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
Business
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
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
Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Celon Pharma has disclosed a deal in which it will invest $20 million over 2 years, and Tang Capital will invest $10 million over that same period, in a new US-based company called Novohale Therapeutics that will initiate Phase 3 development of Celon's Falkieri esketamine DPI for the treatment of bipolar depression. Celon's marketed products include the Salmex … [Read more...] about Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
DPI developers Iconovo have announced plans to develop inhaled GLP-1 receptor agonists for the treatment of obesity and, potentially, related metabolic diseases. The company says that it plans to conduct preclinical proof-of-concept studies itself and then will look to out-license the inhalers. As part of its efforts in this area, the company said that it had filed "a … [Read more...] about Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
Bespak and DevPro developing HFO-1234ze albuterol MDI
CDMO Bespak and DevPro Biopharma have revealed their partnership on development of DevPro's DP007 albuterol MDI, which is formulated with Honeywell's Solstice Air HFO-1234ze(E) propellant. According to the companies, DP007 is expected to provide a lower global warming potential alternative to Ventolin HFA MDI. Bespak and DevPro say that they plan to initiate clinical … [Read more...] about Bespak and DevPro developing HFO-1234ze albuterol MDI
Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer's seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory … [Read more...] about Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company's MAA for Neffy epinephrine nasal spray to the EMA's Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal … [Read more...] about ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency's acceptance of the ANDA in March 2023. The nasal spray is a generic version of Narcan, which was approved for OTC sales later in March … [Read more...] about FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”
Firebrick Pharma announced that it has launched Nasodine povidone-iodine nasal spray in the US via direct sales through a web site. The company said that it will not make any therapeutic claims so that the nasal spray will not require FDA approval. For now, Firebrick said, Nasodine will be marketed as a "nasal hygiene" product and will be available only on a US web … [Read more...] about Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”