Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company's Adrenalin epinephrine for injection. As a result of the potential for confusion, Endo said, "FDA has determined the product to be misbranded … [Read more...] about Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded
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Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium
Aridis Pharmaceuticals said that "an undisclosed pharmaceutical company" has agreed to pay $6.5 million plus annual royalty payments for Aridis' AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis. Aridis said that it expects to receive 50% of the upfront payment by the end of the first quarter of 2025 and the other … [Read more...] about Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium
Appeals court upholds ruling requiring delisting of Teva ProAir HFA device patents from Orange Book
The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA's Orange Book. In the decision issued on December 20, 2024, the appeals court says, "to qualify for listing, a patent must claim at least what made the product approvable as a drug in the … [Read more...] about Appeals court upholds ruling requiring delisting of Teva ProAir HFA device patents from Orange Book
DDL 2024 in review
DDL 2024 drew the largest crowd ever in the 35-year history of the Drug Delivery to the Lung (DDL), with more than 100 OINDP experts attending online and approximately 1,000 attending in person at the Edinburgh International Conference Centre. DDL celebrated its anniversary with a gala dinner, timely podium and poster presentations, and a sold-out exhibition. Hot … [Read more...] about DDL 2024 in review
Savara initiates rolling BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
Savara announced that it has initiated a rolling biologics license application submission for its Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company said that it will request priority review of the application when the submission is complete, which is expected in the first quarter of 2025. … [Read more...] about Savara initiates rolling BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
PureIMS’s Colistin Cyclops DPI gets orphan designation from both the EMA and FDA
According to PureIMS, both the EMA and FDA have recently granted orphan drug designation to the company's Colistin Cyclops dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Colistin Cyclops is currently in Phase 1 development and is available in the Netherlands for the treatment of pulmonary P. aeruginosa infections as a … [Read more...] about PureIMS’s Colistin Cyclops DPI gets orphan designation from both the EMA and FDA
Orexo and Abera partner on development of intranasal dry powder vaccines
Intranasal drug developer Orexo and Swedish vaccine developer Abera Bioscience have announced that they will collaborate on development of intranasal dry powder vaccines based on Orexo's AmorphOX powder engineering technology and Abera's vaccine platform, starting with an influenza vaccine. Abera will fund the project using grant money it has received from the … [Read more...] about Orexo and Abera partner on development of intranasal dry powder vaccines
ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is partnered with Pediatrix Therapeutics in China; with Alfresa Pharma in Japan; and with CSL Seqirus in Australia … [Read more...] about ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the rights to market Afrezza in India in a deal signed in 2018. Afrezza has been approved in the US since 2014 and … [Read more...] about MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
Merxin and OECHSLERhealth partner on SMI development services
Merxin Ltd and contract device manufacturer OECHSLERhealth have announced the formation of a strategic partnership called The SMI PowerHouse for manufacturing of Merxin's MRX004 soft mist inhaler, a generic version of the Respimat device. According to the announcement, the two companies have worked together since 2018. Merxin and OECHSLERhealth say that the … [Read more...] about Merxin and OECHSLERhealth partner on SMI development services