Pharma News

Pfizer Inc and BioNTech SE announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.

Union Minister of State (Independent Charge) Science & Technology, Dr Jitendra Singh said, India will make significant investment in R&D to develop a roadmap for design and delivery of vaccine development for future pandemic.

Scientists have identified a drug that can be repurposed to prevent COVID-19 in research involving a unique mix of ‘mini-organs’, donor organs, animal studies and patients.

Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI1.

The Ministry of Health and Family welfare amended the New Drugs and Clinical Trials Rules, 2019 in consultation with the Drugs Technical Advisory Board, DTAB, and specified non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug.

Scientists at Scripps Research have reported success in initial tests of a new, nanotech-based strategy against autoimmune diseases.

The scientists, who reported their results on November 23, 2022, in the journal ACS Nano, engineered cell-like “nanoparticles” that target only the immune cells driving an autoimmune reaction, leaving the rest of the immune system intact and healthy. The nanoparticles greatly delayed, and in some animals even prevented, severe disease in a mouse model of arthritis.

Adding a daily ounce of peanuts or about a teaspoon of herbs and spices to your diet may affect the composition of gut bacteria, an indicator of overall health, according to new research from Penn State. In two separate studies, nutritional scientists studied the effects of small changes to the average American diet and found improvements to the gut microbiome.

While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being pursued by researchers at Scripps Research, IAVI, Fred Hutchinson Cancer Center (Fred Hutch) and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) shows new promise, according to data from a first-in-human clinical trial.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.