Bayer said that its Astepro Allergy azelastine nasal spray is now available over the counter in US retail stores for the treatment of respiratory allergy symptoms in people aged 6 and older. The FDA approved Astepro Allergy for nonprescription use in June 2021. Bayer Consumer Health US VP and General Manager of Upper Respiratory Catherine Vennat said, "At Bayer, … [Read more...] about Bayer launches Astepro Allergy nasal spray in the US
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Padagis launches generic of Narcan naloxone nasal spray
Padagis, formerly Perrigo's generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the US since the FDA's initial approval of Narcan in 2015. Teva’s version of Narcan was approved by the FDA in April 2019 and was … [Read more...] about Padagis launches generic of Narcan naloxone nasal spray
Glenmark launches Indamet indacaterol / mometasone DPI for the treatment of asthma in India
Glenmark Pharmaceuticals has announced the launch of an inhaled dry powder fixed dose combination of indacaterol and mometasone furoate for the treatment of asthma which is being marketed under the name "Indamet". All three of the strengths offered include 150 mcg of indacaterol, plus either 80, 160, or 320 mcg of mometasone. Glenmark Group VP and Head, India … [Read more...] about Glenmark launches Indamet indacaterol / mometasone DPI for the treatment of asthma in India
Esteve Pharmaceuticals launches Inbrija levodopa DPI in Germany
Acorda Therapeutics announced that Inbrija levodopa inhalation powder has been launched in Germany by Esteve Pharmaceuticals. The EMA approved Inbrija DPI for the treatment of OFF periods in Parkinson’s disease in 2019. Acorda said that Esteve will pay "a significant double-digit percent of the selling price" plus sales based milestone payments. In July 2021, … [Read more...] about Esteve Pharmaceuticals launches Inbrija levodopa DPI in Germany
Opiant invests €2 million for expanded production of Aptar nasal device for use with OPNT003
Opiant Pharmaceuticals announced that it has signed an agreement with Aptar Pharma for expanded production of Aptar’s Unidose device in order to support potential commercial demand for Opiant's OPNT003 intranasal nalmefene. The agreement includes €2 million from Opiant for installation of the necessary production equipment. Opiant recently initiated a rolling NDA … [Read more...] about Opiant invests €2 million for expanded production of Aptar nasal device for use with OPNT003
Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF
According to Moderna Therapeutics, the company used its annual "Science and Technology Day" to highlight its work on lipid nanoparticle (LNP) mRNA formulations, and CEO Stéphane Bancel made special note of the company's advances in pulmonary delivery, including a partnership with Vertex on development of an inhaled mRNA formulation that could give CF patients the … [Read more...] about Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF
Spirovant opens new lab and headquarters
Sumitovant subsidiary Spirovant Sciences, which is developing inhaled gene therapies for the treatment of cystic fibrosis, has opened a new research laboratory and corporate headquarters in Philadelphia, PA, USA, the company said. Spirovant's SP-101 inhaled adeno-associated virus (AAV) gene therapy for CF has been granted orphan disease and rare pediatric disease … [Read more...] about Spirovant opens new lab and headquarters
Pieris warns of potential delays in clinical trial of PRS-060/AZD1402 DPI
In a business update, Pieris Pharmaceuticals warned that an ongoing clinical trial of its dry powder PRS-060/AZD1402 IL-4 receptor alpha inhibitor may take longer than expected, saying "Given the geopolitical situation, along with broader challenges amidst an ongoing pandemic, there is a heightened risk that more time will be required to deliver the topline study … [Read more...] about Pieris warns of potential delays in clinical trial of PRS-060/AZD1402 DPI
Evoke gets new drug product exclusivity for Gimoti nasal spray
Evoke Pharma announced that the FDA has granted new drug product exclusivity for Gimoti metoclopramide nasal spray, giving the company exclusive marketing rights for 3 following the initial approval date. The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020. The company also noted that it has two patents covering Gimoti listed in the … [Read more...] about Evoke gets new drug product exclusivity for Gimoti nasal spray
Neurelis gets additional patent covering Valtoco nasal spray
According to Neurelis, the US Patent and Trademark Office (USPTO) has issued a new patent covering Valtoco diazepam nasal spray. The abstract for US Patent No. 11,241,414, titled "Administration of benzodiazepine compositions," says that it "relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for … [Read more...] about Neurelis gets additional patent covering Valtoco nasal spray