Kexing Biopharm announced that has initiated a Phase 3 trial of human Interferon α1b inhalation solution, which the company is developing for the treatment of children with pneumonia or bronchiolitis associated with respiratory syncytial virus. According to Kexing, a Phase 1 trial of the inhalation solution was completed in October 2023 and demonstrated low systemic … [Read more...] about Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
News
Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
Chiesi has announced the initiation of a Phase 3 safety study of CHF5993 beclometasone / formoterol / glycopyrronium HFA 152a MDI, an LGWP propellant version of Trimbow MDI, which uses HFA 134a as a propellant. In December 2019, Chiesi announced that it planned to bring an HFA 152a inhaler to market by the end of 2025. The Phase 3 trial will compare the HFA 152a … [Read more...] about Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed … [Read more...] about ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
Lonza now offers spray drying of proteins for inhalation
Lonza has announced that its Center of Excellence for respiratory formulations in Bend, OR, US can now offer kilogram scale spray drying of proteins for inhalation. With the latest expansion, the company is now able to serve customers who need clinical and/or commercial manufacturing for protein DPI formulations. Lonza Director, Respiratory Delivery, Kimberly … [Read more...] about Lonza now offers spray drying of proteins for inhalation
Bespak spins out from Recipharm, will focus on LGWP transition
Bespak will go forward as a standalone CDMO after separating from former parent company Recipharm in order to focus on the transition to lower global warming potential (LGWP) propellants, the company announced. The new Bespak Group will be led by the former President of Recipharm's Advanced Delivery Systems Business Unit, Chris Hirst, as CEO, and former Teva CEO Kåre … [Read more...] about Bespak spins out from Recipharm, will focus on LGWP transition
Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Acorda Therapeutics announced that it has filed to begin Chapter 11 bankruptcy proceedings and said that Merz Therapeutics will serve as a "stalking horse" bidder for Acorda's assets, including the rights to Inbrija inhaled dry powder levodopa. Other potential buyers can submit bids for the company's assets, with the court-supervised sale expected to be completed by … [Read more...] about Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-3 public speaking trial of fasedienol (PH94B) nasal spray in people with social anxiety disorder. In August 2023, the company announced that the Phase 3 PALISADE-2 trial had met its primary endpoint although that study was closed early and enrolled only about 2/3 of the expected number of subjects. The … [Read more...] about Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Liquidia Corporation announced today that the expiration of United Therapeutics' new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with court rulings on March 28 and March 29, has cleared the way for the FDA to issue final … [Read more...] about Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Launch Therapeutics will take over management of clinical trials of Teva’s TEV-‘248 fluticasone / albuterol (salbutamol) DPI for the treatment of asthma, the companies have announced. In addition, Carlyle Group subsidiary Abingworth, a Launch Therapeutics backer, will invest up to $150 million toward funding continued development of TEV-'248 and would receive … [Read more...] about Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth