August 2012
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Intravacc announced that it has initiated a Phase 1 trial of Avacc 10 intranasal SARS-CoV-2 subunit vaccine, which the company is developing as a booster. Avacc 10 is based on the same outer membrane vesicles… Read more . . .
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After receiving a “Study May Proceed” letter from the FDA, Vistagen has announced plans for a Phase 1 trial of a re-formulated version of PH10 pherin nasal spray. The new Phase 1 study is expected… Read more . . .
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Nuance Pharma has announced a deal with DKSH Business Unit Healthcare for commercialization of Bentrio, an API-free, bentonite-based OTC nasal spray for protection against allergens and viruses, in Hong Kong and Macau. Bentrio is currently marketed… Read more . . .
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Adherium announced that the FDA has granted 510(k) clearance for use of Adherium’s next-generation Hailie inhaler sensor with GSK’s Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August… Read more . . .
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According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA’s decision on acceptance of the application is expected in… Read more . . .
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Belgium-based Hyloris Pharmaceuticals announced that it has added an intranasal TRPV1 agonist (HY-083) for the treatment of idiopathic rhinitis to its pipeline. TRPV1 (transient receptor potential cation channel subfamily V member 1) is overexpressed in… Read more . . .
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Aerovate Therapeutics has published data from a Phase 1 study of its AV-101 dry powder imatinib showing that the inhaled formulation resulted in significantly lower systemic exposure compared to oral imatinib. The company announced the… Read more . . .
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InvisiShield Technologies, which is developing a human antibody nasal spray designed to prevent SARS-CoV-2 infection, has announced the appointment of Gladstone Institute of Virology and Immunology founding director Warner C. Greene as President and Chief… Read more . . .
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CDMO Kindeva Drug Delivery, which specializes in inhalation, intradermal, and transdermal drug delivery, has announced that it will merge with fellow Altaris Capital Partners company Meridian Medical Technologies, which specializes in autoinjectors. Altaris acquired Kindeva… Read more . . .
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The FDA has issued a notice in the Federal Register titled, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.” The agency says that its preliminary opinion is that autoinjectors with doses up… Read more . . .
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