PharmaFocus Today – Page 225 – media

Hengrui Pharmaceuticals’s CD79b ADC Innovative Drug SHR-A1912 Receives U.S. FDA Fast Track Eligibility Recognition

Recently, Hengrui Pharmaceuticals’s self-developed CD79b antibody-drug-conjugate (ADC) innovation SHR-A1912 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphomas (R/R DLLC) that have received at least 2 lines of therapy in the past. SHR-A1912 was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has previously received at least 2 lines of therapy. This is also the 2nd product of the Company to be granted Fast Track status by the FDA. In January this year, the Company announced that its self-developed HER3 ADC innovative drug SHR-A2009 for injection was granted Fast Track status by the FDA for the treatment of metastatic non-small-cell lung cancer (“NSCLC”) with EGFR mutation that has progressed after third-generation EGFR tyrosine kinase inhibitor and ...
- Source: drugdu
- 222
- February 26, 2024
China’s First Domestic Dual-Target Gout Inhibitor (THDBH151 Tablet) Reaches Primary Endpoint in Phase I Clinical Trial

Dong Bao Zi Xing Ltd., a wholly-owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company”), has recently completed a pivotal Phase I clinical trial of a dual-target XO/URAT1 inhibitor for gout (THDBH151 tablets) and obtained a clinical trial summary report, which shows that the study results have reached the primary endpoint. The results of the study showed that the primary endpoints were met. The results of the “Phase I Clinical Study of the Safety, Tolerability, Pharmacogenetics/Pharmacodynamics and Effect of Food of THDBH151 Tablets in Healthy Adult Subjects with Single and Multiple Doses” conducted by the Company showed that the product was safe and well-tolerated in healthy Chinese adult subjects, with overall adverse event rates similar to or slightly lower than those of placebo, and that all adverse events were similar to or lower than those of placebo. The overall adverse event rate was similar to or slightly lower than ...
- Source: drugdu
- 182
- February 26, 2024
Novel Immunoassays Enable Early Diagnosis of Antiphospholipid Syndrome

Antiphospholipid syndrome (APS) is an autoimmune disorder that typically presents as venous or arterial thrombosis and/or pregnancy loss. Diagnosing APS can be difficult as its symptoms often resemble those of other diseases. Prompt diagnosis is essential to avoid complications, unnecessary medical procedures, and escalating healthcare costs. Now, a new pair of reagents can enable early diagnosis of APS, one of the hard-to-diagnose autoimmune diseases. Werfen’s (Barcelona, Spain) Aptiva APS Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents are immunoassays that utilize Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They serve as a diagnostic aid for both primary and secondary APS, in conjunction with other laboratory findings. The Aptiva system is a fully automated, multi-analyte system, representing the latest advancement in high throughput analyzers for autoimmunity and immunology laboratories. Utilizing ...
- Source: drugdu
- 143
- February 24, 2024
Treadwell Therapeutic’s Novel Acute Myeloid Leukemia Treatment Granted FDA Orphan Drug Designation

Davy James Ocifisertib is a first-in-class, novel PLK4 inhibitor that has demonstrated significant activity as a monotherapy in both solid and liquid tumors. Image credit: Arif Biswas | stock.adobe.com Treadwell Therapeutics’s ocifisertib (CFI-400945) has been granted orphan drug designation by the FDA for the treatment of acute myeloid leukemia (AML).1 The first-in-class, novel PLK4 inhibitor has been found to regulate centriole duplication in patients with AML. “The FDA’s decision to grant orphan drug designation, along with the previous FDA Fast Track designation for ocifisertib, underscores [our] dedication to addressing this patient population with few treatment options. Patients with relapsed and/or refractory AML—in particular TP53-mutated disease—suffer poor overall survival and represents a high unmet clinical need,” said Roger Sidhu, MD, acting CEO of Treadwell Therapeutics, in a press release. The PLK4 enzyme is typically overexpressed in cancer cells and has been associated with adverse survival outcomes. Inhibiting PLK4 has been found ...
- Source: drugdu
- 145
- February 24, 2024
Novavax and Gavi Settle Dispute Over Covid Vaccines Pact, Avoiding Arbitration

By settling now and agreeing to deferred payments over the next five years, Novavax avoids the risk of being responsible for a much bigger payout all at once. The arbitration hearing over the disputed vaccine purchase agreement with Gavi was scheduled for this summer. By FRANK VINLUAN Novavax isn’t in a good financial position to be refunding money to customers, having gone through a cost-saving restructuring amid flagging sales of the Covid-19 vaccine that is its only revenue-generating product. But arbitration is uncertain, so rather than roll the dice and risk a huge payout if the dispute resolution does not go its way, the company has agreed to pay Gavi, the Vaccine Alliance, as much as $475 million over the next five years to settle a squabble over a $700 million purchase agreement. Like other Covid-19 vaccine makers, Gaithersburg, Maryland-based Novavax supplies its vaccine under advance purchase agreements. Government bodies ...
- Source: drugdu
- 148
- February 24, 2024
New Analysis Method Detects Pathogens in Blood Faster and More

Globally, an alarming one in every five deaths is attributed to complications related to sepsis, with children accounting for 41% of these fatalities. The urgency in detecting sepsis is paramount since the risk of mortality increases by 4% for each hour the infection remains undiagnosed or treated incorrectly. Common practice involves administering antibiotics to sepsis patients while waiting for blood culture results, which can contribute to antibiotic resistance. Ineffectively treating sepsis can be detrimental, as up to 30% of patients receive incorrect treatments, further elevating their risk of death. The critical nature of timely and accurate diagnosis in sepsis cases is underscored by the fact that the mortality risk escalates by 4% every hour the infection is not properly identified or treated. Now, a new analysis technique offers quicker and more precise pathogen detection in blood samples compared to traditional blood cultures, which are the standard in infection diagnosis. The ...
- Source: drugdu
- 180
- February 24, 2024
Ultra-Sensitive Blood Test Reflects Brain Damage and Predicts Functional Outcomes after Ischemic Stroke

Acute ischemic stroke, which is the most common type of stroke, occurs due to a lack of oxygen in the brain caused by a blood clot. Currently, there are no blood-based biomarkers that can accurately reflect the acute neuronal damage following a stroke or predict the clinical outcomes for stroke patients. Now, a new study has demonstrated that an ultra-sensitive blood test can reflect brain damage and also predict functional outcomes after acute ischemic stroke. Brain-derived tau (BD-tau), a protein indicative of neuronal breakdown in the central nervous system, particularly in Alzheimer’s disease, has been the focus of recent research. Last year, a team from the University of Gothenburg (Gothenburg, Sweden) developed a novel blood test to measure BD-tau levels. This breakthrough represents a significant step towards creating a tool for tracking and monitoring Alzheimer’s disease progression. In their latest research, this team explored whether BD-tau could also serve as ...
- Source: drugdu
- 202
- February 23, 2024
Gold-Enhanced Nanopore Sensors Detect Ovarian Cancer Biomarkers in Urine Samples

The key to defeating cancer lies in its early and accurate diagnosis. Clinical data underscores this, revealing a significant 50-75% increase in the five-year survival rate when cancers are identified in their initial stages. This is true for various types of cancer, including ovarian cancer, which is notoriously challenging to diagnose. Mass spectrometry has been instrumental in discovering thousands of peptides in the urine of ovarian cancer patients, indicating their potential as biomarkers for the disease. However, the application of mass spectrometry in clinical settings is limited, prompting the need for alternative methods to detect these peptides. Now, a new study has found a novel technique to be effective in identifying specific biomarkers found in the urine of ovarian cancer patients, a development that could eventually aid doctors in diagnosing the disease more accurately. Researchers from Virginia Commonwealth University (VCU, Richmond, VA, USA) employed a combination of gold nanoparticles and ...
- Source: drugdu
- 341
- February 23, 2024
Regeneron’s Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

Davy James The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024. Image credit: ibreakstock | stock.adobe.com The FDA has granted Priority Review to Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies. The bispecific antibody was developed to bridge B-cell maturation antigen on multiple myeloma cells that have CD3-expressing T cells, which subsequently activates T cells to prompt the elimination of cancer cells. The FDA assigned the BLA with a Prescription Drug User Fee Act of August 22, 2024. An estimated 35,000 US residents will be diagnosed with multiple myeloma on an annual basis. Although research efforts have achieved significant progress in treating multiple myeloma, the disease is not yet curable. Current treatments have been able ...
- Source: drugdu
- 173
- February 23, 2024
Bavarian Nordic Hones Infectious Disease Focus by Dropping Cancer Vaccine R&D

Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program. By FRANK VINLUAN The mpox outbreak is a memory, but Bavarian Nordic, maker of the only FDA-approved vaccine for the pathogen behind this viral infection, turned skyrocketing demand for its product into record revenue. With that growth comes a need to focus, and the pure-play vaccines company is getting out of the business of developing vaccines for cancer. Bavarian Nordic’s lone cancer vaccine candidate, TAEK-VAC, had reached Phase 1 testing as a potential treatment for chordoma or HER2-positive breast cancer. But this program had also reached the point where further investment is needed, and Bavarian Nordic decided it needs to focus its R&D efforts on infectious disease, the Denmark-based company said Wednesday in its announcement of preliminary 2023 financial ...
- Source: drugdu
- 239
- February 23, 2024

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