According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent's generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD. The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of … [Read more...] about FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus
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AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen
AIM ImmunoTech said that it has extended a 2020 agreement with Shenzhen Smoore Technology related to development of an inhaled version of its Ampligen rintatolimod for the treatment of COVID-19. The agreement with Smoore is for the use of a Smoore-designed "personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA." According to … [Read more...] about AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen
EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
The EMA’s COVID-19 task force has said "that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19." In addition, the task force said that "it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen." Evidence cited by the … [Read more...] about EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
MHRA approves Nasacort nasal spray for general sale
The UK Ministry of Healthcare Products Regulatory Agency (MHRA) announced that it has approved an application from Aventis Pharma (Sanofi) to reclassify Nasacort Allergy Relief triamcinolone acetonide nasal spray for the treatment of allergic rhinitis in patients aged 18 and over from a pharmacy (P) medicine to a general sales list (GSL) product. Nasacort was approved … [Read more...] about MHRA approves Nasacort nasal spray for general sale
Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19
According to North Carolina-based startup Inhalon Biopharma, the US Army Medical Research & Development Command (USAMRDC) has awarded the company a contract worth $7 million for a Phase 1/2a study of its IN-006 inhaled neutralizing monoclonal antibody for the treatment of COVID-19 in an outpatient setting. The company expects topline results to be available in … [Read more...] about Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19
Inhalation Sciences gets approval for PreciseInhale trial
The Swedish Medical Product Agency (Läkemedelsverket) has approved an application from Inhalation Sciences (ISAB) for a clinical trial of its PreciseInhale aerosol generation system, the company said. ISAB expects to initiate the trial in June 2021 and to complete the study by the end of the year. Inhalation Sciences first announced its intentions to validate … [Read more...] about Inhalation Sciences gets approval for PreciseInhale trial
VistaGen initiates Phase 3 trial of PH94B aloradine nasal spray for social anxiety disorder
VistaGen Therapeutics has announced the initiation of the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. In July 2020, the company announced details of the proposed trial, which is expected to enroll approximately 200 … [Read more...] about VistaGen initiates Phase 3 trial of PH94B aloradine nasal spray for social anxiety disorder
Vectura to be acquired by the Carlyle Group
A newly formed company called Murano Bidco, which is controlled by the Carlyle Group, has agreed to pay approximately £958 million to acquire inhalation CDMO Vectura, the companies have announced. According to the announcement, Bidco was formed specifically for the purpose of acquiring Vectura. Vectura Chairman Bruno Angelici commented, "Vectura has made strong … [Read more...] about Vectura to be acquired by the Carlyle Group
Inhalation Sciences forms new scientific advisory board
Aerosol research instrument company Inhalation Sciences (ISAB) has announced the formation of a new scientific advisory board, which will begin meeting on June 1, 2021 to discuss how the company's PreciseInhale laboratory aerosol dosing system can be used once it has been validated for clinical use. Members of the new scientific advisory board include Carsten Ehrhardt … [Read more...] about Inhalation Sciences forms new scientific advisory board
GSK sells its stake in Innoviva
Innoviva is buying back GlaxoSmithKline's entire stake in the company, a total of 32 million shares (~ 32% of company). Innoviva (formerly Theravance, Inc.), was spun off from Theravance in 2013 to manage the royalties from dry powder inhalers that Theravance developed in partnership with GSK, including Relvar/Breo Ellipta, Anoro Ellipta, and Trelegy Ellipta. GSK will … [Read more...] about GSK sells its stake in Innoviva