The FDA has issued a clinical hold on Altimmune's IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020. According to the company, the FDA requested additional CMC data as well as changes to the protocols, and Altimmune has already responded to the clinical hold letter, which was … [Read more...] about FDA places clinical hold on Altimmune’s IND for AdCOVID
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Menarini acquires rights to market Ryaltris nasal spray in 33 European countries
Menarini will pay Glenmark an undisclosed amount up front plus milestone payments for exclusive rights to market Ryaltris olopatadine/mometasone furoate nasal spray in 33 European countries, Ryaltris developer Glenmark has announced. Glenmark will be continue to be responsible for European development and regulatory approval of the nasal spray for the treatment of … [Read more...] about Menarini acquires rights to market Ryaltris nasal spray in 33 European countries
Polyphor to initiate Phase 1 trial of inhaled murepavadin
According to Polyphor, the UK's MHRA has authorized a Phase 1 study of the company's murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients. Initiation of the study, which is partially funded by the European Innovative Medicines Initiative, is expected within weeks. The … [Read more...] about Polyphor to initiate Phase 1 trial of inhaled murepavadin
Monash selects Iconovo’s ICOone DPI for its inhaled oxytocin for the prevention of postpartum hemorrhage
Swedish DPI developer Iconovo announced that Monash University has acquired exclusive global rights for the use of Iconovo's ICOone single dose DPI for delivery of Monash's inhaled oxytocin for the prevention of postpartum hemorrhage. The agreement includes €900,000 in milestone payments, as well as royalties paid for 20 years after launch of the product. Successful … [Read more...] about Monash selects Iconovo’s ICOone DPI for its inhaled oxytocin for the prevention of postpartum hemorrhage
Tonix to develop intranasal oxytocin for the treatment of insulin resistance and obesity
Several months after acquiring the rights to TNX-1900 oxytocin nasal spray for the treatment of migraine headaches from Trigemina, Tonix Pharmaceuticals announced that it has acquired an exclusive license to technology from the University of Geneva for the use of oxytocin to treat insulin resistance and related conditions such as obesity. The company has not yet … [Read more...] about Tonix to develop intranasal oxytocin for the treatment of insulin resistance and obesity
Novan selects Catalent for development of intranasal berdazimer sodium
Catalent will supply development services for an intranasal formulation of Novan's berdazimer sodium for COVID-19, the companies said. Berdazimer sodium is a nitric oxide-releasing polymer based on Novan's Nitricil platform, and the company is developing topical gel formulations for the treatment of viral dermatological infections, including molluscum and genital … [Read more...] about Novan selects Catalent for development of intranasal berdazimer sodium
Oyster Point submits NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease
Oyster Point Pharma has announced its submission of a 505(b)(2) NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease. In May 2020, Oyster Point announced positive results from the the Phase 3 ONSET-2 trial. The company says that data from the Phase 2b ONSET-1, and Phase 2 MYSTIC trials are also used to support the NDA submission. Oyster … [Read more...] about Oyster Point submits NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease
PrEP Biopharm to initiate trial of PrEP-001 intranasal Poly I:C against respiratory viruses
Johnson & Johnson spinout PrEP Biopharm said that it is ready to initiate a real-world trial of its PrEP-001 intranasal "viral RNA surrogate" against common respiratory viruses after the successful completion of a toxicology study in dogs. The trial is designed to evaluate the efficacy PrEP-001, an intranasal dry powder formulation of polyinosinic:polycytidylic … [Read more...] about PrEP Biopharm to initiate trial of PrEP-001 intranasal Poly I:C against respiratory viruses
Hikma gets FDA approval for, and launches, generic version of Advair Diskus
Hikma Pharmaceuticals announced that the FDA has approved 100 mcg/50 mcg and 250 mcg/50 mcg doses of the company's fluticasone propionate / salmeterol DPI (VR315), a generic version of Advair Diskus and that the company has launched the inhaler in the US. The FDA had issued a minor CRL in response to the ANDA in September 2020. A previous CRL had been issued in May … [Read more...] about Hikma gets FDA approval for, and launches, generic version of Advair Diskus
DDL 2020 continues to offer benefits for the OINDP community
By the time DDL 2020 began its live "Christmas lectures" on December 9, more than 1,450 delegates had registered for the meeting. Although the live presentations concluded on December 11, there are still benefits to registering if you have not already (especially because registration is free) and to continuing to log in if you are already registered. Not only are all … [Read more...] about DDL 2020 continues to offer benefits for the OINDP community