News
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The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019. According to… Read more . . .
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Merxin Ltd and Perlen Packaging have announced that they will co-develop inhaled cannabis products based on Perlen’s BLISTair single use dry powder inhaler, with Merxin developing the formulations and marketing the cannabis DPIs. The BLISTair… Read more . . .
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Aradigm Corporation, which recently announced that it has filed for bankruptcy, said that it held a Type B meeting with the FDA on January 25, 2019 at which the agency expressed continued concerns about data… Read more . . .
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Opiant Pharmaceuticals said that it has discontinued development of OPNT001 naloxone nasal spray for the treatment of bulimia nervosa (BN) after a Phase 2 study failed to meet its primary endpoint. The company had announced… Read more . . .
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RDD Europe 2019 will take place May 7-10 at the Estoril Congress Center outside of Lisbon. Organizers expect approximately 500 inhaled and nasal drug specialists from industry, academia, and regulatory agencies to attend this year’s… Read more . . .
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One of the distinguishing features of RDD Europe is the workshop session, when a dozen companies offer 60-minute presentations on their latest technology, products, or services to small groups of 10-40 people at a time.… Read more . . .
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Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101… Read more . . .
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Inhaled cannabinoid developer Senzer said that it believes the company is the first to receive ISO 13485:2016 certification for design and development of a pharmaceutical-grade cannabinoid delivery device. Senzer’s Systemic inhaled Delivery Device (SiDD) platform… Read more . . .
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ARS Pharmaceuticals said that the FDA has granted Fast Track designation to its ARS-1 intranasal epinephrine, which is in development for the treatment of anaphylaxis. In December 2018, the company announced that it had raised… Read more . . .
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Intranasal drug developer Impel NeuroPharma has announced the appointment of Jennifer L. Berman VP of Marketing. Berman was most recently Worldwide Brand Director at Novartis Pharmaceuticals. In December 2018, Impel announced that it had raised $67.5 million… Read more . . .
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