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FDA places clinical hold on Altimmune’s IND for AdCOVID

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

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

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

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

Trixeo Aerosphere approved by EU for the treatment of COPD

The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the company said. The EMA's CHMP had adopted a positive opinion regarding the MAA for Trixeo Aerosphere in October … [Read more...] about Trixeo Aerosphere approved by EU for the treatment of COPD

Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine

Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix's CodaVax-RSV vaccine, which is also in Phase 1 development, COVI-VAC is based on Codagenix's SAVE codon … [Read more...] about Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine

CHMP adopts positive opinion regarding expanded indication for Spravato

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen's Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato "as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement … [Read more...] about CHMP adopts positive opinion regarding expanded indication for Spravato

United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF

According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation's benefits applying to both Tyvaso inhalation solution and Treprostinil Technosphere dry powder treprostinil. United Therapeutics also said that the FDA has cleared the company's IND … [Read more...] about United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF

AireHealth gets 510(k) clearance for connected nebulizer

According to Florida-based startup AireHealth, the company has received 510(k) clearance from the FDA for its VitalMed connected portable vibrating mesh nebulizer. Earlier this year, AireHealth acquired BreathResearch and its VitalBreath virtual respiratory health monitoring platform. In 2021, the company said, the VitalMed nebulizer will connect to a new app called … [Read more...] about AireHealth gets 510(k) clearance for connected nebulizer