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Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints

Aridis Pharmaceuticals has announced that a Phase 2a study of the company's AR-501 nebulized gallium in cystic fibrosis patients with P. aeruginosa lung infections met its primary and secondary endpoints, with all 3 dose levels tested being well tolerated. According to Aridis, uptake of AR-501 in the respiratory track was up to 10 times higher than previously reported … [Read more...] about Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints

ReCode initiates Phase 1 trial of RCT1100 inhaled mRNA therapeutic

ReCode Therapeutics said that it has initiated a Phase 1 clinical trial of its RCT1100 nebulized mRNA-based therapeutic, which the company is developing for the treatment of primary ciliary dyskinesia (PCD) caused by certain genetic mutations. ReCode had announced positive preclinical results for RCT1100 for the treatment of PCD in August 2021. The Phase 1 single … [Read more...] about ReCode initiates Phase 1 trial of RCT1100 inhaled mRNA therapeutic

Lonza Small Molecules adds powder characterization capabilities at Florida facility

The Lonza Small Molecules facility in Tampa, FL, USA has upgraded its powder analysis capabilities, the company said. In May 2022, Lonza announced that it was expanding its dry powder testing facilities in Tampa in order to increase its DPI development capacity. According to Lonza, the Tampa site recently added a Freeman Technologies FT4 universal powder flow … [Read more...] about Lonza Small Molecules adds powder characterization capabilities at Florida facility

Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine

Iliad Biotechnologies announced that it has published data from a Phase 2b challenge study of its BPZE1 live-attenuated intranasal pertussis vaccine and said that the vaccine induced nasal mucosal and serum immune responses, with 90% of participants who received a single dose of BPZE1 protected from colonization following a challenge with attenuated B. pertussis at 3 … [Read more...] about Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine

FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine

The FDA has approved Pfizer's Zavzpret zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine. Pfizer said that it expects to launch Zavzpret in July 2023. The FDA accepted the NDA for the zavegepant (formerly "vazegepant") nasal spray submitted by Biohaven Pharmaceuticals in May 2022. Biohaven … [Read more...] about FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine

FDA approves Amphastar’s naloxone nasal spray for the treatment of opioid overdose

The FDA has approved Amphastar Pharmaceuticals' NDA for 4 mg intranasal naloxone for the treatment of opioid overdose. According to the company, the nasal spray is delivered via a proprietary delivery device. A previous Amphastar NDA for a 2mg naloxone nasal spray received a CRL from the NDA in 2017, with the FDA asking for additional human factors and device … [Read more...] about FDA approves Amphastar’s naloxone nasal spray for the treatment of opioid overdose

Esteve Pharmaceuticals launches Inbrija levodopa DPI in Spain

According to Acorda Therapeutics, Esteve Pharmaceuticals has launched Acorda's Inbrija inhaled dry powder levodopa in Spain. Acorda announced the Spanish distribution deal with Esteve in July 2021. Inbrija DPI has been approved in Europe for the treatment of OFF periods in Parkinson’s disease since 2019.  Acorda President and CEO Ron Cohen said, "Today’s … [Read more...] about Esteve Pharmaceuticals launches Inbrija levodopa DPI in Spain