CDMO Kindeva Drug Delivery has announced an expansion at its facility in Loughborough, UK to add dedicated laboratory space for analytical laboratory services. According to the company, the new Loughborough facility will double its lab space in the UK. In January 2024, Kindeva announced that it was launching an analytical laboratory services business and was opening a … [Read more...] about Kindeva announces additional expansion of its Loughborough UK facility
News
Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Earlier this year, the company said that … [Read more...] about Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
Cardiff Scintigraphics / i2c name Andrew Brown as CEO
Cardiff Scintigraphics, the parent company of inhalation CRO i2c Pharma Services, has named former OBG Pharmaceuticals Chief Scientific Officer Andrew Brown as CEO, succeeding Glyn Taylor, who will continue part time as Chief Scientific Officer. Brown was most recently Chief Scientific Officer and Operations Director of OBG subsidiary Noveayr Therapeutics, which … [Read more...] about Cardiff Scintigraphics / i2c name Andrew Brown as CEO
FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray
Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a Refuse to File letter in December 2023. The company re-submitted the NDA in March 2024. Milestone … [Read more...] about FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray
FDA grants Fast Track designation to SpliSense’s SPL84 inhaled antisense oligonucleotide for CF
According to SpliSense, the FDA has granted Fast Track designation to the company's SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis. SPL84 had already received Orphan Drug designation from both the FDA and the EMA. Earlier this year, the FDA cleared an IND for a Phase 2 trial of SPL84 in patients with cystic fibrosis associated with the … [Read more...] about FDA grants Fast Track designation to SpliSense’s SPL84 inhaled antisense oligonucleotide for CF
MannKind acquires Pulmatrix R&D facility and the companies cross-license inhalation technology
MannKind Corporation will assume the lease for a Pulmatrix research laboratory located in Bedford, MA, USA, and Pulmatrix will transfer the facility, including all laboratory equipment, to MannKind, the companies said. MannKind says that it plans to hire some of the Pulmatrix personnel who have been working at the lab. In addition, MannKind will acquire the rights … [Read more...] about MannKind acquires Pulmatrix R&D facility and the companies cross-license inhalation technology
RDD 2024 highlighted an industry in transition
RDD 2024, which took place May 5-9 in Tucson, AZ, USA, brought together more than 530 delegates and 70 exhibitors for a meeting that highlighted a number of transitions taking place in the development of OINDPs. Compared to past meetings, the 2024 edition of Respiratory Drug Delivery featured a large proportion of the presentations, posters, and exhibitors … [Read more...] about RDD 2024 highlighted an industry in transition
Gerresheimer adds capacity for inhaler manufacturing at US facility
Gerresheimer has announced a $180 million, 194,000 sq ft expansion of its device manufacturing facilities near Atlanta, GA, USA. The company says that the expansion will create more than 400 new jobs at its Georgia facilities, where it manufactures medical devices including inhalers, bringing its total workforce in Georgia to almost 700. According to Gerresheimer, … [Read more...] about Gerresheimer adds capacity for inhaler manufacturing at US facility
Ferrer gets additional distribution rights to Tyvaso treprostinil inhalation solution
Ferrer has announced that its 2022 agreement with United Therapeutics for distribution rights to Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) outside of the US, Canada, Israel, Japan, and China has been modified to add two more indications: idiopathic pulmonary ibrosis (IPF) and … [Read more...] about Ferrer gets additional distribution rights to Tyvaso treprostinil inhalation solution
Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain
According to Rigshospitalet spin-out Cessatech, the company has initiated a Phase 3 trial of its CT001 sufentanil / ketamine nasal spray in children seen in the emergency department with moderate to severe pain. In July 2022, Cessatech announced plans for the 0205 trial of CT001 in adult patients following extraction of wisdom teeth, and the company reported results … [Read more...] about Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain