Kimberly Shepard is Director, Respiratory Delivery, at Lonza You presented a workshop at RDD 2023 subtitled, “From small molecules to all molecules” -- can all biotherapeutics really be spray dried for inhalation? Besides being a catchy title, “From small molecules to all molecules” captures the essence of what’s going on right now in the field of pharmaceutical … [Read more...] about Lonza’s Kimberly Shepard answers questions about spray drying biologics for inhalation
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Orexo gets additional US patent covering OX640 epinephrine nasal powder
According to Orexo, the United States Patent and Trademark Office (USPTO) has granted US Patent No. 11,957,647 ("Pharmaceutical composition comprising adrenaline"), which covers Orexo's OX640 epinephrine nasal powder product. The USPTO previously issued US patent No. 11,737,980, which also provides protection for OX640, in August 2023. The FDA is currently … [Read more...] about Orexo gets additional US patent covering OX640 epinephrine nasal powder
Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Inhalation CDMO Vectura has partnered with Mundipharma to reformulate Flutiform fluticasone propionate / formoterol fumarate MDI using a lower global warming potential (LGWP) propellant, the companies announced. According to the announcement, the first step in the reformulation will be to identify which LGWP propellant will replace HFA-227 in the … [Read more...] about Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
According to inhaler monitor company Adherium, the FDA has cleared the Hailie Smartinhaler sensor for use with the Airsupra albuterol / budesonide MDI and with the Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI, both from AstraZeneca. The Hailie system is already approved for use with a number of different inhalers, including GSK's Ventolin, … [Read more...] about Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
Pulmocide announced that the Phase 2 OPERA-S study of PC945 inhaled opelconazole in lung transplant patients demonstrated that the inhalation suspension was generally safe and well tolerated, with no subjects needing to discontinue or reduce medications due to interactions with immunosuppressant drugs. Pulmocide is developing PC945, which has been granted orphan drug, … [Read more...] about Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
Silo Pharma announced that it will exercise an option for an exclusive worldwide license to develop SPC-14, an intranasal therapy for the treatment of Alzheimer’s disease, from Columbia University. Silo says that it expects the license agreement to be finalized by mid-2024 and that it plans to pursue the 505(b)(2) regulatory pathway. The company's pipeline also … [Read more...] about Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
Kexing Biopharm announced that has initiated a Phase 3 trial of human Interferon α1b inhalation solution, which the company is developing for the treatment of children with pneumonia or bronchiolitis associated with respiratory syncytial virus. According to Kexing, a Phase 1 trial of the inhalation solution was completed in October 2023 and demonstrated low systemic … [Read more...] about Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
Chiesi has announced the initiation of a Phase 3 safety study of CHF5993 beclometasone / formoterol / glycopyrronium HFA 152a MDI, an LGWP propellant version of Trimbow MDI, which uses HFA 134a as a propellant. In December 2019, Chiesi announced that it planned to bring an HFA 152a inhaler to market by the end of 2025. The Phase 3 trial will compare the HFA 152a … [Read more...] about Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed … [Read more...] about ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray