OINDP specialist contract developer Kenox Pharmaceuticals announced that it has added a clean room for small scale manufacturing of non-sterile nasal sprays and dry powders for use in pre-clinical development. The company, which is located in Princeton, NJ, USA, said that it is also in the process of adding Phase 1 and 2 clinical scale GMP manufacturing capabilities … [Read more...] about Kenox Pharmaceuticals adds small scale GMP capability for OINDPs
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InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu
InvisiShield Technologies said that it will speed up its H5N1 / Pan-influenza intranasal antibodies development program in response to recent outbreaks of H5N1 avian flu in mammals. The company says that it can move quickly into clinical development because it previously held successful pre-IND meetings with the FDA regarding its IS101 intranasal antibody fusion … [Read more...] about InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu
Copley Scientific introduces new Powder Testing Workstation PTW and Powder Testing Assistant PTA 100i
OINDP testing specialists Copley Scientific have announced the launch of the new Powder Testing Workstation PTW for flowability testing as well as the Powder Testing Assistant PTA 100i. The customizable PTW system allows the user to select various modules for angle of repose, flow through an orifice, and bulk density testing of dry powders. The PTA 100i offers … [Read more...] about Copley Scientific introduces new Powder Testing Workstation PTW and Powder Testing Assistant PTA 100i
Beckley announces results of Phase 2a trial of BPL-003 intranasal synthetic 5-MeO-DMT in alcohol use disorder
Beckley Psytech announced that a Phase 2a study of BPL-003 intranasal synthetic 5-MeO-DMT in people with alcohol use disorder demonstrated "meaningful and sustained reductions in alcohol use" for as long as 3 months post dose, with no serious or severe adverse events. The study, which was primarily designed to evaluate safety, enrolled 12 subjects with … [Read more...] about Beckley announces results of Phase 2a trial of BPL-003 intranasal synthetic 5-MeO-DMT in alcohol use disorder
FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The trial, which will evaluate inhaled and intranasal administration of the vaccine, will be conducted by the NIH's National Institute of Allergy and Infectious … [Read more...] about FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
Nevada-based Corstasis Therapeutics announced that the FDA has accepted the company's NDA for RSQ-777 bumetanide nasal spray, a diuretic for the treatment of edema associated with congestive heart failure, kidney disease, and liver disease. The agency assigned a PDUFA target date of September 14, 2025. Corstasis CEO Benjamin Esque commented, “We are pleased … [Read more...] about Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial
North Carolina-based Belhaven Biopharma announced that it has closed a funding round that raised $11 million for continued development of the company's Nasdepi intranasal dry powder epinephrine for the treatment of anaphylaxis. The company said that the funds will support the completion of clinical development and preparations for an NDA submission. Belhaven also … [Read more...] about Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial
KAER Bio launches AeroPulsR high dose delivery system for critical care use
KAER Biotherapeutics has announced the launch of the AeroPulsR aerosol device for delivery of high doses of aqueous aerosols in critical care settings. According to KAER, the AeroPulsR can deliver liquids of viscosities up to 50 cP as aerosols with particle sizes in the 2-4 μm range. The device also can deliver aerosols in continuous, periodic, or spontaneous … [Read more...] about KAER Bio launches AeroPulsR high dose delivery system for critical care use
Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections
Vast Therapeutics announced that the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has awarded the company $1,988,594 to support a 2-year project titled "Nebulized ALX1 as a treatment for Pseudomonas aeruginosa infections in bronchiectasis patients." According to the company's web site, "ALX1 contains a water … [Read more...] about Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections
FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression
According to Johnson & Johnson, the FDA has approved the company's sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of major depressive disorder in adults who have not responded adequately to a minimum of two oral antidepressants. Administration of Spravato is available only in healthcare settings under a REMS program. Spravato has … [Read more...] about FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression