More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
Asalyxa Bio Inc. has closed on an oversubscribed seed financing of more than $2 million designed to advance its lead candidate, ASX-100, into the clinic in acute respiratory distress syndrome.
San Diego area startup Endeavor Biomedicines Inc. launched in January 2021, with a $62 million series A financing from Omega Funds, Longitude Capital and its own management team. The company is working on one asset, ENV-101 or taladegib, a small-molecule inhibitor targeting the Hedgehog pathway, which it plans to develop for the treatment of idiopathic pulmonary fibrosis (IPF).
An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01, a recombinant human single-chain urokinase plasminogen activator for loculated pleural effusion (LPE).
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%.
LONDON – Enterprise Therapeutics Ltd. has sold its TMEM16A cystic fibrosis portfolio to Roche Holding AG for an up-front payment of £75 million (US$96.9 million), with more to come on achievement of predetermined milestones.
DUBLIN – Galecto Biotech Inc. raised $64 million in a series D funding round, which will enable the company to complete a phase IIb trial of its lead drug candidate, the inhaled galectin-3 inhibitor GB-0139, in idiopathic pulmonary fibrosis, and to move two other programs into phase II studies, in liver fibrosis and myelofibrosis, before year-end.
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