Pharmaceuticals and Drug Development Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) Treatment for: Low-Grade Glioma Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) BRISBANE, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people […] Written by Admin November 1, 2023November 1, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Sociodemographic Disparities Seen in Quality of Life in Children With Hearing Loss By Lori Solomon HealthDay Reporter TUESDAY, Oct. 31, 2023 — Race and ethnicity and neighborhood disadvantage are associated with hearing-related quality of life (QOL) in deaf or hard-of-hearing (DHH) children, according to a research letter published online Oct. 30 in JAMA Network Open. Brooke R. Warren, from the University of California in San Francisco, and […] Written by Admin October 31, 2023October 31, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Driving Precision Medicine Forward: Bio-It World Europe Convenes in London 29-30 November 2023 LONDON—To foster collaboration among the UK and Europe’s biopharma and technology leaders who are forging new frontiers in precision medicine, the Bio-IT World Conference & Expo Europe is coming to London 29-30 November 2023. Held in one of the world’s leading hubs for medical innovation, this annual event will focus on the latest IT […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom October 30, 2023October 30, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist […] Written by Admin October 29, 2023October 29, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review Treatment for: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority […] Written by Admin October 28, 2023October 28, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development TCT: TAVR, SAVR Comparable for Severe Aortic Stenosis, Small Aortic Annulus By Elana Gotkine HealthDay Reporter FRIDAY, Oct. 27, 2023 — For patients with severe aortic stenosis (AS) and small aortic annulus (SAA), valve hemodynamic results are comparable with use of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), according to a study published online Oct. 26 in Circulation to coincide with the […] Written by Admin October 27, 2023October 27, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Going green in pharmaceuticals London, 25/10/2023: The pharmaceutical industry is currently responsible for over four per cent of global carbon emissions and this figure is on track to grow in the coming years. The UK Government has committed in legislation to reach net-zero carbon emissions by 2050, but achieving this goal could hinge on whether or not the industry […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom October 26, 2023October 26, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People With Inflammatory Bowel Disease FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People With Inflammatory Bowel Disease JERSEY CITY, N.J.–(BUSINESS WIRE) October 23, 2023 –Today, Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) […] Written by Admin October 25, 2023October 25, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole Treatment for: Skin and Structure Infection Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024 Allschwil, Switzerland, […] Written by Admin October 24, 2023October 24, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Study Looks at Palliative Care Use in Adolescents, Young Adults With Cancer By Elana Gotkine HealthDay Reporter FRIDAY, Oct. 20, 2023 — For adolescents and young adults (AYA) with cancer, the likelihood of receiving specialty palliative care (SPC) is increased for those reporting moderate or severe symptoms, according to a study published online Oct. 20 in JAMA Network Open. Sumit Gupta, M.D., Ph.D., from The Hospital for […] Written by Admin October 23, 2023October 23, 2023 Saving Bookmark this article Bookmarked
700,000 years ahead of their teeth: The carbs that made us human As early humans spread from lush African forests into grasslands, their need for ready sources of energy led them to develop a taste for grassy plants, especially grains and the starchy plant tissue hidden underground. But a new Dartmouth-led study shows that hominins began feasting on these carbohydrate-rich foods before they had the ideal teeth […] Written by Admin August 3, 2025August 3, 2025 Saving Bookmark this article Bookmarked
Dental Stem Cells Differentiate on Biodentine Nanofibers In a groundbreaking advance within the field of regenerative medicine, researchers have unveiled a novel approach to enhance dental and bone tissue engineering by leveraging the unique properties of dental pulp stem cells (DPSCs) cultured on specially designed polymer nanofibers. The study, recently published in BioMedical Engineering OnLine, explores the odontogenic and osteogenic potential of […] Written by Bioengineer August 2, 2025August 2, 2025 Saving Bookmark this article Bookmarked
700,000 years ahead of their teeth: The carbs that made us human As early humans spread from lush African forests into grasslands, their need for ready sources of energy led them to develop a taste for grassy plants, especially grains and the starchy plant tissue hidden underground. But a new Dartmouth-led study shows that hominins began feasting on these carbohydrate-rich foods before they had the ideal teeth […] Written by Admin August 3, 2025August 3, 2025 Saving Bookmark this article Bookmarked
Dental Stem Cells Differentiate on Biodentine Nanofibers In a groundbreaking advance within the field of regenerative medicine, researchers have unveiled a novel approach to enhance dental and bone tissue engineering by leveraging the unique properties of dental pulp stem cells (DPSCs) cultured on specially designed polymer nanofibers. The study, recently published in BioMedical Engineering OnLine, explores the odontogenic and osteogenic potential of […] Written by Bioengineer August 2, 2025August 2, 2025 Saving Bookmark this article Bookmarked
Can Tariffs Lead to a More Circular Economy? – State of the Planet As global trade tensions mount and countries recalibrate their economic priorities, tariffs may have the ability to play an unexpected role in the sustainability conversation. Tariffs on imports, while often viewed as controversial and protectionist weapons, could paradoxically drive the shift not only toward less production, but also toward more localized, circular and environmentally conscious […] Written by Guest August 2, 2025August 2, 2025 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked