Clinical Alzheimer’s drug discovery foundation’s statement on FDA advisory committee’s endorsement of donanemab NEW YORK, June 10, 2024. Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. If approved, donanemab would become the second disease-modifying drug for Alzheimer’s to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer’s […] Written by Admin June 11, 2024June 11, 2024 Saving Bookmark this article Bookmarked
Clinical Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials DURHAM, N.C. and BEIJING, June 7, 2024. Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on […] Written by Admin June 9, 2024June 9, 2024 Saving Bookmark this article Bookmarked
Clinical AbbVie Announces Positive Topline Results from Phase 2 Trial Evaluating Elahere for High Folate Receptor-Alpha Expressing Platinum-Sensitive Ovarian Cancer NORTH CHICAGO, Ill., June 6, 2024. AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%). […] Written by Admin June 7, 2024June 7, 2024 Saving Bookmark this article Bookmarked
Clinical Surrozen Initiates Dosing of First Patient in Phase 1b Clinical Trial of SZN-043 for Severe Alcohol-Associated Hepatitis SOUTH SAN FRANSCISO, Calif., June 04, 2024. Surrozen, Inc. (“Surrozen” or the “Company”), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced that the first patient has been dosed in its Phase 1b clinical trial for SZN-043 in patients with severe alcohol-associated hepatitis. The Phase 1b […] Written by Admin June 5, 2024June 5, 2024 Saving Bookmark this article Bookmarked
Clinical Novartis Phase III Data Confirm Sustained Efficacy and Long-Term Safety of Oral Remibrutinib in Chronic Spontaneous Urticaria Basel, May 31, 2024 – Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU)1. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early, which was sustained up to Week 52, […] Written by Admin June 3, 2024June 3, 2024 Saving Bookmark this article Bookmarked
Clinical Avirmax Biopharma Inc. Receives IND Approval for Phase I/IIa Trial to Treat Wet AMD including PCV HAYWARD, Calif., May 30, 2024. Avirmax Biopharma, Inc., a leading innovator in genetic medicines, is pleased to announce that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/IIa clinical trial for its gene therapy treatment targeting wet Age-related Macular Degeneration (AMD) including Polypoidal […] Written by Admin May 31, 2024May 31, 2024 Saving Bookmark this article Bookmarked
Clinical Neuren Phase 2 trial shows significant improvements in Pitt Hopkins syndrome MELBOURNE, Australia, May 27, 2024. Neuren Pharmaceuticals (ASX: NEU) today announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core […] Written by Admin May 29, 2024May 29, 2024 Saving Bookmark this article Bookmarked
Clinical HI-Bio Announces Positive Results from Phase 2 Study of Felzartamab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients SOUTH SAN FRANCISCO, Calif., May 25, 2024. Human Immunology Biosciences (HI-Bio), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced positive results from a Phase 2 investigator-sponsored clinical trial of felzartamab for late antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab is an investigational monoclonal antibody designed to […] Written by Admin May 27, 2024May 27, 2024 Saving Bookmark this article Bookmarked
Clinical Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of Afuresertib PLUS LAE001 for the Treatment of Prostate Cancer SHANGHAI and WARREN, N.J., May 23, 2024. Laekna, Inc., a science-driven, clinical-stage biotechnology company, announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) (“LAE201”)in patients with metastatic castration-resistant prostate cancer […] Written by Admin May 25, 2024May 25, 2024 Saving Bookmark this article Bookmarked
Clinical New Results From Rilzabrutinib Phase 2 Study Show Potential to be First Advanced Oral Treatment for Moderate-to-Severe Asthma Paris, May 22, 2024. Encouraging results from a phase 2 study showed that treatment with oral rilzabrutinib at both high dose and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. These results were presented today […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked
New Arabidopsis BIK1 Alleles Confirm Immunity Role In a groundbreaking study poised to redefine our understanding of plant immunity, researchers have unveiled novel insights into the pivotal roles of the receptor-like cytoplasmic kinases BIK1 and PBL1 in Arabidopsis. These kinases, previously studied primarily through single transfer DNA (T-DNA) insertional mutant alleles, are reaffirmed as central players in the plant’s pattern-triggered immunity (PTI) […] Written by Bioengineer January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
Climate Action Costs More in the Global South. Here’s Why. – State of the Planet Clean energy technologies have become more affordable around the world. Yet for many countries in the Global South, the cost of transitioning to a low-carbon economy remains disproportionately high. But not because the equipment is more expensive: in fact, solar and wind components are often imported at comparable prices around the world, as global manufacturing scale and […] Written by Guest January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
New Arabidopsis BIK1 Alleles Confirm Immunity Role In a groundbreaking study poised to redefine our understanding of plant immunity, researchers have unveiled novel insights into the pivotal roles of the receptor-like cytoplasmic kinases BIK1 and PBL1 in Arabidopsis. These kinases, previously studied primarily through single transfer DNA (T-DNA) insertional mutant alleles, are reaffirmed as central players in the plant’s pattern-triggered immunity (PTI) […] Written by Bioengineer January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
Climate Action Costs More in the Global South. Here’s Why. – State of the Planet Clean energy technologies have become more affordable around the world. Yet for many countries in the Global South, the cost of transitioning to a low-carbon economy remains disproportionately high. But not because the equipment is more expensive: in fact, solar and wind components are often imported at comparable prices around the world, as global manufacturing scale and […] Written by Guest January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism REDWOOD CITY, Calif.–(BUSINESS WIRE)–Dec. 31, 2025– Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and… Written by Admin January 7, 2026January 7, 2026 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