The FDA has approved a generic version of AstraZeneca's Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a court had ruled in favor of AstraZeneca in its suit against Mylan and Kindeva Drug Delivery (formerly 3M Drug Delivery). In December 2021, an … [Read more...] about FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
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Sandoz acquires inhaler developer Coalesce Product Development
Declaring that it is "determined to grow its portfolio in the complex generics space," Novartis generics division Sandoz announced its acquisition of device device developer Coalesce Product Development. Coalesce's inhaler technology include MDI, breath-actuated MDI, and DPI platforms. Sandoz said that it "sees respiratory as a key pillar of its ambitious long-term … [Read more...] about Sandoz acquires inhaler developer Coalesce Product Development
University of Liverpool partners with Aerogen on development of inhaled antimicrobials
Researchers from the University of Liverpool have partnered with nebulizer maker Aerogen on a project called "Treatment of Respiratory Infections with inhaled AntimicrobiaLs" (TRIAL), which will develop inhaled therapies for the treatment of bacterial and viral pulmonary infections in hospitalized patients. Funding for the £1.3million project comes from the … [Read more...] about University of Liverpool partners with Aerogen on development of inhaled antimicrobials
Adherium submits 510(k) for Hailie sensor to be used with Ellipta DPIs
Inhaler monitoring company Adherium has announced the submission of a 510(k) for a new Hailie sensor designed specifically for use with Ellipta DPIs. In September 2021, the FDA cleared another version of the next generation Hailie sensor for use with Symbicort MDIs. The sensors, which snap on to the outside of the device, connect to a cloud-based monitoring platform … [Read more...] about Adherium submits 510(k) for Hailie sensor to be used with Ellipta DPIs
Positive Phase 3 results for Optinose’s Xhance intranasal fluticasone propionate for chronic sinusitus
According to Optinose, the Phase 3 ReOpen1 trial of Xhance intranasal fluticasone propionate (OPN-375) in patients with chronic sinusitus met both of its primary endpoints, demonstrating statistically significant reduction in symptoms and in sinus inflammation measured by CT scan compared to placebo. A second Phase 3 trial, ReOpen2, is underway, with results expected … [Read more...] about Positive Phase 3 results for Optinose’s Xhance intranasal fluticasone propionate for chronic sinusitus
Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge … [Read more...] about Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
HCmed, Formosa Laboratories, and Formosa Pharmaceuticals partner on new inhalation CDMO
Device maker HCmed Innovations has partnered with Formosa Laboratories and Formosa Pharmaceuticals to offer contract development and manufacturing services for inhaled drugs, HCmed announced. Formosa Laboratories already offers CDMO services for pharmaceutical products; the new services will also incorporate Formosa Pharmaceutical's nanotechnology platform and HCmed's … [Read more...] about HCmed, Formosa Laboratories, and Formosa Pharmaceuticals partner on new inhalation CDMO
Aerami Therapeutics agreement with FoxWayne has been terminated
In December 2021, inhaled drug developer Aerami Therapeutics announced that it would go public by merging with FoxWayne Enterprises Acquisition Corp, a special purpose acquisition company (SPAC). The two companies have now announced that the deal is off, effective immediately, saying, "In light of current unfavorable market conditions, Aerami and FoxWayne believe that … [Read more...] about Aerami Therapeutics agreement with FoxWayne has been terminated
FDA lifts clinical hold on Penthrox methoxyflurane inhaler
According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP's Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it … [Read more...] about FDA lifts clinical hold on Penthrox methoxyflurane inhaler
FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three … [Read more...] about FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail