Liquidia has announced the resubmission of its NDA for LIQ861 dry powder treprostinil for the treatment of pulmonary arterial hypertension, with the addition of CMC and device data requested by the FDA. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the FDA accepted the submission for review in April 2020; and in November 2020, the agency issued a … [Read more...] about Liquidia resubmits NDA for LIQ861 treprostinil DPI
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Pulmatrix says Cipla has breached a 2019 development agreement for Pulmazole intraconazole DPI
A month after regaining rights to PUR1800 and other inhaled narrow spectrum kinase inhibitors from Johnson & Johnson, Pulmatrix has announced that it may also reacquire the rights to its Pulmazole intraconazole DPI (PUR 1900). According to the company's business update, Pulmatrix recently notified Cipla that Cipla breached a 2019 development and commercialization … [Read more...] about Pulmatrix says Cipla has breached a 2019 development agreement for Pulmazole intraconazole DPI
Proveris Scientific adds services for unit dose nasal spray testing
Proveris Scientific has announced that it now has the ability to conduct in vitro testing of unit dose nasal drugs in multiple orientations, which is necessary for intranasal products such as opioid overdose reversal drugs, seizure medications, or sedatives that are designed for administration by emergency personnel or clinicians where the patients could be in various … [Read more...] about Proveris Scientific adds services for unit dose nasal spray testing
Vectura to develop inhaled formulation of Inspira candidate for the treatment of COVID-19
Inhalation CDMO Vectura has signed an agreement with Inspira Pharmaceuticals to develop an inhaled formulation of a plant extract Inspira is developing for the treatment of COVID-19, the company said. Vectura will create a version of the IPX formulation to be delivered via Vectura's Fox vibrating mesh nebulizer for Phase 1 trials. Inspira is looking to raise £350,000 … [Read more...] about Vectura to develop inhaled formulation of Inspira candidate for the treatment of COVID-19
Oxford Lasers contract services facility gets ISO/IEC 17025:2017 accreditation
Oxford Lasers has announced that its Didcot, UK contract services facility has received ISO/IEC 17025:2017 accreditation from the UK Accreditation Service. The company opened the imaging facility for contract testing of aerosol delivery devices in 2019 and expanded the facility in 2020. Seamus Murphy, Manager of the Imaging Division, commented, “The UKAS … [Read more...] about Oxford Lasers contract services facility gets ISO/IEC 17025:2017 accreditation
Glenmark launches Ryaltris-AZ nasal spray in India
Glenmark Pharmaceuticals has announced the launch of Ryaltris-AZ mometasone furoate / azelastine nasal spray for the treatment of allergic rhinitis in India, touting the low cost of the nasal spray compared to similar products. According to Glenmark, Ryaltris-AZ is priced at slightly less than half the cost of "the average price of the top 10 brands of the similar … [Read more...] about Glenmark launches Ryaltris-AZ nasal spray in India
FDA approves Hikma’s Kloxxado naloxone nasal spray
The FDA has approved a 505(b)(2) NDA for Hikma's Kloxxado naloxone nasal spray for the reversal of opioid overdose. Hikma says that it expects to launch the nasal spray, which was approved for use in pediatric and adult patients, in the second half of this year. Kloxxado delivers 8 mg of naloxone per dose, twice as much as the higher dose of Narcan naloxone nasal … [Read more...] about FDA approves Hikma’s Kloxxado naloxone nasal spray
DDL 2021 issues call for papers for virtual conference
The organizers of DDL 2021 have announced that the Drug Delivery to the Lungs meeting will once again take place online due to the COVID-19 pandemic, and they have issued a call for papers for the virtual conference. In addition, nominations are now open for the Pat Burnell Young Investigator Award and for the Emerging Scientist Award. The meeting will take place … [Read more...] about DDL 2021 issues call for papers for virtual conference
Health Canada approves the Syqe medical cannabis inhaler
Health Canada has approved Syqe Medical's metered dose medical cannabis inhaler, the company said. The Syqe inhaler, which uses a cartridge pre-loaded with granulated cannabis, has been available to patients in Israel since June 2019. In September 2019, the company announced that it had signed a deal with TerrAscend for distribution of the device in … [Read more...] about Health Canada approves the Syqe medical cannabis inhaler
Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Ampio Pharmaceuticals has announced that the final results from the AP-014 Phase 1 trial of inhaled Ampion in COVID-19 patients demonstrated a greater reduction in all-cause mortality than was seen in the preliminary results. In March 2021, Ampio reported that preliminary data from the trial showed a 62% reduction in all-cause mortality. After all patients completed … [Read more...] about Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality