Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma's ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they "are committed to bringing this important product to the US market and remain confident in the submission." Hikma said that … [Read more...] about FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
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Study shows Clement Clarke’s Clip-Tone device improves inhaler technique
Clement Clarke International is highlighting the results of a study done in partnership with Egypt's Beni-Suef University Research demonstrating that the company's Clip-Tone audible feedback device can improve MDI technique. The data were presented at the 2020 European Respiratory Society Congress. The Clip-Tone device attaches to the top of an MDI actuator and … [Read more...] about Study shows Clement Clarke’s Clip-Tone device improves inhaler technique
Alaxia partners with University of Padua to evaluate ALX-009 inhalation solution against SARS-CoV-2
French biotech company Alaxia has announced a collaboration with the Department of Molecular Medicine (DMM) at the University of Padua for in vitro testing of its ALX-009 hypothiocyanite / lactoferrin inhalation solution against SARS-CoV-2 as a possible treatment for COVID-19. The company has been developing ALX-009 as an inhaled antimicrobial for the treatment of … [Read more...] about Alaxia partners with University of Padua to evaluate ALX-009 inhalation solution against SARS-CoV-2
Ampio announces planned Phase 1 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals said that the FDA has cleared its IND for clinical trials of an inhaled formulation of its Ampion anti-inflammatory biologic in patients with COVID-19. The company had announced its plans to develop Ampion for the treatment of COVID-19 in March 2020. According to Ampio, preclinical toxicology studies demonstrated that Ampion would be safe for … [Read more...] about Ampio announces planned Phase 1 trial of inhaled Ampion in COVID-19 patients
Teva launches AirDuo Digihaler and ArmonAir Digihaler in the US
Teva Respiratory has launched its AirDuo Digihaler fluticasone propionate / salmeterol and ArmonAir Digihaler fluticasone propionate DPIs in the US, the company said. The company announced the launch of its ProAir Digihaler albuterol sulfate DPI in July 2020. AirDuo Digihaler was approved by the FDA for the treatment of asthma in July 2019, and the agency approved … [Read more...] about Teva launches AirDuo Digihaler and ArmonAir Digihaler in the US
Perrigo announces US recall of albuterol MDIs
Perrigo said that the company stopped production and distribution of its albuterol sulfate metered dose inhalers in the US and has issued a recall of the MDIs "out of an abundance of caution as a result of complaints that some units may not dispense due to clogging." The company noted that the inhalers are manufactured by Catalent Pharma Solutions and said that there … [Read more...] about Perrigo announces US recall of albuterol MDIs
TFF to advance its dry powder voriconazole to Phase 2 after successful Phase 1 trial
TFF Pharmaceuticals has announced that it will advance its voriconazole inhalation powder into Phase 2 development for the treatment of invasive pulmonary aspergillosis following completion of a Phase 1 trial that demonstrated plasma levels that should be sufficient for effective treatment. Topline safety results from the trial were reported in June 2020, and in July, … [Read more...] about TFF to advance its dry powder voriconazole to Phase 2 after successful Phase 1 trial
Starpharma says tests show its astodrimer sodium nasal spray formulation effectively inactivates SARS-CoV-2
Starpharma has announced that testing of its SPL7013 astodrimer sodium intranasal formulation at the Scripps Research Institute demonstrated that the formulation inactivated nearly 100% of SARS-CoV-2 with low cellular toxicity. The company already markets several astodrimer sodium products under the VivaGel brand in a number of countries, including a VivaGel condom … [Read more...] about Starpharma says tests show its astodrimer sodium nasal spray formulation effectively inactivates SARS-CoV-2
Seelos Therapeutics gets Japanese patent for intranasal racemic ketamine
According to Seelos Therapeutics, the Japanese Patent Office has issued Japanese patent number 6722453, titled "Anxiolytic Composition, Formulation and Method of Use," covering the company's SLS-002 intranasal racemic ketamine formulation for treatment of anxiety due to phobias. In addition, the company said that it received a notice of allowance for Japanese patent … [Read more...] about Seelos Therapeutics gets Japanese patent for intranasal racemic ketamine
Vectura to work on Monash University oxytocin DPI
Inhaled drug CDMO Vectura has entered into an agreement with the Monash University Institute of Pharmaceutical Sciences (MIPS) for early development of an oxytocin DPI for the prevention of postpartum hemorrhage, the company said. Vectura will develop a single use inhaler for Phase 1 clinical trials on a fee-for-service basis; a commercial manufacturer would be … [Read more...] about Vectura to work on Monash University oxytocin DPI