Merz Therapeutics announced that it has acquired Inbrija inhaled dry powder levodopa from Acorda Therapeutics, which declared bankruptcy earlier this year. Merz had served as a "stalking horse bidder" for the Acorda assets, which also included Fampyra. Inbrija has been approved treatment of OFF episodes in Parkinson’s disease patients since December 2018 in the US … [Read more...] about Merz Therapeutics acquires Inbrija levodopa DPI from Acorda
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Vistagen gets additional patents covering PH80 pherine nasal spray for the treatment of migraine
Vistagen announced that it has been granted patents related to the use of PH80 pherine nasal spray for the treatment of migraine in Australia, Hong Kong, Japan, and Mexico. All four of the new patents should cover PH80 through 2040. The USPTO granted a patent covering the use of PH80 for migraine in 2022, and the EPO followed in 2023. PH80 intranasal … [Read more...] about Vistagen gets additional patents covering PH80 pherine nasal spray for the treatment of migraine
Nocion announces appointments of Catherine Bonuccelli and Joan Shaw
Nocion Therapeutics, whose taplucainium (NTX-1175) DPI is in Phase 2 development for the treatment of chronic cough, has announced the appointments of two former Bellus Health executives, naming Catherine Bonuccelli to the scientific advisory board and Joan Shaw as Senior VP, Clinical Operations. Both were involved in the clinical development of Bellus' camlipixant … [Read more...] about Nocion announces appointments of Catherine Bonuccelli and Joan Shaw
Cardiff Scintigraphics names John Pritchard as Chairman of the Board
Cardiff Scintigraphics, has announced the appointment of OINDP expert John Pritchard as the company's Chairman of the Board, succeeding David Owen. The news comes soon after Cardiff Scintigraphics, the parent company of inhalation CRO i2c Pharma Services, named Andrew Brown as CEO, succeeding Glyn Taylor. Pritchard, the 2018 winner of the Charles G. Thiel Award for … [Read more...] about Cardiff Scintigraphics names John Pritchard as Chairman of the Board
1nhaler announces board appointments
Disposable dry powder inhaler developer 1nhaler has announced the appointment of former AstraZeneca VP Jane Gaddum as Board Chair and non-executive director and former GSK VP Gordon Muirhead as a non-executive director. Gaddum was AstraZeneca VP of Global Marketing for Emerging Respiratory and Inflammation from 1997 to 2013, according to her LinkedIn profile. … [Read more...] about 1nhaler announces board appointments
CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis
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
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