Nasal spray CDMO Summit Biosciences has nearly completed a $19 million expansion of its facility at the University of Kentucky Coldstream Research Campus that is expected to create 78 jobs, the state of Kentucky has announced. Following the expansion, which includes laboratory, warehouse, and manufacturing space, the facility will total 44,000 sq ft. The company, … [Read more...] about Summit Biosciences expansion nearing completion
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Galecto raises $64 million in preparation for potential approval of its inhaled galectin-3 inhibitor for IPF
Galecto said that it has completed a $64 million equity financing led by Soleus Capital that will be used to advance several candidates, including GB0139, a galectin-3 inhibitor DPI for the treatment of idiopathic pulmonary fibrosis (IPF). Specifically, the company said that funds will "support preparations for potential EU conditional approval of GB0139 in … [Read more...] about Galecto raises $64 million in preparation for potential approval of its inhaled galectin-3 inhibitor for IPF
UT Austin study concludes that TFF dry powder remdesivir is suitable as an inhaled therapy for COVID-19
TFF Pharmaceuticals is drawing attention to in vitro data published by researchers at the University of Texas Austin which found that thin film freezing "produces high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce … [Read more...] about UT Austin study concludes that TFF dry powder remdesivir is suitable as an inhaled therapy for COVID-19
Spirovant’s inhaled gene therapy for CF gets orphan drug and rare pediatric disease designations
The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences's SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective cystic fibrosis transmembrane conductance regulator (CFTR) genes and is meant for CF patients who are unable to … [Read more...] about Spirovant’s inhaled gene therapy for CF gets orphan drug and rare pediatric disease designations
Bharat Biotech and Precision Virologics license intranasal COVID-19 vaccine from Washington University in St. Louis
Bharat Biotech and Precision Virologics have acquired the rights to a single dose intranasal COVID-19 vaccine developed at the Washington University School of Medicine in St. Louis, the companies said. The agreement gives Precision Virologics rights to the chimpanzee adenovirus-vectored vaccine in the US, Europe, and Japan and gives Bharat distribution rights in the … [Read more...] about Bharat Biotech and Precision Virologics license intranasal COVID-19 vaccine from Washington University in St. Louis
Verona initiates Phase 3 trials of nebulized ensifentrine for COPD
Verona Pharma has announced the initiation of the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program to study the use of nebulized ensifentrine for the treatment of moderate to severe COPD. In July 2020, the company announced that it had raised approximately $200 million for Phase 3 development of the nebulized formulation for … [Read more...] about Verona initiates Phase 3 trials of nebulized ensifentrine for COPD
Neurelis announces clinical trial of Valtoco in epilepsy patients aged 2-5
Neurelis has announced plans to conduct a clinical trial of Valtoco diazepam nasal spray in children with epilepsy aged 2-5 and said that the company intends to file an sNDA to expand the use of Valtoco to include this population sometime in 2021. The FDA approved Valtoco for the treatment of seizure clusters in patients 6 years old and older in January 2020 and … [Read more...] about Neurelis announces clinical trial of Valtoco in epilepsy patients aged 2-5
Recordati gets marketing rights to ARS’s epinephrine nasal spray in 93 countries
Recordati has acquired marketing rights to ARS Pharmaceuticals' ARS-1 epinephrine nasal spray in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle East, and francophone African countries, the companies said. ARS will manufacture the nasal spray and supply it to Recordati. The deal includes an upfront payment plus milestones … [Read more...] about Recordati gets marketing rights to ARS’s epinephrine nasal spray in 93 countries
FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma's ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they "are committed to bringing this important product to the US market and remain confident in the submission." Hikma said that … [Read more...] about FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
Study shows Clement Clarke’s Clip-Tone device improves inhaler technique
Clement Clarke International is highlighting the results of a study done in partnership with Egypt's Beni-Suef University Research demonstrating that the company's Clip-Tone audible feedback device can improve MDI technique. The data were presented at the 2020 European Respiratory Society Congress. The Clip-Tone device attaches to the top of an MDI actuator and … [Read more...] about Study shows Clement Clarke’s Clip-Tone device improves inhaler technique