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Hikma re-starts launch of its generic version of Advair Diskus

Hikma Pharmaceuticals said that the FDA has approved an amendment to the company's ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time. Hikma … [Read more...] about Hikma re-starts launch of its generic version of Advair Diskus

NeuroRx and Relief Therapeutics publicly air disputes over Zyesami collaboration agreement

NeuroRx and Relief Therapeutics have each issued press releases enumerating disagreements between the companies regarding development of Zyesami aviptadil (RLF-100), a synthetic vasoactive intestinal peptide. The two companies are partnered on development of the formulation for the treatment of acute respiratory distress syndrome caused by COVID-19, for both … [Read more...] about NeuroRx and Relief Therapeutics publicly air disputes over Zyesami collaboration agreement

Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study

Virpax Pharmaceuticals announced that a study of its MMS019 powder "masking spray" in mice demonstrated "a marked inhibition of viral replication in the mouse nasal passages" for mice infected with SARS-CoV-2 and then given MMS019 intranasally for 6 days. Virpax licensed MMS019 from Nanomerics in August 2020 and is developing the formulation for the prevention of … [Read more...] about Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study

GH Research raises $125 million for development of inhaled 5-MeO-DMT

GH Research Ireland has closed a $125 million Series B financing round to fund development of its GH001 inhaled 5-MeO-DMT, the company announced. 5-MeO-DMT is psychedelic found in the venom of certain toads. GH is currently developing GH001 for the treatment of treatment resistant depression, and according to the announcement, "The company's goal is to administer … [Read more...] about GH Research raises $125 million for development of inhaled 5-MeO-DMT

Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J

Johnson & Johnson has decided not to exercise an option acquired in a 2020 agreement with Pulmatrix for development and commercialization of Pulmatrix's portfolio of inhaled narrow spectrum kinase inhibitors (NSKIs), including PUR1800. J&J's Lung Cancer Initiative had been interested in developing the dry powder formulation for lung cancer … [Read more...] about Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J

AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive

AIM ImmunoTech has announced that it will definitely advance an intranasal formulation of its Ampligen rintatolimod into a Phase 2 trial after the initial dose tested in a Phase 1 study showed no safety problems. The company announced initiation of the Phase 1 study, which is set to enroll 40 healthy subjects, in March 2021. The Phase 1 study began with a 75 μg dose … [Read more...] about AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive

Seelos says it has signed an agreement to use Aptar Pharma’s BDS device for its intranasal ketamine

Seelos Therapeutics has signed a strategic device partnership agreement with Aptar Pharma for the use of Aptar's Bidose Liquid System (BDS) for Seelos' SLS-002 intranasal ketamine, Seelos said. SLS-002 is in Phase 2 development for the treatment of suicidal ideation in patients with major depressive disorder. The company noted that the agreement also includes the … [Read more...] about Seelos says it has signed an agreement to use Aptar Pharma’s BDS device for its intranasal ketamine

FDA approves Tyvaso inhalation solution for the treatment of PH-ILD

According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension since July 2009. United Therapeutics submitted the sNDA for the PH-ILD indication in August 2020, … [Read more...] about FDA approves Tyvaso inhalation solution for the treatment of PH-ILD

Iconovo to develop inhaled COVID-19 vaccine delivered by the ICOone device for ISR

According to Iconovo, Swedish immunotherapy developer Immune System Regulation (ISR) will pay up to 18.1 million Swedish kronor plus potential royalties for development of a dry powder COVID-19 vaccine delivered via Iconovo’s ICOone single dose DPI. The deal also includes an option for ISR to use the ICOone device for delivery of vaccines for other respiratory … [Read more...] about Iconovo to develop inhaled COVID-19 vaccine delivered by the ICOone device for ISR