Pharma News

Sweat is more than just a sign of a good workout. It holds vital information about our health, providing clues to dehydration, fatigue, blood sugar levels and even serious conditions such as cystic fibrosis, diabetes and heart failure. Researchers at the University of Hawaiʻi at Mānoa College of Engineering have taken a giant leap forward in sweat analysis with an innovative 3D-printed wearable sweat sensor called the “sweatainer.”

Zydus Life Sciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram (USRLD: Carafate Tablets, 1 gram).

Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).

AstraZeneca Pharma India has received a permission in Form CT-20 to Import for sale and distribution of Trastuzumab deruxtecan (Enhertu) 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India.

Cancer immunotherapy has transformed the treatment of many types of cancer. Yet, for reasons that remain poorly understood, not all patients get the same benefit from these powerful therapies.

Gene-editing therapy aimed at two targets – HIV-1, the virus that causes AIDS, and CCR5, the co-receptor that helps the virus get into cells – can effectively eliminate HIV infection, new research from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) shows. The study, published online in the journal The Proceedings of the National Academy of Sciences (PNAS), is the first to combine a dual gene-editing strategy with antiretroviral drugs to cure animals of HIV-1.

FDA halts clinical trials of Deuruxolitinib due to the potential for thrombotic events seen in subjects. FDA has placed the IND on partial clinical hold and are requiring that subjects currently on studies to discontinue the dose.

It has been noted by the FDA that pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies of Deuruxolitinib.

Astellas Pharma Inc and Pfizer Inc announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

What the human genome is lacking compared with the genomes of other primates might have been as crucial to the development of humankind as what has been added during our evolutionary history, according to a new study led by researchers at Yale and the Broad Institute of MIT and Harvard.

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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 biomarker of axonal (nerve) injury and neurodegeneration.