automated flow cytometry, and Streck, a recognized leader in quality control materials for flow cytometry, hematology and molecular diagnostics, have announced a strategic collaboration with the addition of the Accellix Automated Cell Phenotyping Platform to Streck’s CD-Chex Plus® (RUO) control. The Accellix platform is a compact, fully automated flow cytometer designed for point-of-need environments. It uses single-use
ATLANTA--(BUSINESS WIRE)-- #KnowFH--The Family Heart Foundation aims to improve universal screening for underdiagnosed genetic condition in children which causes early heart disease.
BELLINGHAM, Wash.--(BUSINESS WIRE)--John Connor Named Chief Business Development Officer for MCUSA Consulting
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS). The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate. Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer at Harmony Biosciences said, “Although the study did n
DURHAM, N.C.--(BUSINESS WIRE)-- #ClinicalResearch--TruTechnologies announced Mirador Therapeutics executive Jordan Zwick joined its Board of Directors.
SAN DIEGO--(BUSINESS WIRE)--Epirium Bio Inc. (Epirium), a clinical-stage biopharmaceutical company advancing medicines for neuromuscular and fibrotic diseases, today announced positive results from its Phase 1 trial evaluating MF-300, a novel therapy in development for sarcopenia. The primary endpoint of safety was achieved, and all doses of MF-300 studied were generally well tolerated with no subject discontinuations. MF-300 produced dose-related pharmacodynamic (PD) responses which were obser
PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv BioSciences, LLC today announced the commercial launch of PEXEGRA®, a biosimilar referencing Neulasta®, and FILRA®, a biosimilar referencing Neupogen®, in the Canadian market. Both biosimilars will be marketed in Canada through an exclusive agreement with JAMP Pharma Corporation. PEXEGRA® (6 mg/0.6 mL pre-filled syringe) and FILRA® (300 mcg/0.5 mL and 480 mcg/0.8 mL pre-filled syringe) are used to treat neutropenia, low neutrophils which are a type of w
BOSTON--(BUSINESS WIRE)--Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today the opening of its new global headquarters at 180 Third Avenue in Waltham, Mass. The new 37,811 square-foot space will serve as the company’s hub for innovation, operations and commercialization, supporting company growth and further development of its novel device for pulsatile intravascular lithotripsy (PIVL), the P
PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced that following a pre-specified interim efficacy analysis for the Phase 2 FORTE basket study evaluating plixorafenib as a monotherapy in patients with recurrent or progressive BRAF V600-mutated primary central nervous system (CNS) tumors, the Independent Data Monitoring Committee (IDMC) has recommended that the
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Pi Health, a global health technology and clinical research company, today announced it will provide fully outsourced clinical research services in a GSK clinical trial with the aim of significantly improving the time and efficiency of the clinical trial process. Pi Health and GSK have executed a Master Clinical Services Outsourcing Agreement for the collaboration and have begun initial activities for a global Phase 2 oncology clinical trial. Pi Health will ma
WOODBRIDGE, Conn.--(BUSINESS WIRE)--Cure Rare Disease (CRD), a 501(c)(3) nonprofit biotechnology company developing genetic therapies for ultra-rare neuromuscular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its investigational therapy, CRD-003, for the treatment of congenital muscular dystrophy caused by biallelic mutations in the FKRP gene (Limb-Girdle Muscular Dystrophy Type R9, LGMD2i/R9). The investigational therap
ATLANTA--(BUSINESS WIRE)--Mirion (“we” or the “company”) (NYSE: MIR), a global provider of radiation detection, measurement, analysis, and monitoring solutions to the nuclear, medical, defense, and research end markets, has entered into a definitive agreement to acquire Paragon Energy Solutions (“Paragon”), one of the leading providers of highly engineered solutions for the nuclear power industry, from Windjammer Capital Investors for approximately $585 million in cash. “I look forward to welco
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 COMPASS PWS trial evaluating the efficacy and safety of intranasal carbetocin (ACP-101) in patients with hyperphagia in Prader-Willi syndrome (PWS). Intranasal carbetocin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), nor was
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improv
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aera Therapeutics, a biotechnology company harnessing next-generation enabling delivery technologies and precision payloads to unlock the full potential of genetic medicines, today presented preclinical data at the 10th Annual CAR-TCR Summit supporting the nomination of AERA-109, a targeted in vivo CAR-T therapy designed to treat multiple B cell-mediated autoimmune diseases, as the company’s first development candidate. Data outlined in the presentation demons
MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that data from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be featured as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) which takes place from October 17
SAN CARLOS, Calif.--(BUSINESS WIRE)-- #biosciences--Mispro to expand in the Bay Area with full-service contract vivarium in San Carlos.
|
Print Page
