The FDA and AstraZeneca are both touting the agency's approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to review AstraZeneca's sBLA for the self-administration change in October 2023. FluMist will still be available for healthcare provider … [Read more...] about FDA approves FluMist intranasal flu vaccine for self-administration
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FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to "significant microbial contamination in SnoreStop Nasal Spray lot number 2460" detected during an inspection in April 2024 and is warning customers not to use the product. The FDA notes that the homeopathic product is unapproved and that Green previously recalled a … [Read more...] about FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease
Tiziana Life Sciences announced that a study of the company's intranasal anti-CD3 mAb will be funded by a $4 million grant from the National Institutes of Health. In June 2024, the company said that the FDA had approved the use of intranasal foralumab in a patient with moderate Alzheimer’s disease under an expanded access IND. Tiziana said that it anticipates … [Read more...] about Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease
Pulmotect raises $5.9 million in Series C funding to support Phase 2 trial of PUL-042 inhalation solution in cancer patients
Pulmotect announced that it has raised $5.9 million in a Series C funding to support a Phase 2 trial of the company's PUL-042 immunostimulant inhalation solution. According to Pulmotect, the new funds will be used along with an $8.9 million Product Development Research grant awarded last year by the Cancer Prevention and Research Institute of Texas (CPRIT) for the … [Read more...] about Pulmotect raises $5.9 million in Series C funding to support Phase 2 trial of PUL-042 inhalation solution in cancer patients
MannKind gets go-ahead for Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension in for NTM Japan
MannKind Corporation announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the initiation of the Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The company noted that the trial has already been cleared in the US, South Korea, and Australia; and … [Read more...] about MannKind gets go-ahead for Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension in for NTM Japan
Synairgen names Mark Parry-Billings as new Chairman of the Board
UK-based Synairgen, which is developing SNG001 inhaled interferon-beta-1a, announced that former Chiesi Global Head of Drug Development Mark Parry-Billings will succeed Simon Shaw as Chairman of the Board. Shaw will retire in October 2024. Prior to joining Chiesi in 2011, Parry-Billings was CEO of Topigen Pharmaceuticals, which was sold to Pharmaxis in 2010. His … [Read more...] about Synairgen names Mark Parry-Billings as new Chairman of the Board
Ritedose to manufacture Verona’s Ohtuvayre inhaled ensifentrine
CDMO Ritedose Corporation announced that it will manufacture Verona Pharma's Ohtuvayre nebulized ensifentrine, which was approved by the FDA in June 2024 for the treatment of COPD. Also in June 2024, Ritedose announced that it was adding blow-fill-seal (BFS) capacity for an additional 180 million unit doses at its manufacturing facility in Columbia, SC, … [Read more...] about Ritedose to manufacture Verona’s Ohtuvayre inhaled ensifentrine
Serán Bio gets $200 million investment to support new commercial manufacturing facility
CDMO Serán Bioscience announced "a strategic growth transaction" led by Bain Capital Life Sciences that is worth more than $200 million, with the funds intended to support completion of a new commercial-scale manufacturing facility in Bend, Oregon, where the company is headquartered. According to Serán Bio, the commercial-scale facility, which is expected to be … [Read more...] about Serán Bio gets $200 million investment to support new commercial manufacturing facility
Vectura to be acquired by Phillips Medisize parent Molex
Inhalation CDMO Vectura has been sold to Molex for £150 million up front and up to an additional £148 million in potential payments, the companies have announced. Following the acquisition, Vectura will be operated by Phillips Medisize, which was acquired by Molex in 2016. The sale is expected to close by the end of this year. According to the Vectura Fertin press … [Read more...] about Vectura to be acquired by Phillips Medisize parent Molex
Nuance to market Altamira’s Bentrio bentonite-based nasal spray in additional Asian countries
Altamira Therapeutics has announced an extension of its 2022 license and distribution agreement that gave Nuance Pharma the rights to market Altamira's Bentrio nasal spray in China, Hong Kong, Macau and South Korea. According to Altamira, Nuance has recently submitted a marketing application for Bentrio in China. The revised deal adds Singapore, Malaysia, Thailand, … [Read more...] about Nuance to market Altamira’s Bentrio bentonite-based nasal spray in additional Asian countries