Calls for papers
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ReCode Therapeutics, which is developing inhaled mRNA therapies, announced that Heather Clark will succeed Shehnaaz Suliman as the company’s CEO, with Suliman becoming executive chair of the board. Clark joined ReCode in 2022 and has… Read more . . .
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US-based opthalmic pharmaceuticals company Harrow announced that it will pay Viatris $30 million up front and up to $70 million in milestone payments to acquire Tyrvaya varenicline nasal spray. Tyrvaya was approved by the FDA… Read more . . .
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Savara has announced that the European Patent Office and the Australian Patent Office have issued new patents covering Molbreevi molgramostim inhalation solution. Both the European patent, No.4121000, and the Australian patent, No. 62/990,810, protect Molbreevi… Read more . . .
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MannKind Corporation announced that the Phase 1b INFLO-1 safety and tolerability trial of its nintedanib dry powder inhaler met its primary endpoint, demonstrating safety and tolerability. The multiple ascending dose study enrolled 27 patients with… Read more . . .
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Intranasal drug developer Nasus Pharma announced that it has hired former Teva USA President and CEO Brendan O’Grady as its new CEO. O’Grady was most recently CEO of Assertio Holdings and was previously CEO of… Read more . . .
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Gossamer Bio announced that it has reacquired the ex-US rights to its seralutinib dry powder inhaler for the treatment of pulmonary hypertension from Chiesi, which acquired the rights to the seralutinib DPI in 2024. According to… Read more . . .
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US-based biopharm Revagenix announced that it has initiated a Phase 1 trial of Rev-56, which it describes as an “inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (NCFB).” The first part of the study will evaluate… Read more . . .
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According to Cipla, the FDA has approved the company’s ANDA for 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths of its generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of… Read more . . .
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According to Cessatech, the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Proveca’s pediatric-use marketing authorization (PUMA) of KemSu (CT001) sufentanil / ketamine nasal spray for the treatment of… Read more . . .
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According to Aptar Pharma, parent company of OINDP-focused CRO Nanopharm, the UK Medicines and Healthcare Products Regulatory Agency has completed an inspection of Nanopharm’s facility in Cwmbran, Wales and has certified the location as GMP compliant.… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA