Don Tracy, Associate Editor Action marks the first FDA-approved blood screening test for malaria. Roche announced that the FDA has officially approved the Cobas Malaria test, focused on inspecting blood donors for malaria, aiming to enhance the safety of blood supply. The test, which screens blood samples for five species of Plasmodium parasites, is the first of its kind approved for this purpose and aims to reduce the risk of malaria transmission through transfusions. Roche stated that it expects the test to be available in the United States at some point during the second quarter of this year.1 “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for ...
Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. By FRANK VINLUANDuchenne muscular dystrophy has several approved drugs, including a gene therapy that provides children who have the rare, inherited muscle-wasting disease the option of a one-time treatment. But each of these therapies only treats certain defined patient groups. While corticosteroids can reach more Duchenne patients, they introduce many side effects. The FDA just approved the first nonsteroidal Duchenne drug. The late Thursday approval of Italfarmaco drug givinostat covers patients age 6 and older and spans all genetic variants that drive the inherited disease. The twice-daily oral suspension will be marketed under the brand name Duvyzat. In an email, Italfarmaco said Duvyzat’s price has not yet been set. The Milan, Italy-based ...
Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
Davy James Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg. The FDA has approved an expanded indication for Johnson & Johnson’s Edurant PED (rilpivirine) in combination with other antiretroviral therapies (ART) to treat HIV-1 in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) aged at least 2 years and weighing between 14 kg and 25 kg.1 Edurant is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor previously approved in combination with ART in treatment-naïve patients 12 years of age and older who weigh at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. “Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their ...
Drugdu.com expert’s response: FDA food-grade certification typically refers to the certification or approval by the U.S. Food and Drug Administration (FDA) for food-related products. This certification generally includes two types: 1.Food Additive Approval: FDA’s certification of food additives involves the FDA approving a substance for use in food processing to improve the quality, freshness, taste, or other characteristics of food. These food additives may include preservatives, sweeteners, colorants, thickeners, etc. Once FDA approval is obtained, these additives can be legally used in food processing. 2.Food Contact Material Certification: FDA’s certification of food contact materials refers to the FDA approving a material for use in the manufacture or processing of food or potable water. These materials may include food packaging, containers, manufacturing equipment, etc., used to protect food from contamination or pollution. FDA-certified food contact materials typically comply with FDA regulations, ensuring that they do not pose a hazard to food ...
Davy James Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies. The FDA has approved Idorsia Ltd’s Tryvio (aprocitentan) to reduce hypertension in combination with other antihypertensive drugs in adults whose blood pressure is not adequately controlled by other therapies. Tryvio is an endothelin receptor antagonist that interferes with the binding of endothelin (ET)-1 to ETA and ETB receptors.1 “Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies. This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events,” Jean-Paul Clozel, MD, CEO of Idorsia said in a press release. “In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a ...
Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
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