Calls for papers
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AZ Therapies has announced that the Phase 3 COGNITE study of ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of early stage Alzheimer’s disease has completed enrollment. The company, which announced the initiation of the study… Read more . . .
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Italfarmaco has announced that it will pay Neupharma “a total sum up to double digits in USD millions, excluding royalties” for an exclusive option to acquire global development and commercialization rights to inhaled teicoplanin for… Read more . . .
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A spokesperson for Novartis has confirmed to OINDPnews that Mylan exercised an option to acquire a San Carlos, CA, USA manufacturing facility for TOBI inhaled tobramycin products in May 2019 and is expected to acquire… Read more . . .
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Auris Medical has announced the initiation of the Phase 2 TRAVERS trial of its AM-125 intranasal betahistine for the treatment of acute vertigo resulting from removal of a vestibular schwannoma. Auris is also developing intranasal… Read more . . .
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According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods)… Read more . . .
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Italian pharmaceutical company Zambon announced that it has paid €140 million up front for Breath Therapeutics, which is developing L‑CsA‑i inhaled liposomal Cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS). The deal includes… Read more . . .
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The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in… Read more . . .
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Oyster Point Pharma has announced the initiation of the Phase 3 ONSET-2 study of its OC-01 nicotine acetylcholine receptor (nAChR) agonist nasal spray for the treatment of dry eye disease. In October 2018, the company… Read more . . .
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BlueWillow Biologics announced that it has been issued US patent No. 10,206,996, titled “Herpes simplex virus nanoemulsion vaccine,” covering an intranasal herpes simplex virus (HSV) vaccine based on its NanoVax adjuvant platform. The company is… Read more . . .
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The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016.… Read more . . .
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA