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
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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
Experic raises $14 million in Series B financing led by Harro Höfliger
CDMO Experic, which offers development and manufacturing services for DPIs, announced that it has closed a $14 million series B funding led by East Seattle Partners and inhaler filling experts Harro Höfliger Packaging Systems. The company said that the new investment will go toward expansion of its facility in Cranbury, NJ, USA in response to "extraordinary … [Read more...] about Experic raises $14 million in Series B financing led by Harro Höfliger
Q&A with Mark Copley: Reducing Inhaler Testing Variability Through Test Environment Control
Copley Scientific CEO Mark Copley answers questions about the importance of the test environment for OIP testing Why is the test environment so important for inhaler testing? Due to a broad range of factors, including interaction between formulation, device, and patient, orally inhaled product (OIP) testing is naturally more variable than testing for simple … [Read more...] about Q&A with Mark Copley: Reducing Inhaler Testing Variability Through Test Environment Control
Micro-Sphere adds lab-scale electrostatic spray drying capabilities
CDMO Micro-Sphere, which offers spray drying and capsule filling for DPI formulations, said that it has now added new particle engineering R&D space with FluidAir PolarDry electrostatic spray drying technology. The company recently announced the addition of new inhalation testing laboratory space at its site in Monteggio, Switzerland. The PolarDry system works at … [Read more...] about Micro-Sphere adds lab-scale electrostatic spray drying capabilities