Biohaven Pharmaceutical said that the FDA has approved the company's IND for a Phase 2 study of its vazegepant intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the reduction of excessive immune response leading to lung injury in COVID-19 patients. Biohaven recently announced that it would advance vazegepant (BHV-3500) into Phase 3 development … [Read more...] about Biohaven gets FDA approval for study of intranasal vazegepant for COVID-19
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Theravance Biopharma intends to begin clinical development of nebulized JAK inhibitor for COVID-19
Theravance Biopharma said that it has submitted a clinical trial application (CTA) to begin clinical development of its TD-0903 nebulized JAK inhibitor for prevention of cytokine storm, which can lead to acute respiratory distress syndrome (ARDS), in hospitalized patients with COVID-19. Theravance initially planned to develop TD-0903 for the prevention of graft … [Read more...] about Theravance Biopharma intends to begin clinical development of nebulized JAK inhibitor for COVID-19
TFF announces collaboration with the University of Georgia and UT Austin on dry powder universal flu vaccine
TFF Pharmaceuticals has announced a research collaboration deal with the University of Georgia’s Center for Vaccines and Immunology (CVI) and with the University of Texas at Austin (UT Austin) for testing of dry powder universal influenza vaccines formulated using TFF's thin film freezing technology. UT Austin will formulate CVI vaccines based on TFF's technology, and … [Read more...] about TFF announces collaboration with the University of Georgia and UT Austin on dry powder universal flu vaccine
Cipla announces results of Phase 3 study for generic of Advair Diskus
Cipla has announced that a Phase 3 study demonstrated therapeutic equivalence of its generic fluticasone propionate/salmeterol DPI (100/50 mcg) to Advair Diskus 100/50 mcg. The 15-month trial enrolled 1400 asthma patients in the US. Cipla Global CEO Umang Vohra commented, “I am extremely pleased with the successful completion of the Phase-3 clinical study of … [Read more...] about Cipla announces results of Phase 3 study for generic of Advair Diskus
Bryn Pharma presents data from Phase 1 study of its intranasal epinephrine
Bryn Pharma announced the publication of a poster presenting data from a Phase 1 PK/PD study of its BRYN-NDS1C intranasal epinephrine, which is delivered via an Aptar Pharma Bidose nasal device. In October 2019, Bryn announced that it had raised $17.5 million for development of BRYN-NDS1C, which has received Fast Track designation from the FDA. The study, which … [Read more...] about Bryn Pharma presents data from Phase 1 study of its intranasal epinephrine
UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
The University of Wisconsin–Madison has announced that virologists from the university have partnered with vaccine companies FluGen and Bharat Biotech on development of an intranasal vaccine against unique vaccine against SARS-CoV-2 for the prevention of COVID-19. FluGen, a UW spin off co-founded by faculty member Yoshihiro Kawaoka, will create the vaccine and … [Read more...] about UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
Swiss biotech Neurimmune has partnered with German mRNA specialist Ethris to develop inhaled mRNA-encoded neutralizing anti-SARS-CoV-2 antibodies for the treatment of Covid-19, the companies said. The goal is to begin clinical manufacturing of the drug this summer and initiate clinical trials in the fourth quarter of this year. The proposed COVID-19 therapy would … [Read more...] about Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
Austrian biotech APEPTICO said that it has signed a grant agreement with the European Commission to accelerate the availability of the company's solnatide (AP301), an inhaled peptide, available for treatment of patients with severe COVID-19. APEPTICO had been invited to apply for a grant through the Horizon 2020 “Advancing knowledge for the clinical and public health … [Read more...] about APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
Altimmune and UAB partner to develop intranasal COVID-19 vaccine
Altimmune has announced a collaboration with the University of Alabama at Birmingham (UAB) for development of an intranasal COVID-19 vaccine. Six laboratories at UAB are expected to work on the single dose vaccine, called AdCOVID, to complete immunogenicity and pre-clinical studies with the goal of initiating a Phase 1 clinical trial in the third quarter of 2020. In … [Read more...] about Altimmune and UAB partner to develop intranasal COVID-19 vaccine
Positive Phase 2 results for Verona’s ensifentrine MDI
Verona Pharma has announced that a Phase 2 trial of 5 dosage strengths of an MDI formulation of ensifentrine for the treatment of moderate to severe COPD demonstrated that all but the lowest dose of ensifentrine produced statistically significant and clinically meaningful improvement in lung function compared to placebo. The 40 COPD patients enrolled in the trial each … [Read more...] about Positive Phase 2 results for Verona’s ensifentrine MDI