Pharmaceuticals and Drug Development KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–Sep. 3, 2024– KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat… Written by Admin September 17, 2024September 17, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Discovery Park Ventures expands fund to £3m to invest in more innovative science and technology start-ups Sandwich, Kent, UK, 4th December 2023 – Discovery Park Ventures (DPV) announces the expansion of its early-stage life science fund from £1m to £3m, in order to capitalise on exciting investment opportunities and support its existing portfolio. The fund’s investors have committed an additional £2m, which will also enable the fund to take larger stakes […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom September 5, 2024September 5, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Regeneron Provides Update on Biologics License Application for Linvoseltamab TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application… Written by Admin August 24, 2024August 24, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Automated Multiorgan CT Can Predict Diabetes, Other Conditions Medically reviewed by Drugs.com. By Elana Gotkine HealthDay Reporter FRIDAY, Aug. 16, 2024 — Automated multiorgan computed tomography (CT), including visceral fat, can predict diabetes and associated cardiometabolic conditions, according to a study published online Aug. 6 in Radiology. Yoosoo Chang, M.D., Ph.D., from Sungkyunkwan University School of Medicine in Seoul, South Korea, and colleagues […] Written by Admin August 18, 2024August 18, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development New protein linked to early-onset dementia identified Scientists have identified abnormal aggregates of a protein called TAF15 in the brains of individuals with early-onset dementia, known as frontotemporal dementia, where the cause was not previously known. Most neurodegenerative diseases, including dementias, involve proteins aggregating into filaments called amyloids. In most of these diseases, researchers have identified the proteins that aggregate, allowing them […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom August 12, 2024August 12, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Grants Accelerated Approval for Tecelra (afamitresgene autoleucel) Cell Therapy for the Treatment of Synovial Sarcoma FDA Grants Accelerated Approval for Tecelra (afamitresgene autoleucel) Cell Therapy for the Treatment of Synovial Sarcoma PHILADELPHIA & OXFORD, England–(BUSINESS WIRE) August 01, 2024 — Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced U.S. Food and Drug Administration (FDA) accelerated approval of […] Written by Admin August 6, 2024August 6, 2024 Saving Bookmark this article Bookmarked
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
Scientists capture flu viruses surfing into human cells in real time Fever, aching limbs and a runny nose — as winter returns, so too does the flu. The disease is triggered by influenza viruses, which enter our body through droplets and then infect vulnerable cells. A research team from Switzerland and Japan has taken an exceptionally close look at how this virus behaves. Using a microscopy […] Written by Admin December 6, 2025December 6, 2025 Saving Bookmark this article Bookmarked
FDA slaps hold on Denali's plans for phase 1 rare disease trial The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Scientists capture flu viruses surfing into human cells in real time Fever, aching limbs and a runny nose — as winter returns, so too does the flu. The disease is triggered by influenza viruses, which enter our body through droplets and then infect vulnerable cells. A research team from Switzerland and Japan has taken an exceptionally close look at how this virus behaves. Using a microscopy […] Written by Admin December 6, 2025December 6, 2025 Saving Bookmark this article Bookmarked
FDA slaps hold on Denali's plans for phase 1 rare disease trial The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Hornet-eating frog shows remarkable venom resistance A frog with an unexpectedly strong resistance to venom has been identified, and it routinely eats hornets despite the insects’ dangerous stingers. Researchers believe this species may become a useful model organism for exploring how animals develop tolerance to venom. For many people, even glimpsing a hornet’s stinger is enough to cause alarm. Yet certain […] Written by Admin December 5, 2025December 5, 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