South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
Interstitial lung fibrotic disease (ILD) is characterized by inflammation and fibrosis of lung tissue and is associated with poor prognosis. Gat Therapeutics SL has developed GTX-011, an orally available small molecule for treating fibrotic diseases.
α1-Antitrypsin deficiency is a hereditary disorder that affects the liver in children and adults, as well as the lungs in adults. The disease is mostly caused by the Z allele mutation in the SERPINA1 gene, where a glutamic acid amino acid is substituted by lysine (E342K) leading to protein misfolding and aggregation.
GSK plc’s interleukin-5 (IL-5) portfolio got boost as depemokimab, an ultra-long-acting biologic targeting IL-5, hit its endpoints in two phase III trials in severe asthma, setting up potential filings for the first therapy that could allow patients a six-month dosing schedule.
Shanghai Rulink Biopharma Co. Ltd. has synthesized integrin αvβ1, αvβ6 and/or αvβ8 antagonists reported to be useful for the treatment of idiopathic pulmonary fibrosis and primary sclerosing cholangitis.
With positive phase IIa data for ENV-101 in idiopathic pulmonary fibrosis (IPF) in hand, showing some lung damage was reversed, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication.
Johnson & Johnson is adding to its dermatology portfolio with the $850 million purchase of privately held Proteologix Inc. The Redwood City, Calif.-based company brings with it two bispecific antibodies into a space dominated by the blockbuster injectable Dupixent (dupilumab). Proteologix has PX-128, which targets IL-13 plus thymic stromal lymphopoietin for treating moderate to severe atopic dermatitis and moderate to severe asthma, and PX-130, which also targets IL-13 plus IL-22, for treating moderate to severe AD. Both are in preclinical development, but Johnson & Johnson said PX-128 is ready for its phase I close-up.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
A pair of co-published filings from Naples, Fla.-based Aerwave Medical Inc. describe apparatus and ultrasound-based methods for bronchial denervation, ablating smooth muscle or goblet cells, and emphysematous tissue remodeling in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease.
Researchers from the University of Pittsburgh have developed a device designed to collect exhaled respiratory aerosols from mechanically ventilated patients. Their device is designed to be non-invasive, highly efficient and can be readily placed in the exhalation line of ventilators without interfering in the functions of the ventilator.
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