OMEN Pharma

Samsung Bioepis Receives FDA Approval for Pyzchiva, a Biosimilar to Stelara, for Multiple Inflammatory Conditions Samsung Bioepis Co., Ltd. has achieved a significant milestone with the US Food and Drug Administration (FDA) granting approval to its Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe). Pyzchiva is now approved for both subcutaneous injection and intravenous infusion, serving … Read more

The US Food and Drug Administration has granted approval for donanemab, a new treatment for Alzheimer’s disease developed by Eli Lilly. This approval follows extensive clinical studies demonstrating that the drug can significantly slow cognitive decline, marking a milestone after years of regulatory delays. Donanemab, branded as Kisunla, will be administered as a monthly injection. … Read more

TauRx Pharmaceuticals Ltd, a global leader in Alzheimer’s disease research focusing on tau proteins, has applied for permission to sell a new drug in the UK. The drug, hydromethylthionine mesylate (HMTM), aims to treat mild cognitive impairment and early to moderate stages of Alzheimer’s dementia. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has … Read more

A federal judge has dealt a blow to a group of cancer victims aiming to block Johnson & Johnson’s proposed bankruptcy settlement over claims that its talc products contain cancer-causing asbestos. The decision, made by U.S. District Judge Michael Shipp on Friday, rejected the plaintiffs’ bid for a preliminary order to prevent J&J from pursuing … Read more

Altimmune, a biotech company relatively unknown until now, is aiming to disrupt the weight loss medication market dominated by giants like Novo Nordisk. Their lead program, pemvidutide, is showing promising results in clinical trials, posing a potential challenge to Novo Nordisk’s Wegovy, a popular weight loss drug. In trials, patients treated with pemvidutide showed significant … Read more

Merck’s Capvaxive, the world’s first pneumococcal disease vaccine tailored for adults, has cleared a crucial hurdle in its challenge against Pfizer’s Prevnar franchise. Following its recent approval, the vaccine received unanimous backing from the CDC’s Advisory Committee on Immunization Practices (ACIP) this week, with one abstention. ACIP’s endorsement extends Capvaxive to adults aged 65 and … Read more

Illumina, the leading name in sequencing technology, is bracing for a hefty financial blow following its spinoff of cancer testing firm Grail. The company revealed in a recent SEC filing that it expects to take a substantial hit of $1.47 billion in goodwill impairment charges for the second quarter of 2024, along with an additional … Read more

In a setback for Rocket Pharmaceuticals, the FDA has issued a Complete Response Letter rejecting its gene therapy, Kresladi, designed to treat severe leukocyte adhesion deficiency-I (LAD-I). The agency’s decision comes with a request for additional chemistry, manufacturing, and controls (CMC) information to complete their review process. Initially slated for a March 2024 decision, Kresladi’s … Read more

The Subject Expert Committee (SEC), an advisory body to India’s national drug regulator, has recommended granting permission for the import and marketing of Eli Lilly’s weight loss drug, Mounjaro, in India. This recommendation is contingent upon the company conducting phase IV clinical trials and meeting quality standards. Eli Lilly sought approval to import and market … Read more

The Tamil Nadu Pharma Traders’ Association (TNPTA) has raised concerns over the promotional strategies of MedPlus, a prominent chain pharmacy group, urging the All India Organisation of Chemists and Druggists (AIOCD) to intervene. TNPTA President T Natarajan penned a letter to the AIOCD’s general secretary, calling for action against Akums Drugs and Pharmaceuticals, a major … Read more