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Proveris Scientific

Regulatory

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

Ritedose launches budesonide inhalation suspension in US, gets FDA approval for albuterol inhalation solution

US-based Ritedose Pharmaceuticals, a subsidiary of CDMO Ritedose Corporation, has announced the launch of generic unit dose budesonide inhalation suspension (0.5 mg/2 ml) packaged for use in hospitals. Also, at the end of December, the FDA approved the company's ANDA for two strengths of albuterol inhalation solution, generic equivalents of Mylan's Accuneb. … [Read more...] about Ritedose launches budesonide inhalation suspension in US, gets FDA approval for albuterol inhalation solution

Only one patent remains in contention in the United Therapeutics effort to delay final FDA approval of Liquidia’s Yutrepia treprostinil DPI

According to Liquidia Corporation, United Therapeutics has agreed to a court judgment finding that Liquidia did not infringe United Therapeutic's US Patent No. 9,604,901. In October 2021, an inter partes review by the US Patent Trial and Appeal Board (PTAB) determined that 7 of the 9 claims in that patent were invalid. United Therapeutics initially filed suit … [Read more...] about Only one patent remains in contention in the United Therapeutics effort to delay final FDA approval of Liquidia’s Yutrepia treprostinil DPI

Kenox says it has completed pre-IND meeting with FDA regarding its inhaled sensitizer for lung cancer radiation therapy

According to Kenox Pharmaceuticals, the company "received a positive response supporting the planned CMC, non-clinical and clinical development strategy" following a pre-IND meeting with FDA regarding the company's KNX018 inhaled sensitizer for use with radiation therapy for the treatment of non-small cell lung cancer (NSCLC). The company said that it now plans to … [Read more...] about Kenox says it has completed pre-IND meeting with FDA regarding its inhaled sensitizer for lung cancer radiation therapy