Calls for papers
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The FDA has announced its approval of a Cipla albuterol sulfate MDI, a generic of 3M’s Proventil HFA for the treatment of asthma. The FDA announcement noted that the agency recently issued a revised draft… Read more . . .
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Liquidia Technologies said that the FDA accepted the company’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA goal date of November 24, 2020. The company announced in… Read more . . .
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Third Pole Therapeutics has announced a deal with Chiesi Farmaceutici giving Chiesi global rights to develop and commercialize Third Pole’s tankless inhaled nitric oxide (iNO) delivery system for the treatment of infants with hypoxic respiratory… Read more . . .
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A meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) that had been scheduled for April 21, 2020 has been postponed due to the COVID-19 pandemic. No new meeting date was announced. The committee was… Read more . . .
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Bryn Pharma announced the publication of a poster presenting data from a Phase 1 PK/PD study of its BRYN-NDS1C intranasal epinephrine, which is delivered via an Aptar Pharma Bidose nasal device. In October 2019, Bryn… Read more . . .
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Savara announced that it has acquired global development and commercialization rights to Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin from Grifols. According to Savara, the deal includes an upfront payment to Grifols and regulatory milestone payments if… Read more . . .
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The University of Wisconsin–Madison has announced that virologists from the university have partnered with vaccine companies FluGen and Bharat Biotech on development of an intranasal vaccine against unique vaccine against SARS-CoV-2 for the prevention of… Read more . . .
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Swiss biotech Neurimmune has partnered with German mRNA specialist Ethris to develop inhaled mRNA-encoded neutralizing anti-SARS-CoV-2 antibodies for the treatment of Covid-19, the companies said. The goal is to begin clinical manufacturing of the drug… Read more . . .
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Austrian biotech APEPTICO said that it has signed a grant agreement with the European Commission to accelerate the availability of the company’s solnatide (AP301), an inhaled peptide, available for treatment of patients with severe COVID-19. APEPTICO… Read more . . .
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A number of Cambridge, UK-based companies with extensive experience in inhaler design and development have responded to a request from the UK government to join an initiative to rapidly increase the country’s manufacture of ventilators in… Read more . . .
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