The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara's Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it expressed this opinion at the FDA's Rare Disease Day in February 2020 and is officially submitting … [Read more...] about Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
Regulatory
Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company's home state of South Carolina on March 17, 2020, describing the company's efforts to increase production of its inhalation solutions and suspensions to meet demand during the COVID-19 pandemic. Nephron produces its own inhalation products; including albuterol, ipratroprium bromide, … [Read more...] about Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Insmed has announced its submission of a new drug application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have not responded to other therapies sufficiently. Arikayce was approved by the … [Read more...] about Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing the LungFit BRO system for the treatment of bronchiolitis. The company said that if the FDA approves the IDE, it will conduct … [Read more...] about Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Fluidda’s Broncholab FRI platform cleared by FDA for clinical use
Functional respiratory imaging (FRI) company Fluidda announced that the FDA has cleared the company's Broncholab FRI platform for use in clinical settings. According to the company, Broncholab can provide much more accurate information about patient-specific regional lung function than conventional test methods like spirometry, allowing for better diagnosis and … [Read more...] about Fluidda’s Broncholab FRI platform cleared by FDA for clinical use
Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics
According to Senzer, the company has obtained the IND application and data package for its inhaled dronabinol from its former partner, Insys Therapeutics, and will now move ahead with development for the treatment of side effects from chemotherapy and for neuropathic pain. Insys filed for bankruptcy in June 2019. Senzer partnered with Insys in 2015 to develop … [Read more...] about Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics
FDA issues new and revised product specific guidances for a number of generic OINDPs
The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products, . One of the new guidances is for generic sumatriptan succinate nasal powder. Onzetra Xsail intranasal sumatriptan was approved by the FDA in January 2016 for … [Read more...] about FDA issues new and revised product specific guidances for a number of generic OINDPs
Virpax announces completion of pre-IND meeting for its intranasal enkephalin
Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company's NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology (MET) formulation licensed from Nanomerics and is delivered via a cartridge-based device. In January 2020, Virpax … [Read more...] about Virpax announces completion of pre-IND meeting for its intranasal enkephalin
EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma
GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta has been approved in Europe for the treatment of COPD since November 2017. A previous Type II variation application was approved in … [Read more...] about EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma
FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)
The FDA has announced the approval of Perrigo's ANDA for a generic of Teva's ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for the generic version of ProAir HFA in 2012; Teva responded with a patent infringement suit. In 2014, the companies reached a settlement that would give Perrigo … [Read more...] about FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)