Pharmaceuticals and Drug Development Pacira Announces FDA Approval of Expanded Exparel Label to Include Two Additional Nerve Block Indications Exparel is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies — New indications for use as an adductor canal block and sciatic nerve block in the popliteal fossa will significantly extend reach within more than 3 million lower extremity procedures TAMPA, […] Written by Admin November 15, 2023November 15, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease Treatment for: Anemia Associated with Chronic Renal Failure Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney […] Written by Admin November 14, 2023November 14, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Earlier Onset of A-Fib Linked to Risk of Developing All-Cause Dementia Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 10, 2023. By Elana Gotkine HealthDay Reporter THURSDAY, Nov. 9, 2023 — Earlier onset of atrial fibrillation (AF) is associated with increased risk of developing all-cause dementia, vascular dementia (VD), and Alzheimer disease (AD), according to a study published online Nov. 8 in JAMA Network […] Written by Carmen Pope November 13, 2023November 13, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development First wireless map of worm’s nervous system revealed This huge step forward in understanding how neurons communicate through extremely short proteins called neuropeptides will help scientists understand how our emotions and mental states are controlled, as well as widespread neuropsychiatric conditions like eating disorders, OCD and PSTD. The map, which details 31,479 neuropeptide interactions between the worm’s 302 neurons, shows where each neuropeptide, […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom November 12, 2023November 12, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved Ixchiq®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease […] Written by Admin November 11, 2023November 11, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome Treatment for: WHIM Syndrome X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) –X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the United States Food and Drug […] Written by Admin November 10, 2023November 10, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development One-Day Induction of XR Buprenorphine Feasible for Fentanyl Use in OUD Medically reviewed by Drugs.com. By Elana Gotkine HealthDay Reporter WEDNESDAY, Nov. 8, 2023 — For individuals with opioid use disorder (OUD) using fentanyl, a one-day induction of extended‐release buprenorphine is a feasible treatment approach, according to a study published online Nov. 8 in the American Journal on Addiction. John J. Mariani, M.D., from the New […] Written by Admin November 9, 2023November 9, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Cancer Research UK and the KWF Dutch Cancer Society enter partnership to bring multiple drugs into clinical development Under the partnership, KWF intends to provide funding to enable the development of select early phase clinical programmes* through Cancer Research UK’s Centre for Drug Development (CDD). Cancer Research UK’s CDD will be utilising its 30 years of experience in ushering first-in-class and best-in-class therapeutics through the clinic to sponsor and manage KWF-supported trials as […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom November 8, 2023November 8, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus November 06, 2023, Ahmedabad, India — Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvimet (Sitagliptin and Metformin hydrochloride) […] Written by Admin November 6, 2023November 6, 2023 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA Generic name: apomorphineTreatment for: Hypomobility in Parkinson’s Disease Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the […] Written by Admin November 5, 2023November 5, 2023 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
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
Urban environments promote adaptation to multiple stressors Animal populations from urban areas show significantly higher resilience to stressful environmental conditions. This was found by an international team of researchers led by Dr Elizabeta Briski from the GEOMAR Helmholtz Centre for Ocean Research Kiel, Germany. The mussel and crustacean species studied were able to adapt to disturbed environments, making them more resistant to […] Written by Admin February 20, 2025February 20, 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