According to Virpax Pharmaceuticals, the FDA has provided guidance in response to the company's pre-Investigational New Drug NobrXiol (VRP324) CBD nasal powder, which Virpax is developing for the for the treatment of epilepsy. In September 2021, Virpax announced that it had acquired exclusive worldwide rights to Nanomerics’s molecular envelope technology (MET) for use … [Read more...] about Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
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CF Foundation invests $4.85 million in Aridis Pharmaceuticals to support development of AR-501 inhaled gallium
According to Aridis Pharmaceuticals, the Cystic Fibrosis Foundation has made a $4.85 million investment in Aridis common stock to support continued development of AR-501 nebulized gallium citrate for the treatment of chronic lung infections in CF patients, bringing the CF Foundation's total funding for the project to $12.5 million. AR-501 has been granted orphan, … [Read more...] about CF Foundation invests $4.85 million in Aridis Pharmaceuticals to support development of AR-501 inhaled gallium
FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Vertex Pharmaceuticals said that it plans to initiate a Phase 1 SAD trial of its VX-522 inhaled mRNA therapy after the FDA cleared the company's IND. VX-522 contains lipid nanoparticle-encapsulated mRNA that is designed to treat cystic fibrosis in patients who do not produce cystic fibrosis transmembrane conductance regulator (CFTR) and are therefore not helped by a … [Read more...] about FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Evoke gets new US patent covering Gimoti metoclopramide nasal spray
According to Evoke Pharma, the United States Patent and Trademark Office (USPTO) has issued a new patent covering Evoke's Gimoti metoclopramide nasal spray. The new patent (No. 11,517,545), which expires in 2038, is titled "Treatment of Moderate and Severe Gastroparesis." The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020 and granted 3 … [Read more...] about Evoke gets new US patent covering Gimoti metoclopramide nasal spray
Pulmocide raises $52 million for further development of inhaled opelconazole
Pulmocide announced that it has closed a $52 million a Series C extension round, with the proceeds to be used for continued development of its PC945 inhaled opelconazole for the treatment of invasive pulmonary Aspergillosis (IPA). Opelconazole has been granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations. In December 2021, … [Read more...] about Pulmocide raises $52 million for further development of inhaled opelconazole
FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
According to Emergent BioSolutions, the FDA has accepted the company's supplemental NDA for over-the-counter (OTC) sales of Narcan naloxone nasal spray for the reversal of opioid overdose and has set a PDUFA goal date of March 29, 2023. The sNDA is for a 4mg dose of Narcan, which is the original strength. In 2017, the FDA also approved a 2 mg dose, which has since … [Read more...] about FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint
Gossamer Bio has announced that the TORREY Phase 2 study of its GB002 seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH) met its primary endpoint, demonstrating a statistically significant change in pulmonary vascular resistance (PVR) at Week 24. According to Gossamer, "Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and … [Read more...] about Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint
Vistagen’s PH10 nasal spray gets Fast Track designation
The FDA has awarded Fast Track designation to Vistagen's PH10 pherin nasal spray for the treatment of major depressive disorder, the company said. Vistagen recently announced its plans for a Phase 1 trial of a re-formulated version of PH10 expected to begin in early 2023 after receiving a "Study May Proceed" letter from the agency. Vistagen CEO Shawn Singh said, … [Read more...] about Vistagen’s PH10 nasal spray gets Fast Track designation
Glenn Mattes steps down as CEO of TFF Pharmaceuticals; Harlan Weisman named Interim CEO
TFF Pharmaceuticals, which develops dry powder inhalation products based on its thin film freezing technology, has announced that Glenn Mattes will step down as CEO and that he will be succeeded on an interim basis by Harlan F. Weisman. Mattes joined TFF in 2018. Weisman's experience includes a number of leadership roles at Johnson & Johnson, Centocor, Coronado … [Read more...] about Glenn Mattes steps down as CEO of TFF Pharmaceuticals; Harlan Weisman named Interim CEO
FDA approves Aucta’s generic formoterol fumarate inhalation solution
The FDA has approved Aucta Pharmaceuticals' ANDA for its formoterol fumarate inhalation solution, a generic version of Mylan's Perforomist. Aucta's is the 4th Perforomist equivalent approved since the expiration of Mylan's final patent covering the inhalation solution. Teva launched its generic equivalent in the US in June 2021, and the FDA approved Alembic … [Read more...] about FDA approves Aucta’s generic formoterol fumarate inhalation solution