The annual Drug Delivery to the Lungs meeting returns to the Edinburgh International Conference Centre (EICC) December 6-8. DDL 2022 attracted a total of more than 1,000 delegates in person and online, and DDL 2023 is also expected to draw a large crowd, says organizing committee member Michelle Dawson. For the first time, DDL will take over the entire EICC, providing … [Read more...] about Previewing DDL 2023
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Gossamer Bio names Rainer Zimmermann as VP of Medical Affairs
Gossamer Bio, which is developing its seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH), has announced the appointment of Rainer Zimmermann as VP of Medical Affairs. Zimmermann was most recently Global Medical Leader, Pulmonary Hypertension, at Janssen. Prior to Johnson & Johnson, Zimmermann served as Global Medical Lead, PH Franchise, at … [Read more...] about Gossamer Bio names Rainer Zimmermann as VP of Medical Affairs
Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19
According to Codagenix, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide up to $389 million to support a Phase 2b trial of CoviLiv live attenduated intranasal vaccine as a booster. Under the contract, the first tranche provided by BARDA will be $10 million. Codagenix is developing CoviLiv in … [Read more...] about Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19
Pneumagen says Phase 2 challenge study of Neumifil antiviral nasal spray against influenza met primary and secondary endpoints
Pneumagen announced that a Phase 2 challenge study Neumifil multivalent carbohydrate binding module (mCBM) nasal spray against influenza met its primary endpoints, demonstrating statistically significant reductions in the rate of infection and in symptom severity compared to placebo. The initiation of the challenge study was announced in August 2022. The company … [Read more...] about Pneumagen says Phase 2 challenge study of Neumifil antiviral nasal spray against influenza met primary and secondary endpoints
FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing "Insufficient information to assess risks to human subjects." The company said that it is waiting to learn more details from the FDA about the reasons for the clinical … [Read more...] about FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
Avalyn Pharma raises $175 million for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib
Avalyn Pharma announced that an oversubscribed Series C financing brought in $175 million that the company will use for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib for the treatment of pulmonary fibrosis. Earlier this year, the company reported data from a Phase 1b trial of nebulized AP01 in patients with idiopathic pulmonary fibrosis … [Read more...] about Avalyn Pharma raises $175 million for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib
CF Foundation to provide an additional $9 million for development of Arcturus’ ARCT-032 inhaled mRNA therapy
The Cystic Fibrosis Foundation announced that it has agreed to provide an additional $9 million in funding for development of Arcturus Therapeutics' ARCT-032 inhaled mRNA therapy for the treatment of CF. The CF Foundation said that it has already provided $15.6 million for development of ARCT-032, which is based on Arcturus' LUNAR lipid nanoparticle delivery platform. … [Read more...] about CF Foundation to provide an additional $9 million for development of Arcturus’ ARCT-032 inhaled mRNA therapy
FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review
According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender submitted the NDA in July 2023. The company said that the FDA granted priority review at the request of the US Navy. Defender President and CEO … [Read more...] about FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review
FDA sets PDUFA date for Liquidia’s sNDA to add PH-ILD indication for Yutrepia treprostinil DPI
Liquidia Corporation said that the FDA has accepted its sNDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication for Yutrepia treprostinil inhalation powder without requiring any additional studies and has set the PDUFA goal date as January 24, 2024. The FDA tentatively approved Yutrepia for the treatment of … [Read more...] about FDA sets PDUFA date for Liquidia’s sNDA to add PH-ILD indication for Yutrepia treprostinil DPI
Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT
Krystal Biotech said that the FDA has cleared an IND for KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin deficiency, and the company said that it plans to initiate a Phase 1 trial in early 2024. According to Krystal, the study will evaluate 3 ascending doses of KB408 in adult patients with AAT deficiency who have a PI*ZZ genotype. KB408 is … [Read more...] about Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT