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News

CDE activates DMF for Lindal’s KHFA metering valve

Lindal Group announced that the Chinese National Medical Product Administration's (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal's 20 mm male MDI metering valve as active following review. The company said that "the inclusion of the KHFA valve marks significant progress in Lindal headway into the Chinese aerosol dispensing … [Read more...] about CDE activates DMF for Lindal’s KHFA metering valve

Noble launches “Human Factors Plus” service

Aptar Pharma subsidiary Noble has launched a suite of services for makers of combination products such as OINDPs under the "Human Factors Plus" (HF+) brand. Noble, which was acquired by Aptar Pharma in 2019, makes respiratory and intranasal training devices and patient onboarding platforms. The HF+ umbrella includes a number of services related to regulatory strategy, … [Read more...] about Noble launches “Human Factors Plus” service

Chiesi’s Trimbow triple combination MDI approved for the treatment of asthma in the EU

The European Commission has approved Chiesi's Trimbow extrafine beclometasone / formoterol / glycopyrronium MDI for the treatment of asthma in patients who do not have adequate control with ICS/LABA and who have had at least one exacerbation over the previous year. In October 2019, Chiesi announced positive results from the Phase 3 TRIGGER and TRIMARAN studies of the … [Read more...] about Chiesi’s Trimbow triple combination MDI approved for the treatment of asthma in the EU

Phase 2 trial of Verona’s MDI formulation of ensifentrine meets primary and secondary endpoints

Verona Pharma reported that a Phase 2 study of 3 dose levels of its MDI formulation of ensifentrine in patients with moderate to severe COPD met all of its primary and secondary endpoints, demonstrating significant improvements in lung function compared to placebo. Improvements in peak FEV1 ranged from 205 mL for a 300 µg dose to 326 mL for a 3000 µg dose. Verona had … [Read more...] about Phase 2 trial of Verona’s MDI formulation of ensifentrine meets primary and secondary endpoints

Revelation Biosciences raises $4.4 million for development of REVTx‑99 intranasal PHAD

Revelation Biosciences said that it has closed a private placement financing with gross proceeds of $4.4 million that it plans to use for development of two pipeline products, including its REVTx-99 intranasal phosphorylated hexaacylated disaccharide (PHAD). REVTx-99 is in development for the treatment of viral respiratory infections, including COVID-19.  In … [Read more...] about Revelation Biosciences raises $4.4 million for development of REVTx‑99 intranasal PHAD

Noveome partners with Walter Reed Army Institute of Research on preclinical study of intranasal ST266 secretome

Noveome Biotherapeutics has signed a research and development agreement with Walter Reed Army Institute of Research (WRAIR) regarding preclinical studies of an intranasal formulation of Noveome's ST266 secretome, the company said. Under the agreement, WRAIR Branch Chief Deborah Shear will evaluate intranasal ST266 in animal models of traumatic brain injury (TBI), with … [Read more...] about Noveome partners with Walter Reed Army Institute of Research on preclinical study of intranasal ST266 secretome

Ovoca Bio initiates Phase 2 study of BP-101 nasal spray for the restoration of sexual desire in premenopausal women

Ovoca Bio announced that it has initiated a Phase 2 study of its BP-101 intranasal synthetic peptide for the treatment of hypoactive sexual desire disorder (HSDD). The dose ranging study, which will take place in Australia and New Zealand, is expected to enroll 476 premenopausal women who are experiencing distress due to low libido and will evaluate the effects of … [Read more...] about Ovoca Bio initiates Phase 2 study of BP-101 nasal spray for the restoration of sexual desire in premenopausal women

US Department of Defense provides up to $6 million for Phase 2 trials of PUL-042 inhalation solution for the treatment of COVID-19

According to Pulmotect, the US Department of Defense has provided a grant worth up to $6 million for the completion of two Phase-2 clinical trials of the company's PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19. In May 2020, Pulmotect announced that it had gotten FDA permission for the two trials. The studies, which both … [Read more...] about US Department of Defense provides up to $6 million for Phase 2 trials of PUL-042 inhalation solution for the treatment of COVID-19

AIM ImmunoTech announces planned Phase 1 study of intranasal Ampligen

AIM ImmunoTech announced that the Centre for Human Drug Research (CHDR) will conduct a Phase 1 study of an intranasal formulation of the company's Ampligen rintatolimod, which the company wants to develop for the treatment of COVID-19. IV Ampligen is currently approved in Argentina for the treatment of chronic fatigue syndrome, and AIM recently began treating some … [Read more...] about AIM ImmunoTech announces planned Phase 1 study of intranasal Ampligen

Symbicort Turbuhaler approved in China for the treatment of mild asthma

According to AstraZeneca, China's National Medical Products Administration (NMPA) has approved Symbicort Turbuhaler budesonide / formoterol as a reliever inhaler for the treatment of symptoms of mild asthma in patients age 12 and older. Symbicort Turbuhaler was already approved in China for the treatment of moderate-to-severe asthma as a maintenance therapy and as a … [Read more...] about Symbicort Turbuhaler approved in China for the treatment of mild asthma

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