According to Zambon, the FDA has granted Fast Track designation to the company's liposomal cyclosporine A for inhalation (L‑CsA‑i), which is in Phase 3 development for the treatment of bronchiolitis obliterans syndrome (BOS). Zambon acquired L‑CsA‑i developer Breath Therapeutics, a spin off of PARI Pharma, in July 2019. L-CsA-i has already received orphan drug … [Read more...] about Zambon’s inhaled liposomal cyclosporine A for bronchiolitis obliterans gets Fast Track designation
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Avalyn Pharma raises $35.5 million for development of inhaled pirfenidone
Avalyn Pharma (formerly Genoa Pharmaceuticals) announced that it has raised $35.5 million in a Series B financing round led by Norwest Venture Partners. The proceeds will fund a Phase 2/3 trial Avalyn's AP01 nebulized pirfenidone for the treatment of chronic lung allograft dysfunction in lung transplant patients. AP01 is also in development for the treatment of … [Read more...] about Avalyn Pharma raises $35.5 million for development of inhaled pirfenidone
2020 Charles G. Thiel Award goes to Jeff Weers
Digital RDD 2020 got underway on April 26 with the announcement of the winner of the Charles G. Thiel Award for Outstanding Research and Discovery in Respiratory Drug Delivery. In a recorded presentation accessible to registered delegates, committee member Peter Byron announced that this year's award goes to Jeffry Weers, Chief Technology Officer of Respira … [Read more...] about 2020 Charles G. Thiel Award goes to Jeff Weers
Inhalation Sciences sells its remaining shares in spinoff Ziccum
Inhalation Sciences (ISAB) announced that it has sold all of its remaining shares in its spinoff Ziccum AB, a spray drying specialist, for a total of approximately SEK 21.2 million. In May 2019, ISAB announced that it was selling 40,000 shares of Ziccum to finance a study necessary to validate its PreciseInhale dosing system for clinical use. With the sale of the … [Read more...] about Inhalation Sciences sells its remaining shares in spinoff Ziccum
More management changes for Adherium
Less than two weeks after announcing the promotion of Mike Motion from Chief Commercial Officer to Chief Operating Officer, inhaler monitoring company Adherium has named Motion as its new CEO, replacing interim CEO Jeremy Curnock Cook. The company also announced that it has hired former Menarini Asia-Pacific CFO Anne Bell as Chief Financial Officer. In November … [Read more...] about More management changes for Adherium
Alpha Cognition and Linical partner on potential intranasal therapy for Alzheimer’s disease
Alpha Cognition Inc. (formerly Neurodyn Cognition) and CRO Linical have announced Linical will provide consulting services related to potential development of Alpha Cognition's Alpha-1062 acetyl choline esterase inhibitor (AChEI) for the treatment of Alzheimer's disease. Linical's services are expected to encompass a range of areas, including regulatory guidance, … [Read more...] about Alpha Cognition and Linical partner on potential intranasal therapy for Alzheimer’s disease
Phase 2a trial of Biomarck’s inhaled peptide for acute respiratory distress syndrome meets its primary endpoint
Biomarck Pharmaceuticals said that a Phase 2a clinical trial of its BIO-11006 inhalation solution in patients with acute respiratory distress syndrome (ARDS) met its primary endpoint, with a 43% decrease in mortality at 28 days compared to placebo. According to Biomarck, previous studies have shown that BIO-11006, the 10 amino acid N-terminal of a protein called … [Read more...] about Phase 2a trial of Biomarck’s inhaled peptide for acute respiratory distress syndrome meets its primary endpoint
Theravance Biopharma initiates Phase 1 study of TD-0903 inhaled JAK inhibitor
Theravance Biopharma said that a Phase 1 study of its TD-0903 nebulized JAK inhibitor is now underway. Earlier this month, Theravance announced that it intended to begin clinical development of TD-0903 for the prevention of cytokine storm, which can lead to acute respiratory distress syndrome, in patients hospitalized due to COVID-19. The Phase 1 SAD/MAD study … [Read more...] about Theravance Biopharma initiates Phase 1 study of TD-0903 inhaled JAK inhibitor
BlueWillow announces appointment of Chad Costley as Chief Medical Officer
Intranasal vaccine developer BlueWillow Biologics has announced the appointment of Chad Costley as Chief Medical Officer. Costley, an Atlanta-based primary care physician, has previously served on BlueWillow's board of directors. BlueWillow, formerly known as NanoBio, has a number of intranasal vaccines based on its NanoVax technology in preclinical or Phase 1 … [Read more...] about BlueWillow announces appointment of Chad Costley as Chief Medical Officer
FDA approves Aurobindo’s generic albuterol sulfate inhalation solution, cites “increased demand” for albuterol inhalers due to COVID-19
The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA's COVID-19 "Daily Roundup" and was promoted by agency social media accounts. Although the FDA does not currently list albuterol sulfate inhalation solution on its drug shortages … [Read more...] about FDA approves Aurobindo’s generic albuterol sulfate inhalation solution, cites “increased demand” for albuterol inhalers due to COVID-19