Soon after the FDA granted temporary approval to Liquidia's sNDA for Yutrepia treprostinil DPI, the company announced that it has filed a lawsuit challenging the FDA's grant of 3-year new clinical investigation exclusivity to United Therapeutics' Tyvaso treprostinil DPI, which is standing in the way of final approval of Yutrepia. Exclusivity for Tyvaso DPI is … [Read more...] about Liquidia files suit to challenge FDA’s grant of exclusivity to Tyvaso DPI in ongoing litigation over Yutrepia DPI approval
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Pharma Nordic acquires Swedish and Danish rights to Altamira’s Bentrio bentonite-based nasal spray
Pharma Nordic has expanded its distribution agreement with Altamira Medica for Bentrio nasal spray, adding Sweden and Denmark, the companies announced. Bentrio is an OTC bentonite-based nasal spray gel marketed for the prevention and treatment of allergic rhinitis. In July 2023, Pharma Nordic acquired the distribution rights for Bentrio in Norway, and the company … [Read more...] about Pharma Nordic acquires Swedish and Danish rights to Altamira’s Bentrio bentonite-based nasal spray
Proveca acquires global rights to Cessatech’s CT001 sufentanil / ketamine nasal spray
Cessatech and pediatric medicines specialist Proveca have announced a deal that gives Proveca global commercialization rights to Cessatech's CT001 sufentanil / ketamine analgesic nasal spray. Earlier this year, Cessatech initiated a Phase 3 trial of CT001 in children with moderate-to-severe pain under care in the emergency department. According to the … [Read more...] about Proveca acquires global rights to Cessatech’s CT001 sufentanil / ketamine nasal spray
De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
Australian pharma company De Motu Cordis (DMC), which is developing an epinephrine DPI for the treatment of anaphylaxis, announced that it has contracted with Catalent for product assembly, expanding a November 2022 deal with the CDMO that covered formulation and manufacturing. The extension of the deal will provide manufacturing and assembly services through a … [Read more...] about De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
Merz Therapeutics acquires Inbrija levodopa DPI from Acorda
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
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
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
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
BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced that it has awarded approximately $40 million to CyanVac and approximately $34 million to CastleVax to support Phase 2b clinical trials of the companies' intranasal COVID-19 vaccine candidates. Each of the Phase 2b trials will … [Read more...] about BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
Firebrick launches Nasodine nasal spray in Singapore
Firebrick Pharma, which recently launched its Nasodine povidone-iodine nasal spray in the US as a "nasal hygiene" product, has now announced the launch of Nasodine in Singapore as a germicidal product for protection against infection. As in the US, the nasal spray will now be available to consumers in Singapore via a web site, though Firebrick says that it may be able … [Read more...] about Firebrick launches Nasodine nasal spray in Singapore