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U.S. FDA approves Pfizer's BEQVEZ™ (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with Hemophilia B
on April 26, 2024 at 8:00 am
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. […]
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AskBio receives FDA Fast Track Designation for AB-1002 investigational gene therapy program in congestive heart failure
on April 25, 2024 at 8:00 am
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program. AB-1002 is an investigational one-time gene therapy that is administered to the heart with the intention of helping to promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase 1. […]
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Researchers publish final results of key clinical trial for gene therapy for sickle cell disease
on April 24, 2024 at 8:00 am
In a landmark study, an international consortium led by researchers at Children's Hospital of Philadelphia (CHOP) published the final results of a key clinical trial of the gene therapy CASGEVY (exagamglogene autotemcel) for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises (VOCs). The study found that 96.7% of patients in the study did not have any vaso-occlusive crises (VOCs) - a blockage that results in lack of oxygen and painful episodes - for at least one year, and 100% were able to remain hospitalization-free for the same length of time. […]
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Optimal timing maximises Paxlovid benefits for treating COVID-19
on April 23, 2024 at 8:00 am
Researchers have described the optimal timing for COVID-19 patients to take the antiviral, Paxlovid, to get the most benefit from the treatment, according to a study published April 16 in eLife. The findings suggest that taking Paxlovid three to five days after COVID-19 symptoms emerge may maximise the drug's ability to reduce viral loads, minimise viral spread and reduce viral rebound. […]
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European Commission approves Pfizer's EMBLAVEO® for patients with multidrug-resistant infections and limited treatment options
on April 22, 2024 at 8:00 am
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. […]
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