Search Results for “EC” – Page 289 – media

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
- 87
- 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
- 87
- 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
- 90
- February 24, 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
- 130
- February 23, 2024
Innovent Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA

ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
- Source: drugdu
- 174
- February 23, 2024
Multi-agency report highlights importance of reducing antibiotic use

Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and AMR in Europe. For the first time as part of this project, the three agencies analysed trends of antimicrobial consumption and AMR in Escherichia coli (E. coli) from both humans and food-producing animals. They also looked into how these trends were changing in humans and food-producing animals during 2014 – 2021. For example, during this timeframe, antibiotic consumption in food-producing animals decreased by 44%. The analysis performed by the three Agencies found that E. coli bacteria in both animals and humans are becoming less resistant to antibiotics as the overall antibiotic consumption is reduced. This shows that the concerning trends in antibiotic resistance can be reversed with the right actions and policies. The report also shows that, in humans, the ...
- Source: drugdu
- 78
- February 23, 2024
Olymvax’s Quadrivalent Influenza Virus Vaccine (Split Virion) Clinical Trials Accepted

Recently, the State Drug Administration announced on its website that it agreed to accept Olymvax’s application to conduct clinical trials of quadrivalent influenza virus cracking vaccine, marking new progress in Olymvax’s first product pipeline of virus-based vaccines. Influenza (also known as influenza) is an acute respiratory infection caused by influenza viruses, spread by respiratory droplets and contact, and the population is generally susceptible. Influenza poses a significant burden on global public health, and vaccination is the most effective way to reduce this burden. Vaccination with quadrivalent influenza virus lysate vaccine can stimulate the body to produce anti-influenza virus immunity, and is used to prevent influenza caused by vaccine-associated types of influenza viruses. Currently, most of the influenza vaccines available in China are based on chicken embryos. The influenza vaccine developed by Olymvax is based on MDCK cell mass culture technology, which can realize higher production yield, more stable product quality ...
- Source: drugdu
- 74
- February 23, 2024
Navigate Pharma Trade with Ease – Essential Websites & Tools for Success

The pharmaceutical trade industry is fiercely competitive, requiring constant updates on the latest market information and technological tools for better business expansion. Today, we’ll introduce some indispensable websites and practical tools to help you conduct your business more efficiently. 1.Global Trade Alert (https://www.globaltradealert.org/) Global Trade Alert is a website offering real-time tracking of global trade data, policy, and regulatory changes, helping trade professionals understand each country’s import and export policies for pharmaceutical products, market dynamics, and potential risks. 2.gov (https://www.export.gov/) Export.gov, the official website of the U.S. International Trade Administration, provides vast information on exporting, including market intelligence, export planning, and trade policies. The pharmaceutical product export guide helps trade professionals comprehend the U.S. pharmaceutical market overview and export regulations. 3.FDA (https://www.fda.gov/) The FDA, the official website of the U.S. Food and Drug Administration, provides regulations, standards, and registration requirements for various pharmaceutical products, enabling trade professionals to ensure their ...
- Source: drugdu
- 216
- February 22, 2024
WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy

Don Tracy, Associate Editor Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer. WuXi Advanced Therapies announced that it has officially received approval from the FDA to begin analytical testing and manufacturing of Amtagvi (lifileucel), Iovance Biotherapeutics’ recently approved treatment for advanced melanoma. According to a company press release, the treatment is a tumor-derived autologous T cell immunotherapy, specifically developed for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This also marks the first one-time, individualized T cell therapy to be approved by the FDA for any solid tumor cancer. “We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from ...
- Source: drugdu
- 161
- February 22, 2024
Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. By FRANK VINLUAN Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday. The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the ...
- Source: drugdu
- 155
- February 22, 2024

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