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Proveris Scientific

Regulatory

FDA lifts clinical hold on Penthrox methoxyflurane inhaler

According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP's Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it … [Read more...] about FDA lifts clinical hold on Penthrox methoxyflurane inhaler

FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail

Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three … [Read more...] about FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail

Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB

According to Armata Pharmaceuticals, the FDA has cleared the company's IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2 trial of AP-PA02 in NCFB patients this year. AP-PA02 is already in clinical development for the treatment of lung infections in cystic … [Read more...] about Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB

FDA approves Lupin’s arformoterol tartrate inhalation solution

The FDA has now fully approved Lupin's ANDA for its generic version of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006. The agency tentatively approved Lupin's ANDA for the arformoterol tartrate inhalation solution in April 2020, and in June 2021, Lupin announced the launch of an … [Read more...] about FDA approves Lupin’s arformoterol tartrate inhalation solution

Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19

Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had partnered with Inhalon Biopharma on development of an inhaled formulation of regdanvimab for the treatment of COVID-19. The proposed Phase 3 trial, … [Read more...] about Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19

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

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

SpliSense inhaled antisense oligonucleotide for CF gets orphan drug designation from both FDA and EMA

Israeli biopharm SpliSense has announced that both the FDA and the EMA have granted orphan drug designation to the company's SPL84-23-1 inhaled antisense oligonucleotide (ASO) for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. According to the company, preclinical studies have demonstrated that treatment with SPL84-23-1 can "enable … [Read more...] about SpliSense inhaled antisense oligonucleotide for CF gets orphan drug designation from both FDA and EMA

Iliad Biotechnologies gets Fast Track designation for its intranasal booster vaccine against pertussis

According to Iliad Biotechnologies, the FDA has granted Fast Track designation to Iliad's BPZE1 live attenuated intranasal vaccine against pertussis (whooping cough), which is in Phase 2 development as a booster vaccine to prevent both colonization by B. pertussis and disease caused by the bacterium. Iliad licensed the intranasal pertussis vaccine, which was … [Read more...] about Iliad Biotechnologies gets Fast Track designation for its intranasal booster vaccine against pertussis