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
Pharmaceuticals and Drug Development Lib Dem MP weighs in on British scientific innovation On National Manufacturing Day, September 28, Twickenham MP Munira Wilson met with locally based Easyfairs, the organisers of the UK’s largest trade annual trade shows for the laboratory and engineering industries: Lab Innovations and Advanced Engineering. Munira – who is also the Liberal Democrat education spokesperson – discussed the need for greater recruitment and education […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom October 22, 2023October 22, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents NEW YORK–(BUSINESS WIRE) October 20, 2023 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, […] Written by Admin October 21, 2023October 21, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for Udenyca ® OnBody™ Generic name: pegfilgrastim-cbqvTreatment for: Neutropenia Associated with Chemotherapy Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for Udenyca ® OnBody™ REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, the company’s on-body injector […] Written by Admin October 20, 2023October 20, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Enzalutamide + Leuprolide Top for Mets-Free Survival in Prostate Cancer By Elana Gotkine HealthDay Reporter WEDNESDAY, Oct. 18, 2023 — For patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide is best for metastasis-free survival, according to a study published in the Oct. 19 issue of the New England Journal of Medicine. Stephen J. Freedland, M.D., from the Cedars-Sinai Medical Center in Los […] Written by Admin October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Lab Innovations announces this year’s keynote speakers Philbin, a renowned TV presenter and science and technology advocate, will take to the stage at the RSC theatre at 1 pm on day one of Lab Innovations. She will discuss the reasons behind her passion for innovation in the lab industry and share an insight into some of the latest projects to catch her […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis Brussels (Belgium), 18 OCTOBER 2023 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for […] Written by Admin October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Sun Pharma Announces US FDA Filing Acceptance of New Drug Application for Deuruxolitinib Treatment for: Alopecia Areata Sun Pharma Announces US FDA Filing Acceptance of New Drug Application for Deuruxolitinib Mumbai, INDIA and Princeton, N.J., October 06, 2023 – Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) today announced that the U.S. Food and […] Written by Admin October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Pulitzer Prize-Winning Writer Elizabeth Kolbert Is Cataloging the Climate Crisis – State of the Planet As a staff writer for The New Yorker since 1999, Elizabeth Kolbert has spent decades informing the reading public about the science of our changing planet, the complicated part humans have played in climate change and the possible solutions for our future. Kolbert has traveled the world in pursuit of these stories, written countless essays […] Written by Olga Rukovets February 22, 2025February 22, 2025 Saving Bookmark this article Bookmarked
Researchers outline new approach for better understanding animal consciousness A team of researchers has outlined a new approach for better understanding the depths of animal consciousness, a method that may yield new insights into the similarities and differences among living organisms. The essay, which appears in the journal Science, describes a “marker method” that scientists can use to assess animal consciousness. It involves identifying […] Written by Admin February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Pulitzer Prize-Winning Writer Elizabeth Kolbert Is Cataloging the Climate Crisis – State of the Planet As a staff writer for The New Yorker since 1999, Elizabeth Kolbert has spent decades informing the reading public about the science of our changing planet, the complicated part humans have played in climate change and the possible solutions for our future. Kolbert has traveled the world in pursuit of these stories, written countless essays […] Written by Olga Rukovets February 22, 2025February 22, 2025 Saving Bookmark this article Bookmarked
Researchers outline new approach for better understanding animal consciousness A team of researchers has outlined a new approach for better understanding the depths of animal consciousness, a method that may yield new insights into the similarities and differences among living organisms. The essay, which appears in the journal Science, describes a “marker method” that scientists can use to assess animal consciousness. It involves identifying […] Written by Admin February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Unveiling the Elasticity Secrets of Flexible Crystals Australian researchers have achieved significant breakthroughs in understanding the intrinsic properties of flexible crystalline materials, paving the way for potential advancements in the fields of building materials, electronics, and various technologies. The research team, which includes experts from The University of Queensland (UQ) and Queensland University of Technology (QUT), focused their investigation on the elastic […] Written by Bioengineer February 21, 2025February 21, 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