A Texas-based company founded as Lung Therapeutics in 2013 and acquired by Aileron Therapeutics in 2023 announced that it has now changed its name to Rein Therapeutics. Lung Therapeutics spun off TFF Pharmaceuticals in 2018 to develop dry powders based on thin film freezing technology licensed from the University of Texas. Rein Therapeutics President and CEO … [Read more...] about Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF
News
GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA's 2023 clinical hold on an IND that the company had submitted for a Phase 1 study of GH001 for the treatment of treatment-resistant depression. In addition, the company announced that 2 Phase 2a proof of … [Read more...] about GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Leyden Labs raises $70 million for development of its intranasal vaccine platform
Intranasal vaccine developer Leyden Laboratories announced the closing of a $70 million funding round, with proceeds going to support development of prophylactic nasal sprays based on the company's "Mucosal Protection Platform." Leyden Labs, which initiated a Phase 1 trial of its lead candidate, PanFlu intranasal CR9114 anti-hemagglutinin stem human antibody, in … [Read more...] about Leyden Labs raises $70 million for development of its intranasal vaccine platform
Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients
Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with moderate-to-severe COPD who will receive daily fexlamose for 28 days. Aer said that it expects to have top-line data available in January … [Read more...] about Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients
Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine
Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company's RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the FDA had cleared an IND for the trial, which is expected to enroll 24 healthy adults who are current cigarette smokers. Results from … [Read more...] about Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine
Phillips Medisize parent company Molex completes acquisition of Vectura
Phillips Medisize announced that its parent company Molex has completed its acquisition of inhalation CDMO Vectura, which was initially announced in September 2024. According to the announcement, the acquisition covers all of Vectura's assets in addition to its OINDP analysis and development services business, which employs 350 people. Vectura's intellectual property … [Read more...] about Phillips Medisize parent company Molex completes acquisition of Vectura
Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.
Arcturus Therapeutics announced that it initiated 2 studies in December 2024, one of which is a Phase 2 MAD trial of ARCT-032 inhaled mRNA therapy in cystic fibrosis patients. The company announced in September 2024 that the FDA had cleared its IND for the study, which is expected to enroll 12 adults with CF who do not benefit from CFTR modulators and will evaluate 3 … [Read more...] about Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.
ARS Pharma files for regulatory approval of neffy epinephrine nasal spray in Canada and in the UK
ARS Pharmaceuticals announced that it has submitted marketing applications for neffy epinephrine (adrenalin) nasal spray in Canada and in the UK. The nasal spray has been approved in the US and in Europe (as EURneffy) for the treatment of anaphylaxis in adults and in children weighing ≥30 kg since August 2024. In November 2024, ALK-Abelló acquired the rights to market … [Read more...] about ARS Pharma files for regulatory approval of neffy epinephrine nasal spray in Canada and in the UK
Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded
Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company's Adrenalin epinephrine for injection. As a result of the potential for confusion, Endo said, "FDA has determined the product to be misbranded … [Read more...] about Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded
Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium
Aridis Pharmaceuticals said that "an undisclosed pharmaceutical company" has agreed to pay $6.5 million plus annual royalty payments for Aridis' AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis. Aridis said that it expects to receive 50% of the upfront payment by the end of the first quarter of 2025 and the other … [Read more...] about Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium