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 foralumab for the treatment of Alzheimer's disease and has announced plans to develop the nasal … [Read more...] about Tiziana’s intranasal foralumab for the treatment of non-active secondary progressive MS gets Fast Track designation
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Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
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 overdose in Canada since October 2016. Emergent Senior VP, Head of Products Business, Paul Williams commented, “Helping to save lives from … [Read more...] about Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
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 an NDA submitted by J&J subsidiary Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) for the use of Spravato with an oral … [Read more...] about J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
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 CDMO that covered formulation and manufacturing. The extension of the deal will provide manufacturing and assembly services through a … [Read more...] about De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
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 agency rejected its first application due to concerns about the packaging process. The NDA had been initially submitted in early 2023. The FDA accepted the … [Read more...] about FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
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 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The … [Read more...] about FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
Micromeritics to be acquired by Malvern Panalytical
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 an additional $53 million on the achievement of 2024/25 performance goals. Micromeritics' products include the … [Read more...] about Micromeritics to be acquired by Malvern Panalytical
FDA completes inspection of new Kindeva analytical services facility in Minnesota
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. The company announced the opening of the Woodbury facility, home to a new analytical services business unit, in January 2024. According to Kindeva, the FDA … [Read more...] about FDA completes inspection of new Kindeva analytical services facility in Minnesota
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 in the brain. The article describes successful intranasal delivery of TTCM2 loaded in micelles to the … [Read more...] about UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
Phase 1 trial FluGen’s M2SR intranasal flu vaccine in elderly demonstrated benefit of coadministration
FluGen announced that it has published data from a 2022 Phase 1 trial of its M2SR intranasal flu vaccine coadministered with Fluzone high dose intramuscular inactivated influenza vaccine (IIV) in people aged 65 to 85 in Lancet Infectious Diseases. According to the company, the study, which was funded by the US Department of Defense, demonstrated that elderly people … [Read more...] about Phase 1 trial FluGen’s M2SR intranasal flu vaccine in elderly demonstrated benefit of coadministration