News
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Aptar said that the company has won a contract worth up to $6 million from the FDA for a study “designed to provide the FDA with information related to the formulation, manufacture, device design and… Read more . . .
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Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal… Read more . . .

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