Pharma News

The U.S. Food and Drug Administration has approved Xenpozyme for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients.

Xenpozyme is the first therapy indicated specifically for the treatment of ASMD (acid sphingomyelinase deficiency), and is currently the only approved treatment for this disease.

From 2023, there will be no free COVID-19 vaccines for Americans. The US federal government may opt for full commercialization of COVID-19 vaccines and other oral antiviral medicines.

The US federal government has played the central coordinating role in buying, distributing, and ensuring equitable access to COVID-19 vaccines, therapeutics, and tests.

Aspen Pharmacare has concluded a ten-year agreement with Serum Institute of India, the world’s largest vaccine producer, for Aspen SA operations to manufacture, market and distribute four Aspen-branded routine vaccines in Africa, excluding certain markets due to the Serum Institute having grated prior rights to third parties.

U.S. Food and Drug Administration (USFDA) issues Form 483s to three sites of Biocon Biologics at India and Malaysia. USFDA issues 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.

USFDA conducted three on-site inspections of Biocon Biologics seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.

Preeclampsia is a condition that affects the placenta during pregnancy and is dangerous for both the fetus and the mother. Scientists from the Institut Pasteur, Inserm and the CNRS have proposed a new therapy, tested in two rodent models, that corrects the defects identified in placental cells, and restores placental and fetal weight. The treatment successfully lowers blood pressure in the mother and resolves the characteristic preeclampsia symptoms of excess protein in urine and cardiovascular abnormalities.

Are would-be parents carrying a genetic risk of serious illnesses that they could potentially pass on to their children? In the USA, doctors recommend that couples have genetic screening before trying to conceive. Researchers at the University of Zurich have now shown that a maximal variant of this test detects the risk in 44 percent of couples who are related by blood, and in just 5 percent of other couples. Non-hereditary newly acquired mutations are a major reason for the reduced detection rate in the latter.

Young people living with a genetic alteration that increases the risk of psychiatric disorders have markedly different brain activity during sleep, a study led by researchers from the Universities of Bristol and Cardiff published today in eLife shows.

The brain activity patterns during sleep shed light on the neurobiology behind a genetic condition called 22q11.2 Deletion Syndrome (22q11.2DS) and could be used as a biomarker to detect the onset of neuropsychiatric disorders in people with 22q11.2DS.

Soon India will get its first made in India vaccine against cervical cancer which is developed by Serum Institute of India (SII) and the Department of Biotechnology (DBT). The daid vaccine is Quadrivalent Human Papillomavirus vaccine (qHPV).

Zydus Lifesciences initiates Phase IV clinical trial for Desidustat in patients with Chronic Kidney Disease (CKD) induced anemia.

Desidustat sold under a brand name Oxemia which is a prescription drug approved in India for patients with Chronic Kidney Disease (CKD) induced anemia, and can be taken only under the advice and guidance of a Nephrologist or an internal medicine specialist.