Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle...Read more
First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy DATROWAY is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030 WILMINGTON, Del. / Jan 17, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with...Read more
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone First and only BTK inhibitor approved for the 1st-line treatment of MCL in the US WILMINGTON, Del. / Jan 17, 2025 / Business Wire / AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with...Read more
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as...Read more
CAMBRIDGE, MA / ACCESS Newswire / January 17, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The award was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS...Read more
SHANGHAI & CAMBRIDGE, Mass. / Jan 17, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. “There are more than 8 million patients living with schizophrenia in China who face significant unmet needs due to the limited efficacy and undesirable side...Read more
The New Drug Application is based on positive results from the Phase 3 PALISADE study People living with familial chylomicronemia syndrome have extremely high triglyceride levels and a substantially higher risk of developing acute pancreatitis and associated long-term complications, including poor quality of life PASADENA, Calif. / Jan 17, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the...Read more
Highlights from Castle’s DecisionDx-SCC poster will be shared in a special podium presentation during the Late Breakers 2025 session on Tuesday, Jan. 21, from 10:45-11:15 a.m. local time FRIENDSWOOD, Texas / Jan 17, 2025 / Business Wire / Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share data supporting its dermatologic portfolio of tests for skin cancer,...Read more
LONDON, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai'i...Read more
RA'ANANA, ISRAEL, Jan. 17, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, has announced that the Company is establishing a dedicated production line for a crucial component of its innovative respiratory support system, in collaboration with Zriha Medical Ltd ("Zriha Medical"), a leading international manufacturer specializing in...Read more
AUSTIN, Texas / Jan 17, 2025 / Business Wire / ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) today announced the launch of its AI-powered pipeline of both optimized and new therapeutics, a system set to transform therapeutic development. By combining advanced artificial intelligence with first-principles thinking, the BioStrand pipeline reimagines drug discovery, offering unmatched speed, precision, and transparency. Traditional drug...Read more
Sales Highlights: Global December 2024 Quarter AUD$2.5 million up 70% on prior quarter, up 249% on pcp December 2024 Half Year AUD$4.0 million up 70% on pcp Australia December 2024 Quarter AUD$1.9 million up 83% on prior quarter, up 314% on pcp December 2024 Half Year AUD$2.9 million up 54% on pcp North America December 2024 Quarter AUD$0.7 million up 43% on prior quarter, up 141% on pcp December...Read more
Revenues of $400.3 Billion Grew 8% Year-Over-Year Domestic Consumers Served by UnitedHealthcare Grew 2.1 Million Value-Based Care Patients Served by Optum Grew 600,000 Cash Flows from Operations were $24.2 Billion or 1.6x Net Income Full Year, Fourth Quarter Net Earnings were $15.51, $5.98 Per Share Full Year, Fourth Quarter Adjusted Net Earnings were $27.66, $6.81 Per Share Company Affirms 2025 Performance Outlook - / Jan 16,...Read more
Phase 3 MARIPOSA-2 study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival compared to carboplatin and pemetrexed alone.1 TORONTO, Jan. 16, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab for injection) in combination with carboplatin and pemetrexed (platinum-based...Read more
First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System Sub-analysis from OPTION clinical trial highlights consistent safety and efficacy outcomes with the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation in both concomitant and sequential...Read more
Complete fourth quarter and full-year 2024 financial results will be announced on Tuesday, February 25, 2025 IRVINE, Calif. / Jan 16, 2025 / Business Wire / Masimo Corporation (Nasdaq: MASI) today announced select preliminary financial results for the fourth quarter and full-year ended December 28, 2024 and provided estimates for its full-year 2025 guidance. Preliminary Fourth Quarter 2024 Financial Results: Consolidated revenue is...Read more
WILMINGTON, Mass. / Jan 16, 2025 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) and Akron Bio (“Akron”), a leading supplier of critical materials and services for advanced therapies, today announced the integration of Akron’s Closed System Solutions (CSS)™ line of liquid cytokines produced under current good manufacturing practices (CGMP) onto Charles River’s Cell Therapy Flex Platform for Process Development....Read more
MELBOURNE, Australia and LIÈGE, Belgium, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP). This...Read more
Collaboration enables insights from ConcertAI national database of 5.5M clinical records and Guardant profiling data across 60+ tumor types Longitudinal DNA methylation measurements and comprehensive genomic profiling allow deeper insights into intrinsic and acquired resistance mechanisms PALO ALTO, Calif., & CAMBRIDGE, Mass. / Jan 16, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,...Read more
LANSING, Mich., Jan. 16, 2025 /PRNewswire/ -- Neogen® Corporation (NASDAQ: NEOG), an innovative leader in food safety solutions, announced today the launch of the new Neogen Molecular Detection Assay 2 – Quantitative Salmonella (MDA2QSAL96). The Neogen MDA2QSAL96 kit integrates qualitative pathogen testing solutions and Quantitative Rapid Enrichment Dehydrated (QRED) media designed to enable controlled growth rates for quantitation,...Read more
NEW YORK, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Progyny, Inc. (Nasdaq: PGNY), a transformative fertility, family building and women’s health benefits solution, today announced the appointment of 30-year healthcare industry veteran Debra Morris to its board of directors, effective January 16, 2025. Debra Morris currently serves as President of AccessHope, a company changing the way leading-edge cancer expertise is delivered. Previously she...Read more
– Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA – Sensitivity analyses support the results of the primary endpoint analysis, with representative sensitivity analyses demonstrating: Narsoplimab-treated patients had an over 2-fold reduction (hazard ratio = 0.42 [95% confidence interval: 0.21, 0.83]) to an over 4-fold reduction...Read more
ADDIS ABABA, Ethiopia and KINSHASA, Democratic Republic of the Congo and WASHINGTON and PARIS, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Africa CDC’s support for the MOSA, a pan-African randomized platform adaptive trial for the MpOx Study, adding to the initial EU funding, has enabled the enrollment of the first patients at Mbandaka Hospital in Equateur Province, Democratic Republic of Congo (DRC). These patients have been randomized in this...Read more
REDWOOD CITY, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced the appointment of Christos Richards to the Company’s Board of Directors. “I am delighted to welcome Christos to our Board. His broad and deep knowledge and understanding of the life sciences industry will be invaluable as we continue the...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeks BLA resubmission on track for calendar Q1 2025 Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the...Read more
Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to...Read more
FemaSeed® patent application provides additional coverage for Femasys’ therapeutic option for women seeking infertility solution ATLANTA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces the United States Patent and...Read more
10-Minute PSA Test for Early Detection of Prostate Specific Antigen (PSA), an Early Warning Sign of Prostate Cancer Prostate Cancer: The Second Most Common Cancer in Men Globally IRVINE, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of innovative diagnostic solutions, is proud to announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the...Read more
Initial plans target European clinical trials while providing standard testing to clinicians for individual patients There are an estimated 250,000 gynecologic cancers diagnosed annually across Europe PITTSBURGH, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery, today announced plans to launch its validated flagship live cell ChemoFx® drug response assay in Europe...Read more
Vancouver, British Columbia--(Newsfile Corp. - January 16, 2025) - Kovo+ Holdings Inc. (TSXV: KOVO) (formerly Kovo HealthTech Corporation) ("Kovo" or the "Company") is pleased to announce that it has entered into a strategic partnership with Open Practice Solutions, LTD ("Open Practice"), a leading provider of practice management software. This partnership will enable Kovo to utilize Open Practice Solutions' OpenPM Billing Service...Read more
Calgary, Alberta--(Newsfile Corp. - January 16, 2025) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF), and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), today is pleased to announce that the Chinese patent office has issued a notice of allowance for its lead compound MB-204. This is the first allowance worldwide for this family. "We are pleased with this allowance of claims to...Read more
PRINCETON, N.J., Jan. 16, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming conferences below. Sequire Investor Summit, held January 21 to 23 at Condado...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 16, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 610,000 shares of its common stock...Read more
Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a...Read more
Woburn, Massachusetts--(Newsfile Corp. - January 16, 2025) - iSpecimen Inc. (NASDAQ: ISPC), a leading online marketplace for human biospecimens, has secured suppliers for the flu-like human metapneumovirus (hMPV). The virus has been causing hospitals in China to become overrun, raising the potential for another COVID-style pandemic. iSpecimen is a market leader in the biospecimen space and leverages its vast network of suppliers to...Read more
In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical remission and endoscopic response at one year Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension INDIANAPOLIS, Jan. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1 RARITAN, N.J., Jan. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus...Read more
SUNNYVALE, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Intuitive (the “Company”) (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced certain unaudited preliminary fourth quarter and full year 2024 financial results ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. Financial and Operational Highlights Fourth...Read more
New, Fully Automated, High-Throughput RUO Assays offered on Beckman Coulter Immunoassay Analyzers BREA, Calif., Jan. 15, 2025 /PRNewswire/ -- Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and...Read more
FRANKLIN LAKES, N.J., Jan. 15, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced additional investments in its U.S. manufacturing network to add capacity for critical medical devices, including syringes, needles and IV catheters, to meet the ongoing needs of the nation's health care system. As part of the company's 2024 investment of more than $10...Read more
New joint research program combines UCSF’s advanced clinical and research teams with GE HealthCare’s technical and engineering expertise to develop solutions that directly impact patient care. The collaboration aims to address two of the most prevalent disease states worldwide, neurodegenerative disease and cancer, by increasing accessibility of imaging, driving clinical impact and translating techniques to diagnose and treat these...Read more
Company to provide comprehensive update in a presentation delivered today at the 43rd Annual J.P. Morgan Healthcare Conference Presentation outlines strength of existing oncology portfolio, along with pipeline of new products and data readouts AUSTIN, Texas / Jan 15, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, will provide an update to the investment community, today, at the 43rd...Read more
CHICAGO / Jan 15, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians nationwide. xT CDx is a FDA-approved test that delivers comprehensive insights with one of the...Read more
Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population The safety profile of TIVDAK among the China subpopulation was manageable and consistent with that observed in the global population Zai Lab intends to submit a New Drug Application (NDA) to China’s...Read more
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in partnership with Serum Institute of India: Anticipated submission for market access as an alternative source in Q1 2025 Second- and third-line non-small cell lung cancer (NSCLC) progressing on checkpoint inhibitors (QUILT-3.055): Anticipated...Read more
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization application for BCG Unresponsive NMIBC CIS submitted to United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024 and anticipated acceptance...Read more
Full-Year 2024 Revenue of $384.4 million, Bookings of $445.3 million Confirms Adjusted EBITDA within Guidance Range of $120 million to $124 million RADNOR, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced revenue and bookings for the fourth quarter and full year of fiscal year 2024 based on a preliminary review of fourth quarter...Read more
Long-Range Plan reflects 12-13% revenue growth annually Presentation and webcast at 43rd Annual J.P. Morgan Healthcare Conference today, Wednesday, January 15, at 1:30 p.m. PT / 4:30 p.m. ET FT. MYERS, Fla. / Jan 15, 2025 / Business Wire / NeoGenomics, Inc. (“NeoGenomics” or the “Company”) (NASDAQ:NEO), a leading oncology testing services company, today provided financial guidance for fiscal year 2025 and updated its Long-Range...Read more
SALT LAKE CITY, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced select unaudited preliminary results for the fourth quarter and full year ended December 31, 2024, and provided full year 2025 financial guidance. Select Preliminary Fourth Quarter and Full Year 2024 Financial Results The company expects the following: Fourth quarter of 2024 total...Read more
U.S. launch expected in early February Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis Pivotal data from the AGAVE-201 trial supporting FDA approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups WILMINGTON, Del. and WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Incyte (Nasdaq:INCY)...Read more
Blarcamesine potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement Impairment of autophagy precedes both amyloid beta and tau tangles, and therefore anticipates the neurodegenerative process in Alzheimer’s disease NEW YORK, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused...Read more
FREMONT, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced preliminary, unaudited revenue results for the full year ended December 31, 2024. Cytek expects its full year revenue for 2024 to be between $200 million and $201 million, representing 4% growth over Cytek’s 2023 revenue of $193.0 million. This included a negative foreign exchange impact of...Read more
LEXINGTON, Mass., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has voluntarily halted all dosing...Read more
ENVISION Reports 79.6% Complete Response Rate at 3 Months, 82.3% Duration of Response at 12 Months, and Consistent Safety Profile PRINCETON, N.J. / Jan 15, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the 3-month complete response (CR) rate and 12-month durability of response...Read more
New executive leadership supports the company’s transition to a fully integrated commercial-stage organization in a year of transformative growth with a potential new product launch in mid-2025. BOSTON / Jan 15, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the appointment of Matthew E. Ros as...Read more
Strategic Partnership Agreements will facilitate collaboration among sites, cultivate long term partnerships, enhance efficiency in trial operations, and improve overall site performance First program member is Segal Trials, a preferred provider for leading pharmaceutical companies globally Phase 2 data confirmed that two 16 mg doses of CYB003 administered three weeks apart provides remission from depression symptoms for 12 months in...Read more
JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome...Read more
BOSTON and SAN FRANCISCO, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Amwell® (NYSE: AMWL), a leader in digital care, today announced that Vida Health, a leader in virtual cardiometabolic care, is now part of the clinical programs portfolio on the Amwell platform. The program, Amwell Cardiometabolic Care Powered by Vida, will be available to Amwell’s expansive client footprint of health plans and employers. Clients will be able to offer their...Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 15, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) recently completed a listing agreement with British Columbia's Provincial Health Services Authority (PHSA), a publicly funded health service provider in the Canadian province, for a new approved indication for Trecondyv® (treosulfan for injection) to be listed on the BC Cancer Benefit Drug List and funded through...Read more
EMERYVILLE, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today announced that Eric Bjerkholt, MBA, CFO of Mirum Pharmaceuticals, Inc., will join Metagenomi’s Board of Directors, serving on Metagenomi’s Audit and Compensation committees, effective January 27, 2025. “We...Read more
YARDLEY, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced preliminary unaudited XHANCE® (fluticasone propionate) net product revenue of $22.4 million for the three months ended December 31, 2024. “Our preliminary unaudited fourth quarter net product revenue of $22.4 million is in line with our...Read more
The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (33.3%) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20%) Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical control 100% of...Read more
New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the...Read more
WILMINGTON, Del., Jan. 15, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., a development stage medical and technology driven company and wholly owned subsidiary of NRx, today announced the appointment of Mr. Michael Taylor and Ms. Anita Nunes as Member and Observer of its Board of Directors, respectively. ...Read more
BASKING RIDGE, N.J., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that David J. Mazzo, PhD, President and Chief Executive Officer of Lisata, will present a corporate overview at the upcoming Sequire Investor Summit being held January 21-23,...Read more
Trial remains on track for completion and data readout in the second half of 2025 COPENHAGEN, Denmark, January 15, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a...Read more
VANCOUVER, British Columbia, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) is excited to announce that its cutting-edge anti-aging compound, TFC-1326, has been highlighted in Stonegate Healthcare Partners’ latest research report. The publication, titled "Sirona Biochem’s TFC-1326 Clinical Data Versus Retinoid Clinical Data," provides an extensive evaluation of TFC-1326’s clinical trial...Read more
Highlights: New Research Collaboration with Monash University One proposal will target Antimicrobial Resistant Pathways to develop broad spectrum therapeutic drug products Second project proposal will focus on the Develop of new therapeutic drug candidates against Vancomycin-resistant enterococci (VRE) MELBOURNE, Australia, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and...Read more
Total Revenue Increases 5% Year-Over-Year Achieves Sustained Revenue Growth, Improved Gross Margins, and Significant Cost Savings IRVINE, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the second quarter of fiscal 2025 ended November 30, 2024. Key Highlights: Direct-to-Consumer...Read more
Company to report on progress with clinical trials to be initiated in 2025 and expected milestones ATLANTA / Jan 15, 2025 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company, focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 15, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 833,335 shares of its common stock...Read more
EDINBURGH, Scotland, Jan. 15, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB008, for treatment in H5N1, commonly known as "Bird Flu." The Company is...Read more
Vancouver, British Columbia – TheNewswire - 15 January, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a clinical stage biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines to treat depressive disorders. The Company is delighted to provide an update on clinical trial progress and technology developments. MindBio is currently...Read more
WARRINGTON, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of a patent in Japan for “Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers.” The patent number is...Read more
Set to begin larger Phase 2b study in sarcopenia and new trial in GLP-1-induced sarcopenia and frailty Transformative potential for novel TNF-alpha inhibitor drug: Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market BALTIMORE / Jan 15, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral...Read more
2024 revenue is expected to be approximately $45.0 billion for the full year, $4.0 billion above the midpoint of first-time 2024 financial guidance Q4 2024 revenue is expected to be approximately $13.5 billion, approximately $400 million below the low end of recently issued financial guidance The company anticipates 2025 revenue to be in the range of $58.0 billion to $61.0 billion, growth of 32% at the midpoint compared to...Read more
The multi-year collaboration enables expanded access to quality diagnostic care for patients in California and provides Sutter physicians and clinicians with access to technology advances and innovations. It will also drive ongoing, comprehensive training and education, fostering future healthcare professionals representing the diverse communities they serve. Sutter Health, one of the top integrated health delivery systems in the country...Read more
SAN DIEGO, Jan. 14, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) ("Illumina" or the "company") today announced unaudited preliminary financial results for the fourth quarter and fiscal year 2024 and preliminary outlook for fiscal year 2025 ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025 at 9:00 a.m. Pacific Time (12:00 p.m. Eastern Time). The webcast can be accessed through...Read more
Highlights Full year 2025 revenue guidance in the range of $8,050 - $8,650 million; midpoint of $8,350 million representing growth of approximately 1% over full year 2024 revenue guidance midpoint. Full year 2025 adjusted earnings per share* guidance in the range of $13.00 - $15.00; midpoint of $14.00, flat over full year 2024 adjusted earnings per share guidance midpoint. With respect to full year 2024, the company reaffirmed its...Read more
ALISO VIEJO, Calif. / Jan 14, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform, including: In a new 36-month follow-up analysis of its two Phase 3 pivotal...Read more
CHICAGO / Jan 14, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today introduced a suite of new, transformative capabilities available in Tempus One, the company’s generative AI assistant. Tempus One, which initially launched in 2023, provides both physicians and researchers AI-enabled services that leverage generative AI to propel...Read more
Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million NEW YORK, Jan. 14, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), yesterday announced preliminary U.S. net product revenue for BRIUMVI® for...Read more
CLEVELAND, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Sotera Health Company (“Sotera Health” or the “Company”) (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry, is presenting today at the 43rd Annual J.P. Morgan Healthcare Conference. During the presentation, Chairman and CEO Michael B. Petras, Jr. will be providing an update on Sotera...Read more
Full-Year 2024 Total Revenue Growth of 20% and Adjusted EBITDA Growth of Approximately 55% MACI Full-Year 2024 Revenue Growth of 20%, with Fourth Quarter Revenue of $68.2 to $68.7 Million Highest Quarterly MACI Implants, Surgeons, and Biopsies Since Launch and Strong Early MACI Arthro Launch Indicators Record Fourth Quarter Gross Margin of Approximately 77% and Adjusted EBITDA Margin of 39% 2025 Total Revenue Guidance of 20% to 23%...Read more
Filing marks company’s first Marketing Authorization Application in Europe SAN DIEGO / Jan 14, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. If granted marketing authorization,...Read more
‘Chronos-PD’ is looking for biological signals that could indicate increased chance of developing Parkinson’s disease (PD) years before symptoms appear, leading to new diagnostic tools and disease-modifying therapies Part of broad Grifols program to find disease-revealing clues in more than 100 million proprietary plasma samples connected to real-world data on thousands of disease states in many therapeutic areas Cutting-edge use of...Read more
311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
SEATTLE and FORT MYERS, Fla., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and NeoGenomics, Inc. (Nasdaq:NEO), a leading oncology testing services company, today announced a multi-year exclusive strategic commercial collaboration that will...Read more
Alongside over-the-counter NARCAN® Nasal Spray 4 mg, prescription KLOXXADO® (naloxone HCl) Nasal Spray 8 mg will expand Emergent’s ability to distribute multiple life-saving opioid overdose emergency treatments to patients, customers and communities in need Focus remains on increasing access, raising awareness and ensuring strong supply to meet the ongoing demand of naloxone nasal spray GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE...Read more
MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading provider of highly accurate long-read sequencing solutions, announced a significant publication from Radboud University Medical Center (Radboudumc) and its research partners in the American Journal of Human Genetics. The study demonstrates the impact of PacBio’s HiFi long-read sequencing technology in identifying genetic causes of rare diseases,...Read more
Commenced shipment of the Vega™ benchtop system ahead of schedule, bringing HiFi sequencing to more customers Launched SPRQ chemistry, enabling the sub-$500 HiFi genome on the Revio® system MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, announced preliminary unaudited revenue for the fourth quarter of 2024 and full year 2024 of...Read more
REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturing Nippon Shinyaku to lead commercialization of first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in U.S. and Asia REGENXBIO retains rights to RGX-121 Priority Review Voucher (PRV) with potential accelerated approval...Read more
Cemsidomide Data Presented at American Society of Hematology (ASH) Annual Meeting Support Best-in-Class Profile; Program Advancing to Next Phase of Clinical Development in Multiple Myeloma and Non-Hodgkin’s Lymphoma CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025; Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025 CFT8919...Read more
VS-7375 is a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1 development in China in advanced KRAS G12D mutant solid tumors; Verastem anticipates filing a U.S. IND application for VS-7375 during Q1 2025 and expects to initiate a Phase 1/2a study mid-2025 License establishes global development and commercialization rights for Verastem for VS-7375 outside of China, Hong Kong, Macau, and...Read more
NATICK, Mass. / Jan 14, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced that it has entered into a subscription agreement with funds affiliated with RTW Investments, LP (“RTW”) for the purchase and sale of 841,751 shares of the Company’s common stock in a private placement at a purchase price of $2.97 per share. The private placement is...Read more
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical...Read more
STAFFORD, Texas, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the initiation of clinical sites in Germany. The Company has partnered with GBG (German Breast Group), the largest academic breast...Read more
MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients' lives, today reported select preliminary, unaudited financial highlights for the fourth quarter and full year ended December 31, 2024. Select Preliminary Financial...Read more
ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025 Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with...Read more
VANCOUVER, British Columbia & DALLAS / Jan 14, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced the strategic appointments of Jen Pesa, Vice President of Commercial; Jack Kelly, Head of Market Access; Rommel Fernandez, Vice President of Corporate Strategy and...Read more
Full year 2024 reported revenue growth of at least 15% compared to 2023 BOSTON / Jan 14, 2025 / Business Wire / 908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical analysis, today announced preliminary unaudited financial results for the quarter and full year ended December 31, 2024. Preliminary unaudited revenue for the fourth quarter of 2024 is expected to be approximately $17.2...Read more
First FDA-Cleared Antibiotic-Eluting BioEnvelope Now Available in U.S. for Implantable Pacemakers, Defibrillators, and Neurostimulators SILVER SPRING, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT), a pioneer in drug-eluting biomatrix technologies, announced the U.S. commercial launch of EluPro™, the first and only FDA-cleared antibiotic-eluting biomatrix designed for use with cardiac implantable electronic devices...Read more
HALIFAX, NS / ACCESSWIRE / January 14, 2025 / MedMira Inc. (MedMira) (TSXV:MIR) announced today that it has received today the approval from Health Canada for its Reveal®Rapid G4 HIV-1/2 Test (Reveal® HIV test) for Point-of-Care (POC) use. The Reveal® HIV rapid test has achieved a sensitivity of 99.64% and a specificity of 99.71% and with it is highly suitable for health care professionals who require a fast, reliable, and high-quality...Read more
SAN DIEGO and SUZHOU, China, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who...Read more
PH284 nasal spray demonstrated improvements to subjective feelings of hunger in cancer patients PH284 is the fifth pherine product candidate in Vistagen’s neuroscience pipeline with a positive efficacy signal SOUTH SAN FRANCISCO, Calif. / Jan 14, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from...Read more
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
HUNTSVILLE, AL, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug delivery technology, today announced the appointment of Karen J. Wilson to the Board of Directors. "We are excited to welcome Karen to the Board of Directors. Karen’s financial expertise and deep understanding of the biotech landscape will play a...Read more
Fourth quarter 2024 total revenue expected to be a record at approximately $8.2 million, representing growth of approximately 30% compared to the prior-year period. Fourth quarter 2024 recurring revenue expected to be approximately $4.2 million, representing growth of approximately 27% compared to the prior-year period. Full year 2024 total revenue expected to be approximately $28.1 million, representing growth of approximately...Read more
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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