According to Medical Developments International (MVP), Daiichi Sankyo will pay up to $32.5 million for the rights to distribute MVP's Penthrox methoxyflurane inhaler in China, Vietnam, and Thailand. The deal includes $15 million up front plus sales milestones. MVP will pay up to $10 million toward acquiring marketing approval in China, will own the drug import … [Read more...] about Daiichi Sankyo to distribute Penthrox methoxyflurane inhaler in China
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FDA clarifies regulatory pathway for CounterAct’s naloxone nasal spray cap
According to California-based start-up CounterAct, the FDA has approved of the company's approach regarding potential approval of its naloxone nasal spray cap. The CounterAct cap is a plastic device that snaps onto the top of a prescription bottle. In the event of an opiate overdose, the top of the cap is removed, allowing a spray nozzle to fold out to deliver a dose … [Read more...] about FDA clarifies regulatory pathway for CounterAct’s naloxone nasal spray cap
Micro-Sphere adds DPI capsule filling capacity
Swiss CDMO Micro-Sphere has announced the addition of new DPI capsule filling capacity with a new MG2 Tekna filling machine in a dedicated, humidity-controlled cleanroom at its facility near Lugano. The company also has added a MultiNETT 100% weight control system. Earlier this year, the company announced that the facility, which was recently expanded, had … [Read more...] about Micro-Sphere adds DPI capsule filling capacity
Aptar Pharma announces launch of PureHale device
Aptar Pharma has announced that it will officially launch its new PureHale aerosol device at CPhI Worldwide. Purehale, a bag-on-valve "nebulizer-like device," is a finalist for the CPhI Pharma Awards in the drug delivery device category. Although the blurb for PureHale on the CPhI page says, "Delivering portable respiratory relief, revolutionizing the nebulizer … [Read more...] about Aptar Pharma announces launch of PureHale device
FDA approves Arikayce amikacin liposome inhalation suspension (ALIS)
The FDA has approved Insmed's amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients. Arikayce, which Insmed had recently been referring to as ALIS, is delivered using PARI's Lamira nebulizer system. According to Insmed, Arikayce will … [Read more...] about FDA approves Arikayce amikacin liposome inhalation suspension (ALIS)
United Therapeutics licenses inhaled IPF drug from Samumed
United Therapeutics will pay Samumed $10 million up front and up to $340 million in milestones, plus royalties, for North American rights to Samumed's SM04646, a Wnt signaling pathway inhibitor that in in Phase 1 development for the treatment of idiopathic pulmonary fibrosis (IPF). A United Therapeutics subsidiary, Lung Biotechnology PBC, will take over and pay … [Read more...] about United Therapeutics licenses inhaled IPF drug from Samumed
Dance Biopharm appoints Anne Whitaker as CEO
Inhaled insulin developer Dance Biopharm has announced the appointment of former Novoclem Pharmaceuticals President and CEO Anne Whitaker as a Director and CEO as of October 1st, 2018. In addition to founding and heading up inhaled drug developer Novoclem, Whitaker has also held executive positions at Bausch Health, Synta Pharmaceuticals, Sanofi, and GSK. Earlier … [Read more...] about Dance Biopharm appoints Anne Whitaker as CEO
TFF Pharmaceuticals gets European patent for particle technology
DPI developer TFF Pharmaceuticals has received a communication from the European Patent Office (EPO) in regards to its patent application No. 08771657.7 “Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing,” giving notice of the EPO's intention to grant a patent. TFF Pharmaceuticals CEO Glenn Mattes commented, “We are very pleased to … [Read more...] about TFF Pharmaceuticals gets European patent for particle technology
Neurelis submits NDA for Valtoco diazepam nasal spray
According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in December 2016. Neurelis President and CEO Craig … [Read more...] about Neurelis submits NDA for Valtoco diazepam nasal spray
Senzer reports data from PK study of inhaled dronabinol
According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer's Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol oral dronabinol, with the inhaled dose reaching Cmax in 2 minutes compared to almost 2 hours for the oral dose. Insys acquired US rights to the Voke inhaler … [Read more...] about Senzer reports data from PK study of inhaled dronabinol