Osimertinib mesylate

The European Medicine Agency's drug advisory panel recommended the approval of several new medicines on Friday, but also issued a negative opinion on a pair of drugs. The most notable therapy to receive a nod from the Committee for Medicinal Products for Human Use (CHMP) was Eisai and Biogen’s Alzheimer's disease drug Leqembi (lecanemab), reversing an earlier thumbs-down. Joining Leqembi in the greenlit group are Bristol Myers Squibb's Augtyro (repotrectinib), InflaRx's Gohibic (vilobelimab) and Johnson & Johnson's Lazcluze (lazertinib).Augtyro, a next-generation tyrosine kinase inhibitor (TKI), was recommended for adults with ROS1-positive advanced non–small-cell lung cancer (NSCLC), as well as for adults and paediatric patients ages 12 years and older with advanced solid tumours expressing a NTRK gene fusion. The FDA in June granted the drug a tumour-agnostic approval to treat solid cancers harbouring NTRK gene fusions.InflaRx's product is a human complement factor C5a-targeting monoclonal antibody (mAb) designed to control inflammatory response-driven tissue and organ damage. The CHMP recommended its use in adults with acute respiratory distress syndrome (ARDS) due to COVID-19 who are receiving systemic corticosteroids and receiving invasive mechanical ventilation. The mAb was given Emergency Use Authorisation by the FDA in April 2023. J&J's CHMP nod covers the combination of Lazcluze with Rybrevant (amivantamab-vmjw) to treat first-line, advanced NSCLC in adults with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The former is an EGFR tyrosine kinase inhibitor and the latter is an EGFR/MET-targeting bispecific.The duo was approved by the FDA in August for frontline NSCLC, where it is seeking to displace AstraZeneca's Tagrisso (osimertinib) as the market leader (see – Spotlight On: Experts sceptical that J&J can challenge AstraZeneca's dominance of the EGFRm lung cancer market).Those receiving negative CHMP opinions include Legacy Healthcare's herbal hair loss hopeful Cinainu (allium/citrus/paullinia/cacao) and Orphelia Pharma's chemotherapy temozolomide for neuroblastoma.

With around $2 billion of the investment dedicated to creating more than a thousand U.S. jobs, AstraZeneca is looking to expand R&D and manufacturing facilities in states including Massachusetts, Maryland, and Texas dedicated to specialty manufacturing, biologics and cell therapies. The £158.7 billion ($200.8 billion) market-cap player is among the top ten biggest pharmaceutical companies in the world, with landmark products including the small molecule diabetes drug dapagliflozin (Farxiga) and cancer medications osimertinib (Tagrisso) and acalabrutinib (Calquence). AstraZeneca’s latest investment in the U.S. comes as part of the company’s mission to expand its research and manufacturing capabilities by the end of 2026 and to hit $80 billion in total revenue by 2030. “Our multibillion dollar investment reflects the attractiveness of the business environment together with the quality of talent and innovation capabilities here in the United States,” said AstraZeneca CEO Pascal Soriot in a public statement ​. “By expanding our R&D and manufacturing footprint, we aim to enhance the development of cutting-edge therapies and support the United States leadership in healthcare innovation.” AstraZeneca’s move echoes those of other pharmaceutical firms increasing their foothold in the lucrative U.S. market, which makes up 44% of AstraZeneca’s revenue. For example, GSK recently sank ​ $800 million into a site in Pennsylvania to double its capacity, while Novo Nordisk earmarked $4.1 billion for a new manufacturing facility in North Carolina earlier this year ​. googletag.cmd.push(function () { googletag.display('text-ad1'); }); AstraZeneca unveiled a 19% increase in its total revenue to $39.1 billion over the last nine months in a recent earnings report ​, which was driven by growth in product sales and income from partnered candidates. The firm now sees high teens percentage growth in its total revenue for the whole year 2024. Some of the biggest earners for AstraZeneca this year include Farxiga with $5.7 billion, Tagrisso with $4.8 billion and durvalumab (Imfinzi) with $3.4 billion. However, it is not all smooth sailing for the big pharma company, with some of its current and former employees, including EVP International and AstraZeneca China President Leon Wang, under investigation in China with allegations of medical insurance fraud, illegal drug importation and personal information breaches. “We take the matters in China very seriously. If requested we will fully cooperate with the authorities,” stated Soriot in the earnings report.