Archives: 2023-04-26

FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene

Action FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Qalsody is an antisense oligonucleotide that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. The approval was based on a reduction in plasma neurofilament light (NfL), a blood-based

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FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is intended for use in adults and pediatric patients 12 years and older

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More than 1 million lives saved in Europe by COVID-19 vaccines since the end of 2020: research presented at European Congress of Clinical Microbiology & Infectious Diseases

COVID-19 vaccination directly saved at least 1,004,927 lives across Europe between December 2020 and March 2023, according to new research being presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (15-18 April). The new estimates by WHO/Europe and presented at the conference by Dr Margaux Meslé,  Epidemiologist at

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Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients

A nonstatin therapy approved almost 3 years ago to treat low-density lipoprotein (LDL) cholesterol also cuts the risk of major cardiovascular events, especially heart attacks, according to data presented. Bempedoic acid, approved in February 2020 as Nexletol (Esperion), reduced by 13% the risk of a 4-part composite end point of major adverse cardiovascular events (MACE),

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New therapy harnesses patients’ blood cells to fight tumors

Noninvasive approach is fast, cost-effective and could be used to treat a variety of cancers doptive cell therapy (ACT) has become a promising immunotherapy tool to help treat advanced melanoma. The therapy, which harnesses immune cells collected from the patient’s own tumors, could provide a new treatment option to cancer patients, potentially bypassing radiation therapies

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Severe Covid-19: new anti-C5a antibody approved by FDA

A new antibody drug by pharmaceutical company inflaRx received FDA emergency use authorization to treat critically ill Covid-19 patients. One of the greatest hurdles for monoclonal antibody development during the Covid-19 pandemic is the ongoing mutation of the SARS-CoV-2 virus. Most antibodies introduced throughout the pandemic targeted the virus spike protein, which mutates significantly with every emerging

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