Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US "due to superpotency or amounts of desmopressin higher than specified." The recall includes 6 lots of DDAVP, 15 … [Read more...] about Desmopressin nasal sprays recalled in US
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Bryn Pharma raises $11 million for continued development of its epinephrine nasal spray
Bryn Pharma said that it has raised $11 million in an extension of the financing that raised over $17 million in October 2019 to fund activities related to its BRYN-NDS1C epinephrine nasal spray candidate, which is delivered via Aptar Pharma's Bidose nasal device. According to Bryn, proceeds from this financing will be used for continued development of BRYN-NDS1C, as … [Read more...] about Bryn Pharma raises $11 million for continued development of its epinephrine nasal spray
United Therapeutics gets new patent for Tyvaso, adds to patent infringement claims against Liquidia
United Therapeutics announced that it has been issued a new US patent covering Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and that it has subsequently amended its recently filed suit against Liquidia Technologies to include infringement of the new patent. The patent infringement suit initially referenced two US … [Read more...] about United Therapeutics gets new patent for Tyvaso, adds to patent infringement claims against Liquidia
Janssen announces launch of Spravato esketamine nasal spray in Canada
Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato is meant to be used under direct supervision of a healthcare professional, and in combination with an oral antidepressant, when … [Read more...] about Janssen announces launch of Spravato esketamine nasal spray in Canada
Verona Pharma raises approximately $200 million for Phase 3 development of nebulized ensifentrine
Verona Pharma announced that it has raised approximately $200 million in a private placement, with net proceeds of ~$183 million to be used for Phase 3 development of nebulized ensifentrine for the treatment of COPD. The company said that the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program is expected to begin later this year. In … [Read more...] about Verona Pharma raises approximately $200 million for Phase 3 development of nebulized ensifentrine
Ferring issues recall of desmopressin nasal sprays
According to the UK's Medicines & Healthcare products Regulatory Agency (MHRA), Ferring Pharmaceuticals has recalled multiple batches of Desmospray 0.1 mg/ml desmopressin, Aspire branded desmopressin 0.1 mg/ml, and Octim desmopressin 1.5 mg/ml nasal sprays "due to a lower volume of solution being observed in the bottles, and out of specification results for the … [Read more...] about Ferring issues recall of desmopressin nasal sprays
ARS Pharmaceuticals gets second US patent for its epinephrine nasal spray
The United States Patent and Trademark Office has issued US Patent No. 10682414, titled, "Intranasal epinephrine formulations and methods for the treatment of disease," to ARS Pharmaceuticals, the company said. The patent covers the use of low dose (0.1 to 2.4 mg) intranasal epinephrine for for the treatment of anaphylaxis. The patent covers any low-dose … [Read more...] about ARS Pharmaceuticals gets second US patent for its epinephrine nasal spray
Teva launches ProAir Digihaler in the US
Teva has announced the US launch of the ProAir Digihaler albuterol DPI for the treatment of bronchospasm. The list price for the inhaler will be $146.67. ProAir Digihaler, which includes built-in sensors connected to a mobile app via Bluetooth, was approved by the FDA in December 2018. The company said that it also has plans to launch the AirDuo Digihaler … [Read more...] about Teva launches ProAir Digihaler in the US
Nephron Pharmaceuticals announces expansion plans
Inhalation solutions and suspensions manufacturer Nephron Pharmaceuticals has announced plans for a $215 million expansion at its South Carolina, USA facilities, including office, warehouse and vaccine production space. In addition to manufacturing its own products, Nephron also offers contract manufacturing services for sterile pharmaceutical products. The expansion … [Read more...] about Nephron Pharmaceuticals announces expansion plans
Optinose partners with Kaleo for promotion of Xhance intranasal fluticasone
Optinose announced that it has signed an agreement with Kaleo for co-promotion of Optinose's Xhance fluticasone propionate nasal spray for the treatment of nasal polyps. Xhance was approved by the FDA for that indication in September 2017. The agreement calls for Kaleo to promote the nasal spray to a group of almost 6,000 healthcare providers in the US. Optinose … [Read more...] about Optinose partners with Kaleo for promotion of Xhance intranasal fluticasone