Pharmaceuticals and Drug Development Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease Treatment for: EBV-Positive Post-Transplant Lymphoproliferative Disease Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease THOUSAND OAKS, Calif.–(BUSINESS WIRE) July 17, 2024 — Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic […] Written by Admin July 31, 2024July 31, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Body Composition Patterns Linked to Risk of Neurodegenerative Diseases Medically reviewed by Drugs.com. By Elana Gotkine HealthDay Reporter WEDNESDAY, July 24, 2024 — Specific body composition patterns are associated with neurodegenerative diseases and brain aging, according to a study published online July 24 in Neurology. Shishi Xu, M.D., Ph.D., from the West China Hospital of Sichuan University in Chengdu, and colleagues conducted a retrospective […] Written by Admin July 25, 2024July 25, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Vilnius University Scientists’ Research on Bacterial Defense from Viruses Was Published in Science CRISPR-Cas systems provide interference against invading foreign nucleic acids by different mechanisms. In bacteria, several different types of antiviral CRISPR-Cas systems are found, which differ in Cas proteins and their functions. Currently, the best-known Cas9 and Cas12 proteins are widely used as genome editing tools. A team of researchers led by Gintautas Tamulaitis is studying […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom July 19, 2024July 19, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic […] Written by Admin July 13, 2024July 13, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN Treatment for: Neurofibromatosis SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has […] Written by Admin July 7, 2024July 7, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Monthly News Roundup – June 2024 Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on June 30, 2024. FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis (UC). Skyrizi is also approved to treat adults with plaque […] Written by Leigh Ann Anderson July 1, 2024July 1, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development New study from the RVC explores malaria invasion to help develop life-saving vaccine Malaria is a deadly disease caused by the Plasmodium parasite which infects more than 200 million people a year, causing approximately 600,000 deaths annually worldwide with young children in Africa disproportionately affected. With numbers of infections expected to rise in the coming years due to growing parasite resistance to frontline anti-malarial drugs, there is a […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom June 25, 2024June 25, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Skyrizi (risankizumab-rzaa) for Ulcerative Colitis NORTH CHICAGO, Ill., June 18, 2024 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease.3 Skyrizi […] Written by Admin June 19, 2024June 19, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment) Generic name: lacosamideTreatment for: Seizures New Indication for Motpoly XR New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment) SILVER SPRING, MD. June 7, 2024/FDA Approvals/ — Today, the U.S. Food and Drug Administration (FDA) granted Aucta Pharmaceuticals a prior approval supplemental new drug application for the use of […] Written by Admin June 13, 2024June 13, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development CDC Urges Clinicians to Remain on the Lookout for Mpox Virus Infections Medically reviewed by Drugs.com. By Elana Gotkine HealthDay Reporter THURSDAY, June 6, 2024 — Among emergency department patients evaluated for an mpox-compatible rash, the prevalence of mpox is 1.5 percent, according to research published in the June 6 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. Carl T. […] Written by Admin June 7, 2024June 7, 2024 Saving Bookmark this article Bookmarked
Mammals didn’t walk upright until late—here’s what fossils reveal For over a century, scientists have puzzled over a fundamental mystery in our evolutionary history: how did mammals go from sprawling like lizards to striding like cats and dogs? This transition — from a sprawled stance (like a lizard) to an upright (parasagittal) posture — marked a pivotal moment in mammal evolution. While the earliest […] Written by Admin June 30, 2025June 30, 2025 Saving Bookmark this article Bookmarked
A coordinated kinase and phosphatase network regulates Stu2 recruitment to yeast kinetochores Cells coordinate diverse events at anaphase onset, including separase activation, cohesin cleavage, chromosome separation, and spindle reorganization. Regulation of the XMAP215 family member and microtubule polymerase, Stu2, at the metaphase-anaphase transition determines a redistribution from kinetochores to spindle microtubules. We show that cells modulate Stu2 kinetochore-microtubule localization by Polo-like kinase1/Cdc5-mediated phosphorylation of T866, near the […] Written by Admin June 29, 2025June 29, 2025 Saving Bookmark this article Bookmarked
Mammals didn’t walk upright until late—here’s what fossils reveal For over a century, scientists have puzzled over a fundamental mystery in our evolutionary history: how did mammals go from sprawling like lizards to striding like cats and dogs? This transition — from a sprawled stance (like a lizard) to an upright (parasagittal) posture — marked a pivotal moment in mammal evolution. While the earliest […] Written by Admin June 30, 2025June 30, 2025 Saving Bookmark this article Bookmarked
A coordinated kinase and phosphatase network regulates Stu2 recruitment to yeast kinetochores Cells coordinate diverse events at anaphase onset, including separase activation, cohesin cleavage, chromosome separation, and spindle reorganization. Regulation of the XMAP215 family member and microtubule polymerase, Stu2, at the metaphase-anaphase transition determines a redistribution from kinetochores to spindle microtubules. We show that cells modulate Stu2 kinetochore-microtubule localization by Polo-like kinase1/Cdc5-mediated phosphorylation of T866, near the […] Written by Admin June 29, 2025June 29, 2025 Saving Bookmark this article Bookmarked
‘Crunch time’ on climate He said: “I certainly tend to be an optimistic person but if you do look at this year’s annual update, things are all moving in the wrong direction.” “They’re not only moving in the wrong direction, we’re seeing some unprecedented changes.” Reflecting on the IPCC reports, he said: “What we had hope to see by […] Written by brendan June 29, 2025June 29, 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