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Aradigm’s NDA for Linhaliq gets priority review status from FDA

According to Aradigm Corporation, the FDA has accepted its NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients for priority review. The agency set a PDUFA date of January 26, 2018. Aradigm announced its submission of the NDA in July 2017. Linhaliq … [Read more...] about Aradigm’s NDA for Linhaliq gets priority review status from FDA

4D Molecular Therapeutics gets $3 million from CFFT for development of aerosol gene therapy

4D Molecular Therapeutics (4DMT) has received $3 million from Cystic Fibrosis Foundation Therapeutics (CFFT) for development of 4D-710, an aerosolized adeno-associated virus (AAV) gene therapy vector that will deliver a functional copy of the CFTR gene to the lungs of CF patients, the company said. The funding will be used for completion of studies to support an … [Read more...] about 4D Molecular Therapeutics gets $3 million from CFFT for development of aerosol gene therapy

Emergent BioSolutions gets BARDA grant worth up to $63 million for development of intranasal cyanide antidote

The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded a grant worth up to $63 million to Emergent BioSolutions for development of a single-use stabilized isoamyl nitrite (SIAN) nasal spray for the treatment of acute cyanide poisoning. The initial 17-month, $12.7 million agreement will cover … [Read more...] about Emergent BioSolutions gets BARDA grant worth up to $63 million for development of intranasal cyanide antidote

Trelegy Ellipta approved by the FDA

GlaxoSmithKline announced that its NDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD has been approved by the FDA. GSK said that Trelegy Ellipta should be available to patients in the US "shortly." The FDA approval comes days after the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion … [Read more...] about Trelegy Ellipta approved by the FDA

Optinose’s Xhance fluticasone propionate nasal spray gets FDA approval

The FDA has approved Optinose's Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company's exhalation delivery technology, should be available in the US by mid-2018. In January 2017, OptiNose announced that the FDA had accepted its NDA for OPN-375. The company had … [Read more...] about Optinose’s Xhance fluticasone propionate nasal spray gets FDA approval

Mundipharma’s Nyxoid naloxone nasal spray gets positive opinion from CHMP

The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma's MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose. Currently, no intranasal naloxone formulations are approved for use across the entire EU. Indivior's Nalscue nasal spray was approved in France in July 2017. Adapt Pharma submitted an MAA … [Read more...] about Mundipharma’s Nyxoid naloxone nasal spray gets positive opinion from CHMP

CHMP issues positive opinion regarding GSK’s Trelegy Ellipta triple combination DPI

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK's MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients whose symptoms are not adequately controlled by an ICS/LABA combination. GSK plans to market the product in Europe … [Read more...] about CHMP issues positive opinion regarding GSK’s Trelegy Ellipta triple combination DPI