Pharma News

The early stages of embryonic development contain many of life’s mysteries. Unlocking these mysteries can help us better understand early development and birth defects, and help develop new regenerative medicine treatments.

Researchers based at the Australian Regenerative Medicine Institute (ARMI) at Monash University have characterised a critical time in mammalian embryonic development using powerful and innovative imaging techniques, with their work published in Nature Communications.

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.

Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with :
heart failure or
type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Every year, hundreds of thousands of people in West Africa become infected with Lassa virus, which can cause Lassa fever and lead to severe illness, long-term side effects or death. There are currently no widely approved treatments or vaccines for the disease. Now, scientists at Scripps Research have determined the structure of the critical protein complex that lets Lassa virus infect human cells.

New research from Oregon Health & Science University is helping explain why at least five people have become HIV-free after receiving a stem cell transplant. The study’s insights may bring scientists closer to developing what they hope will become a widespread cure for the virus that causes AIDS, which has infected about 38 million people worldwide.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.

The Drug Control Administration (DCA) has stopped 11 pharmaceutical manufacturing firms located in the pharmaceutical hub of Baddi, Barotiwala, Nalagarh, Sirmaur and Kangra districts after significant observations were detected in its functioning during risk-based inspections conducted recently.

State Drugs Controller Navneet Marwaha said, "In the last two months, 29 firms were inspected in the second phase of the joint inspection by the state DCA and the Central Drugs Standard Control Organisation."

The U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.

Johnson & Johnson has settled its lawsuit over Amgen's proposed biosimilar version of J&J's top-selling treatment Stelara for psoriasis and other autoimmune conditions, according to a filing in Delaware federal court.

Amgen said in a statement on Tuesday that the settlement terms are confidential, but it will allow the company to sell its biosimilar of Stelara "no later than January 1st, 2025."