Pharma News

AstraZeneca’s application for sipavibart has been accepted by the European Medicines Agency (EMA) through an accelerated assessment procedure. This application is specifically for using sipavibart as a preventive treatment (pre-exposure prophylaxis) against Covid-19 in immunocompromised patients. Sipavibart is an experimental long-acting antibody designed to protect immunocompromised patients from Covid-19. These patients often do not respond […]

WHO Issues Landmark Guideline to Boost Global Tobacco Cessation Efforts The World Health Organization (WHO) has released its inaugural guideline on tobacco cessation, urging comprehensive strategies that include behavioral support by healthcare professionals, digital interventions, and pharmacological treatments. Addressing the needs of over 750 million tobacco users worldwide who desire to quit various forms of

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

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.

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

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

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

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

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

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