News
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A Florida-based company called MicroNeb and a privately-held biopharma company called US Precision Medicine (USPM) say that they have signed a memorandum of understanding allowing USPM to use MicroNeb nebulizer technology for delivery of an… Read more . . .
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The FDA has granted Fast Track designation to Tiziana Life Sciences’ intranasal foralumab, an anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS), the company said. Tiziana is also developing intranasal… Read more . . .
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According to Emergent BioSolutions, the shelf life for newly manufactured Narcan naloxone nasal spray has been extended to 48 months; the previous shelf life was 36 months. Narcan has been approved for the reversal of opioid… Read more . . .
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Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved… Read more . . .
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Australian pharma company De Motu Cordis (DMC), which is developing an epinephrine DPI for the treatment of anaphylaxis, announced that it has contracted with Catalent for product assembly, expanding a November 2022 deal with the… Read more . . .
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The FDA has issued a complete response letter to Orexo’s NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the… Read more . . .
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According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company’s NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1… Read more . . .
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Particle characterization specialist Micromeritics Instrument Corporation is set to be acquired by Spectris subsidiary Malvern Panalytical, the companies have announced. According to Spectris, the deal includes a $630 million payment up front and up to… Read more . . .
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CDMO Kindeva Drug Delivery announced the completion of an FDA inspection at the company’s new laboratory facility in Woodbury, MN, USA and said that the site will continue with routine cGMP audits in the future.… Read more . . .
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UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
The University of Texas Medical Branch announced publication of an article in Science Translational Medicine by UTMB researchers who are developing an intranasal toxic tau conformation–specific monoclonal antibody-2 (TTCM2) to prevent the accumulation of tau protein… Read more . . .
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