The 34th iteration of the Drug Delivery to the Lungs (DDL) Conference, DDL 2023, drew approximately 930 OINDP specialists to the Edinburgh International Conference Centre (EICC) December 6 - 8, with more than 100 additional attendees joining online. The conference also drew support from 115 sponsors, including almost 20 new companies exhibiting for the first time. … [Read more...] about DDL 2023 highlighted novel technologies
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Favorex to market Marinomed’s Carragelose nasal spray in Thailand, Malaysia, Myanmar, and the Philippines
Marinomed Biotech announced that DKSH subsidiary Favorex has acquired commercialization rights to Marinomed's Carragelose iota-carrageenan nasal spray for Thailand, Malaysia, Myanmar, and the Philippines. Earlier this year, Carragelose nasal spray was approved in Mexico, where it will be marketed as "Barlo" by M8. Perrigo markets the nasal spray in a number of … [Read more...] about Favorex to market Marinomed’s Carragelose nasal spray in Thailand, Malaysia, Myanmar, and the Philippines
Agomab announces initiation of Phase 1 trial of AGMB-447 inhaled ALK5 inhibitor
Agomab Therapeutics announced that it has initiated a Phase 1 trial of its AGMB-447 inhaled ALK5 inhibitor that is expected to enroll 76 healthy subjects and idiopathic pulmonary fibrosis (IPF) patients. According to Agomab, the IPF patients will receive AGMB-447 over a two-week period following a SAD/MAD portion of the study in healthy subjects. Agomab Chief … [Read more...] about Agomab announces initiation of Phase 1 trial of AGMB-447 inhaled ALK5 inhibitor
MDI Plus launches MDI carton that doubles as a spacer
Irish start-up MDI Plus has announced the availability of its novel metered dose inhaler carton, which can be used as a spacer. The carton/spacer includes holes in each end of the cardboard box, with an opening on one end shaped to accommodate the inhaler mouthpiece and an opening on the other end for inhalation. According to the company's web site, the carton can be … [Read more...] about MDI Plus launches MDI carton that doubles as a spacer
Oz-UK adds manufacturing line for MDIs with LGWP propellants
CRO Oz-UK has announced that it is installing a new manufacturing line for metered dose inhalers that use LGWP propellants and expects the new line to be in operation by July 2024. According to the company, the line will be able to handle both HFO-1234ze and HFA-152a solution and suspension formulations, with batch sizes of 2.5 to 10 kg. In addition to a recent … [Read more...] about Oz-UK adds manufacturing line for MDIs with LGWP propellants
Aptar Pharma opens new manufacturing facility in Mumbai
Aptar Pharma has announced the official opening of its new 7,000 sq m manufacturing facility in Mumbai, India. Aptar has been manufacturing MDI valves and pumps at the site since 2012. According to Aptar, the capabilities there "have now been expanded to offer more innovative product solutions and ensure increased manufacturing capacity to pharma customers in South … [Read more...] about Aptar Pharma opens new manufacturing facility in Mumbai
FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis
The FDA has extended the review period for Optinose's sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved by the FDA in 2017 for the treatment of nasal polyps. The agency originally accepted the sNDA in May 2023 and set a PDUFA goal … [Read more...] about FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis
Recipharm announces appointment of Simon Gardner as Business Development Specialist, partnership with Oz-UK on LGWP MDIs
CDMO Recipharm announced that it has hired former Koura Global Business Development Director Simon Gardner as Business Development Specialist for pMDIs to assist customers with the transition to LGWP propellants. Recipharm President, Advanced Delivery Systems, Chris Hirst commented, "Vital to a successful transition for our customers is having access to a team of … [Read more...] about Recipharm announces appointment of Simon Gardner as Business Development Specialist, partnership with Oz-UK on LGWP MDIs
Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine
Nasus Pharma said that in a second PK study of FMXIN002 intranasal dry powder epinephrine, 91% of subjects who received a 4 mg dose of the nasal formulation reached the clinical threshold for plasma exposure at 6 minutes post dose compared to 51% who received a dose of epinephrine from an EpiPen. The company reported results from the initial PK study in June 2021. … [Read more...] about Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine
Kindeva and Koura partner on conversion of existing MDI to HFA 152a
Kindeva Drug Delivery and Koura Global parent company Orbia Advance Corporation announced that they have partnered to convert a currently marketed metered dose inhaler to use Koura's HFA 152a (Zephex 152a), a lower global warming potential (LGWP) propellant. According to the announcement, the collaboration "aims to facilitate conversion of pMDI products to the … [Read more...] about Kindeva and Koura partner on conversion of existing MDI to HFA 152a