Calls for papers
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Former Arranta Bio CEO David Stevens has joined CDMO Kindeva Drug Delivery as Chief Commercial Officer, the company said. Prior to Arranta, Stevens held a variety of roles at Albany Molecular Research, Aptuit, and Charles… Read more . . .
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Tiziana Life Sciences announced that it will advance its intranasal foralumab anti-CD3 monoclonal antibody into clinical development for the treatment of hemorrhagic stroke after a pre-clinical study in a model of intracerebral hemorrhage demonstrated improvement… Read more . . .
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Liquidia Corporation said that a new agreement will supersede its 2012 license agreement with GSK that gave GSK exclusive rights to develop certain inhaled formulations based on Liquidia’s PRINT particle engineering technology. In 2015, GSK exercised… Read more . . .
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Orexo announced that the FDA will require the company to resubmit its NDA for OX124 intranasal dry powder naloxone due to “unexpected technical issues with the equipment used for the secondary packaging process in the… Read more . . .
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DPI developer PureIMS announced that it has closed an investment round that included Boost-UP Foundation, CardusoCapital, IMDS Medical Devices, and LinesBridge Pharma Group, with funds intended mostly to support development of a levodopa DPI based… Read more . . .
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The FDA has granted Fast Track designation to Renovion’s ARINA-1 nebulized mucolytic for the prevention of bronchiolitis obliterans syndrome in patients who have had a bilateral lung transplant, which will allow the company to take… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has scheduled a meeting on May 11, 2023 to review the ARS Pharmaceuticals’ NDA for Neffy intranasal epinephrine for the treatment of anaphylaxis and other Type 1 allergic reactions. The… Read more . . .
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The FDA has approved Emergent Biosolutions’ sNDA for OTC sales of Narcan naloxone nasal spray, 4 mg, for reversal of opioid overdose. Narcan was first approved for prescription use in the US in 2015. The… Read more . . .
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Tiziana Life Sciences says that after receiving feedback from the FDA following a Type C meeting, the company plans to move forward with a Phase 2 trial of intranasal foralumab, a human anti-CD3 mAb, in… Read more . . .
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MannKind Corporation has named former Acorda Therapeutics COO Lauren Sabella as Executive VP, Chief Operating Officer. Sabella’s experience includes 12 years at Acorda, first as Chief Commercial Officer and then as COO; she previously served in a… Read more . . .
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