According to Beyond Air, the FDA has approved the company's LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is the first for the company, which is also developing LungFit iNO systems for the treatment of COVID-19 pneumonia, bronchiolitis, and … [Read more...] about FDA approves Beyond Air’s LungFit PH inhaled NO system for PPHN
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Cessatech announces plans for pivotal trial of CT001 intranasal analgesic
Danish startup Cessatech, a spin out from Rigshospitalet, announced that it has gotten the go-ahead for a pivotal trial of its CT001 analgesic nasal spray. Cessatech is developing CT001, a fixed dose combination of sufentanil and ketamine, for use in pediatric patients and has already completed dosing in a Phase 2 PK study of the nasal spray in children aged 1-17. … [Read more...] about Cessatech announces plans for pivotal trial of CT001 intranasal analgesic
DFE launches Lactohale 400 anhydrous inhalation grade lactose
DFE Pharma has announced the launch of a new product in its range of Lactohale inhalation grade lactose products; Lactohale 400 milled anhydrous lactose is described as a grade for formulations "where a relatively good flow with some cohesiveness is required." According to the company, the median particle size of Lactohale 400 is 100μm, and DFE Pharma will work with … [Read more...] about DFE launches Lactohale 400 anhydrous inhalation grade lactose
Orexo initiates Phase 1 trial of OX640 intranasal dry powder adrenaline
Orexo announced the initiation of a Phase 1 trial of its OX640 intranasal dry powder adrenaline, which the company is developing for emergency treatment of anaphylaxis. The OX640-001 study will compare several formulations of OX640 to intramuscular adrenaline in healthy volunteers. OX640 is based on Orexo's amorphOX particle engineering technology, which is also … [Read more...] about Orexo initiates Phase 1 trial of OX640 intranasal dry powder adrenaline
Receptor initiates Phase 1b/2a trial of RLS103 dry powder CBD in patients with SAD
Receptor Life Sciences said that a Phase 1b/2a trial of its RLS103 cannabidiol DPI in social anxiety disorder patients with acute anxiety has gotten underway. The trial is expected to enroll approximately 30 patients who will get either 3 mg of RLS103, 6 mg of RLS103, or an inhaled dry powder placebo prior to a public speaking challenge. The RLS103 formulation … [Read more...] about Receptor initiates Phase 1b/2a trial of RLS103 dry powder CBD in patients with SAD
Altamira’s Bentrio nasal spray gets 510(k) clearance
Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company said that it is in talks with "established OTC consumer health companies" regarding distribution of Bentrio in the US and elsewhere and … [Read more...] about Altamira’s Bentrio nasal spray gets 510(k) clearance
Phase 1b study of FluGen’s intranasal flu vaccine in older adults gets underway
FluGen said that the first subject has been dosed in a Phase 1b study of its M2SR intranasal live single replication flu vaccine and an intramuscular high dose inactivated vaccine (IIV) in adults aged 65 to 85 years. The study, which is funded by the US Department of Defense, will evaluate each of the vaccines separately, as well as the intranasal and IIV vaccines … [Read more...] about Phase 1b study of FluGen’s intranasal flu vaccine in older adults gets underway
H&T Presspart opens low-GWP MDI filling facility
Device maker H&T Presspart has announced the opening of a new laboratory scale facility at its Blackburn, UK Inhalation Product Technology Centre (IPTC) for filling metered dose inhalers with lower global warming potential (GWP) propellants, including both HFA 152a and HFO 1234ze. According to the company, which offers product development services and … [Read more...] about H&T Presspart opens low-GWP MDI filling facility
Padagis launches generic of Narcan naloxone nasal spray
Padagis, formerly Perrigo's generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the US since the FDA's initial approval of Narcan in 2015. Teva’s version of Narcan was approved by the FDA in April 2019 and was … [Read more...] about Padagis launches generic of Narcan naloxone nasal spray
Glenmark launches Indamet indacaterol / mometasone DPI for the treatment of asthma in India
Glenmark Pharmaceuticals has announced the launch of an inhaled dry powder fixed dose combination of indacaterol and mometasone furoate for the treatment of asthma which is being marketed under the name "Indamet". All three of the strengths offered include 150 mcg of indacaterol, plus either 80, 160, or 320 mcg of mometasone. Glenmark Group VP and Head, India … [Read more...] about Glenmark launches Indamet indacaterol / mometasone DPI for the treatment of asthma in India