The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted against the efficacy and safety of Insmed's ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) for all patients but voted in favor of its efficacy and safety for patients with limited or no other … [Read more...] about FDA advisory committee votes in favor of ALIS inhalation solution for patients with limited or no other treatment options
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FDA accepts NDA for Ryaltris, sets PDUFA date
The FDA has accepted Glenmark Pharmaceuticals' NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019, the company said. Glenmark announced submission of the NDA in May 2018. Positive results from Phase 3 studies of Ryaltris … [Read more...] about FDA accepts NDA for Ryaltris, sets PDUFA date
New partnership formed for development of inhaled gene therapy for cystic fibrosis
Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC), Imperial Innovations, and Oxford BioMedica have formed a partnership for development of an inhaled therapy designed to introduce a healthy copy of the CFTR gene into lung cells. Boehringer Ingelheim will finance the development and has acquired the option to license exclusive global … [Read more...] about New partnership formed for development of inhaled gene therapy for cystic fibrosis
DFE Pharma announces improved supply of inhalation grade lactose
According to DFE Pharma, the company has significantly increased production capacities of its excipients, including all of its inhalation grade lactose products. The company said that it achieved the improved supply through investments at facilities in the Netherlands, Germany, and India. Inhalation grade lactose is produced at the plant in Veghel, the … [Read more...] about DFE Pharma announces improved supply of inhalation grade lactose
Cohero Health announces new management hires
Cohero Health has announced 5 new hires "to scale for growth and drive commercial sales of its BreatheSmart platform." In 2016, Cohero and H&T Presspart announced that they had partnered on development of an electronic inhaler called the eMDI. The new hires are: Amber Thompson, Chief Client Officer; Sergio Carbone, Chief Information and Technology Officer; Yury … [Read more...] about Cohero Health announces new management hires
Eli Lilly submits NDA, MAA for intranasal glucagon
During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe hypoglycemia in diabetes patients taking insulin. Lilly acquired worldwide rights to the nasal glucagon powder from Locemia in 2015. The MAA was submitted under … [Read more...] about Eli Lilly submits NDA, MAA for intranasal glucagon
Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US
MannKind Corporation has signed an agreement with Tanner Pharma Group for distribution of Afrezza inhaled insulin in regions outside of the US, the company said. The agreement covers regions where Afrezza is not yet approved, and Tanner Pharma Group subsidiary TannerGAP will manage the distribution in those areas. In 2017, Mannkind announced that Biomm would … [Read more...] about Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US
Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a strategic advisor, the company said. The company also announced a public offering of common stock, with shares priced at $11.50 … [Read more...] about Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor
According to Adherium, the FDA has granted 510(k) clearance for OTC sales of the company's Hailie adherence monitoring sensor for use with several MDIs for the treatment of asthma. In March 2018, the FDA granted 510(k) clearance for OTC sales of the sensor for use with Symbicort; the new clearance covers use with ProAir HFA, Ventolin HFA, and Flovent HFA. The … [Read more...] about Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor
Igor Gonda: Cloud medicine is not just a pie in the sky for OINDPs
I am sure that I was not alone to conclude after the 2018 Respiratory Drug Delivery Conference that the most profoundly important session was “Exploring the Benefits of Smart Inhalers on Public Health.” And I immediately thought about the ambitions we had at Aradigm Corporation for our SmartMist device – the first “electronic inhaler.” Smartmist was really smart: … [Read more...] about Igor Gonda: Cloud medicine is not just a pie in the sky for OINDPs