ARS Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company's MAA for the European version of its Neffy epinephrine nasal spray. In April 2024, ARS announced that it had submitted a Day 180 response regarding the MAA for the nasal spray to CHMP. If approved, the European … [Read more...] about CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis
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Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to multiple sclerosis patients at Brigham and Women’s Hospital and for home use before initiating a Phase 2a trial of foralumab for … [Read more...] about Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
FDA approves Verona’s Ohtuvayre (nebulized ensifentrine) for the treatment of COPD
According to Verona Pharma, the FDA has approved the company's NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June 2023, and the FDA accepted the NDA for review in September 2023. The company says that Ohtuvayre will be available to patients in the US … [Read more...] about FDA approves Verona’s Ohtuvayre (nebulized ensifentrine) for the treatment of COPD
Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
Savara has announced that the Phase 3 IMPALA-2 trial of molgramostim nebulized recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with autoimmune pulmonary alveolar proteinosis (aPAP) met its primary endpoint, achieving statistically significant change in percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) … [Read more...] about Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
MHRA approves Type II variation to the Voke nicotine inhaler marketing authorization
OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for general sales as a nicotine replacement therapy. According to the Ayrtons web site, the company "has completely redeveloped the original … [Read more...] about MHRA approves Type II variation to the Voke nicotine inhaler marketing authorization
MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving an HbA1c level of less than 7% at 17 weeks compared to 17% of the usual care group. The company, which announced some data from the … [Read more...] about MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
Ritedose increases production capacity for inhalation products
CDMO Ritedose Corporation announced that it has added blow-fill-seal (BFS) capacity to its manufacturing facility in Columbia, SC, USA that will allow it to manufacture an additional 180 million unit doses of opthalmic and respiratory solutions. In addition to contract development and manufacturing, Ritedose manufactures its own generic inhalation solutions, including … [Read more...] about Ritedose increases production capacity for inhalation products
Proveris launches new Vereo NSx+SWC system for DDU testing of nasal sprays
Proveris Scientific has announced the official launch of the Vereo NSx+SWC (spray, weigh, and collect) nasal spray system, which it recently exhibited at RDD 2024 and which it calls "a pivotal advancement in product development and quality control workflows" with "walkaway automated functionality." The new system combines Proveris's Vereo NSx+ actuator technology with … [Read more...] about Proveris launches new Vereo NSx+SWC system for DDU testing of nasal sprays
Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company's AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint of change in pulmonary vascular resistance compared to placebo for any of the doses studied. The IMPAHCT trial was initiated in December … [Read more...] about Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Ethris announces $5 million in funding from the Gates Foundation and additional €3 million from Cipla to support continued development of ETH47 inhaled mRNA therapy
Ethris announced that the Gates Foundation is providing $5 million, and Cipla is investing an additional €3 million, that will be used to prepare for Phase 2 development of Ethris's ETH47 inhaled mRNA therapy. According to the company, the Gates Foundation funding "includes an equity investment component expected to close at the company’s next financing round." The … [Read more...] about Ethris announces $5 million in funding from the Gates Foundation and additional €3 million from Cipla to support continued development of ETH47 inhaled mRNA therapy