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Medlab Clinical gets grant from NSW government for intranasal RNA vaccine against COVID-19

Australian biotech Medlab Clinical said that it has received a grant from the New South Wales government for development of a proof-of-concept intranasal vaccine based on its NanoCelle "sub-micron delivery platform" technology. The company added that it will develop the vaccine in partnership with OINDP specialist Daniela Traini of the Woolcock Institute of Medical … [Read more...] about Medlab Clinical gets grant from NSW government for intranasal RNA vaccine against COVID-19

Poolbeg Pharma licenses intranasal antiviral from the University of Warwick

Open Orphan spin-out Poolbeg Pharma said that it has acquired an exclusive license for an intranasal RNA-based immunotherapy for the prevention and treatment of viral respiratory infections from the University of Warwick. According to the company, in vivo studies have demonstrated that the antiviral, which Poolbeg is calling POLB 002, has the potential to be effective … [Read more...] about Poolbeg Pharma licenses intranasal antiviral from the University of Warwick

Levo Therapeutics gets CRL for LV-101 intranasal carbetocin for PWS

Levo Therapeutics announced that the FDA has issued a complete response letter to the company's NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger and anxiety associated with Prader-Willi syndrome (PWS). The FDA accepted the application for priority review in July 2021. According to Levo, the FDA has requested an additional clinical study to … [Read more...] about Levo Therapeutics gets CRL for LV-101 intranasal carbetocin for PWS

IPAC-RS announces board changes

The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) has announced that Kindeva Drug Delivery Global Respiratory Product Development Manager Mike Needham will serve as Vice Chair of the IPAC-RS board until June 1, 2022 and will then take over as Chair, succeeding Carla Vozone of Catalent Pharma Solutions who will become Chair … [Read more...] about IPAC-RS announces board changes

FDA approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis

Glenmark Pharmaceuticals announced that it has received FDA approval of its NDA for Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older. The FDA accepted the NDA for Ryaltris in August 2018 and issued a CRL to the application in June 2019. Since that time, Ryaltris has been … [Read more...] about FDA approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis

Theravance Biopharma initiates Phase 4 trial of Yupelri inhalation solution

Theravance Biopharma has announced the initiation of a Phase 4 study of Yupelri revefenacin inhalation solution, which was approved by the FDA in 2018 for the treatment of COPD. The PIFR-2 study, which is expected to enroll 366 patients with severe to very severe COPD, will compare Yupelri to Spiriva HandiHaler tiotropium DPI over 12 weeks. Topline results are … [Read more...] about Theravance Biopharma initiates Phase 4 trial of Yupelri inhalation solution

RxPack names Alberto Colombo as Head of R&D and Customer Technical Support

RxPack, a new device company formed from a joint venture between Lindal and Coster in 2021, has announced the appointment of inhaler development specialist Alberto Colombo as Head of R&D and Customer Technical Support. Colombo was most recently a device development specialist at Chiesi, where he managed MDI projects,and previously spent approximately 10 years … [Read more...] about RxPack names Alberto Colombo as Head of R&D and Customer Technical Support

I-SPY COVID trial finds no clinical benefit for use of Pulmozyme in severe COVID-19

According to Quantum Leap Healthcare Collaborative (QLHC), a sponsor of the I-SPY COVID trial, interim analysis of data from a study of Genentech's Pulmozyme dornase alfa inhalation solution for the treatment of severe COVID-19 found that Pulmozyme therapy "is unlikely to achieve statistically significant improvement in efficacy," and the Pulmozyme arm of the trial … [Read more...] about I-SPY COVID trial finds no clinical benefit for use of Pulmozyme in severe COVID-19