The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the company said. The EMA's CHMP had adopted a positive opinion regarding the MAA for Trixeo Aerosphere in October … [Read more...] about Trixeo Aerosphere approved by EU for the treatment of COPD
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Opiant gets additional $3.5 million from BARDA for development of intranasal nalmefene
According to Opiant Pharmaceuticals, the US Biomedical Advanced Research and Development Authority (BARDA) is providing an additional $3.5 million for development of Opiant's OPNT003 nalmefene nasal spray for the treatment of opioid overdose. BARDA had previously provided $4.6 million. The company has also received funding from the National Institute on Drug … [Read more...] about Opiant gets additional $3.5 million from BARDA for development of intranasal nalmefene
Phase 1b trial of TFF’s voriconazole DPI in asthma patients is underway
TFF Pharmaceuticals announced that the first subjects have been dosed in a Phase 1b clinical trial of its dry powder voriconazole, which it is developing for the treatment of invasive pulmonary aspergillosis. The trial is expected to enroll 30 adult asthma patients and will evaluate two doses of voriconazole, 40 mg and 80 mg, versus placebo. In September 2020, the … [Read more...] about Phase 1b trial of TFF’s voriconazole DPI in asthma patients is underway
Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine
Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix's CodaVax-RSV vaccine, which is also in Phase 1 development, COVI-VAC is based on Codagenix's SAVE codon … [Read more...] about Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine
Vectura to add facility for development of highly potent inhaled drugs
CDMO Vectura, which specializes in inhaled drug development and manufacturing, announced that it is adding new product development capabilities for handling highly potent APIs. The new laboratory, which will be located at the company's Chippenham, UK facility, is expected to be ready for use in early 2021. The new lab will have six containment isolators to house … [Read more...] about Vectura to add facility for development of highly potent inhaled drugs
CHMP adopts positive opinion regarding expanded indication for Spravato
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen's Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato "as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement … [Read more...] about CHMP adopts positive opinion regarding expanded indication for Spravato
UofL researchers get $8.5 million from US Department of Defense for Q-Griffithsin nasal spray development
The US Department of Defense is providing $8.5 million to fund development of a Q-Griffithsin (Q-GRFT) nasal spray at the University of Louisville, the university said. The funding will support the PREVENT-CoV project for development of a once-daily nasal spray for the prevention of viral infections through a Phase 1 study. Researchers say that because they already … [Read more...] about UofL researchers get $8.5 million from US Department of Defense for Q-Griffithsin nasal spray development
Cyrano raises almost $13 million for Phase 2 trial of intranasal theophylline to restore sense of smell
Cyrano Therapeutics announced that it has raised $12.8 million in Series A financing to allow it to complete a Phase 2 trial of its CYR-064 intranasal theophylline for the restoration of the senses of smell and taste. In October 2017, Cyrano announced that it had partnered with Shanghai Newsummit Biopharma for development of the nasal spray in China; the new funding … [Read more...] about Cyrano raises almost $13 million for Phase 2 trial of intranasal theophylline to restore sense of smell
Savara halts development of AeroVanc, Apulmiq
Savara Pharmaceuticals has announced that it is halting development of its AeroVanc vancomycin DPI after the Phase 3 AVAIL trial of AeroVanc for the treatment of MRSA lung infections in cystic fibrosis patients failed to meet its primary endpoint. The AVAIL trial, which was initiated in 2017, failed to show statistically significant improvement in lung function or a … [Read more...] about Savara halts development of AeroVanc, Apulmiq
United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF
According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation's benefits applying to both Tyvaso inhalation solution and Treprostinil Technosphere dry powder treprostinil. United Therapeutics also said that the FDA has cleared the company's IND … [Read more...] about United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF