Liquidia Corporation said that a new agreement will supersede its 2012 license agreement with GSK that gave GSK exclusive rights to develop certain inhaled formulations based on Liquidia's PRINT particle engineering technology. In 2015, GSK exercised an option giving it exclusive worldwide rights to develop PRINT formulations of inhaled therapies, with the exception … [Read more...] about GSK gives up exclusive license for use of Liquidia’s PRINT particle technology for inhaled formulations
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Orexo says it will have to resubmit NDA for OX124 intranasal naloxone
Orexo announced that the FDA will require the company to resubmit its NDA for OX124 intranasal dry powder naloxone due to "unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124." The company had announced its submission of the NDA in February 2023. According to Orexo, the agency's only request … [Read more...] about Orexo says it will have to resubmit NDA for OX124 intranasal naloxone
PureIMS gets investment to fund development of its Levodopa Cyclops DPI
DPI developer PureIMS announced that it has closed an investment round that included Boost-UP Foundation, CardusoCapital, IMDS Medical Devices, and LinesBridge Pharma Group, with funds intended mostly to support development of a levodopa DPI based on the company's Cyclops pre-filled single use dry powder inhaler. The amount of the new investment was not specified. … [Read more...] about PureIMS gets investment to fund development of its Levodopa Cyclops DPI
Renovion’s ARINA-1 inhaled mucolytic gets Fast Track designation for prevention of BOS following lung transplant
The FDA has granted Fast Track designation to Renovion's ARINA-1 nebulized mucolytic for the prevention of bronchiolitis obliterans syndrome in patients who have had a bilateral lung transplant, which will allow the company to take advantage of a rolling NDA submission, Renovion said. In August 2022, the company announced that it had received a Study May Proceed … [Read more...] about Renovion’s ARINA-1 inhaled mucolytic gets Fast Track designation for prevention of BOS following lung transplant
FDA advisory committee meeting scheduled for Neffy epinephrine nasal spray
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has scheduled a meeting on May 11, 2023 to review the ARS Pharmaceuticals' NDA for Neffy intranasal epinephrine for the treatment of anaphylaxis and other Type 1 allergic reactions. The FDA accepted the NDA for review in October 2022. Public comments may be submitted up to April 27 for delivery to the … [Read more...] about FDA advisory committee meeting scheduled for Neffy epinephrine nasal spray
FDA approves Narcan for over-the-counter sales
The FDA has approved Emergent Biosolutions' sNDA for OTC sales of Narcan naloxone nasal spray, 4 mg, for reversal of opioid overdose. Narcan was first approved for prescription use in the US in 2015. The agency accepted the sNDA for review in December 2022, and the Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees voted unanimously … [Read more...] about FDA approves Narcan for over-the-counter sales
Tiziana announces plans for Phase 2 trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis
Tiziana Life Sciences says that after receiving feedback from the FDA following a Type C meeting, the company plans to move forward with a Phase 2 trial of intranasal foralumab, a human anti-CD3 mAb, in patients with non-active secondary progressive multiple sclerosis. In September 2019, Tiziana announced results from its Phase 1 trial of intranasal foralumab. Since … [Read more...] about Tiziana announces plans for Phase 2 trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis
MannKind names Lauren Sabella as Executive VP, COO
MannKind Corporation has named former Acorda Therapeutics COO Lauren Sabella as Executive VP, Chief Operating Officer. Sabella's experience includes 12 years at Acorda, first as Chief Commercial Officer and then as COO; she previously served in a number of roles at Boehringer Ingelheim, including as Executive Director of Marketing for the Respiratory Franchise and as … [Read more...] about MannKind names Lauren Sabella as Executive VP, COO
Avalyn reports data from Phase 1b study of AP01 inhaled pirfenidone in IPF patients
Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse events were mild-to-moderate and less frequent than side effects associated with oral pirfenidone. They also reported that … [Read more...] about Avalyn reports data from Phase 1b study of AP01 inhaled pirfenidone in IPF patients
In Memoriam: Charles G. Thiel
Charles G. Thiel, one of the most influential scientists working in respiratory drug delivery over the past 7 decades, passed away on March 10, 2023 at the age of 94. In 1956, Thiel and co-workers at Riker Laboratories developed the first pressurized metered dose inhaler for delivery of medication to the lungs. Following the 1970 acquisition of Riker by 3M (now … [Read more...] about In Memoriam: Charles G. Thiel