Calls for papers
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Aptar said that the company has won a contract worth up to $6 million from the FDA for a study “designed to provide the FDA with information related to the formulation, manufacture, device design and… Read more . . .
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Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal… Read more . . .
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Scottish device company 1nhaler has raised £2 million for development of a credit-card sized dry powder inhaler in a funding round led by Archangels, the investment firm announced. The 1nhaler device is made out of… Read more . . .
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Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis… Read more . . .
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Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company’s RespiRx vibrating mesh nebulizer platform. In September 2022, the company… Read more . . .
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CDMO Hovione has announced a partnership with Industrial Design Consultancy (IDC) for development of two new devices for intranasal delivery of dry powder formulations. According to the announcement, the capsule-based single-use and multidose devices will… Read more . . .
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An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla’s metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited… Read more . . .
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According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase… Read more . . .
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Orexo said that the FDA has accepted the company’s NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The… Read more . . .
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According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company’s SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and… Read more . . .
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK