Proveris Scientific, a specialist in aerosol drug delivery testing, announced that it has hired engineer Prateek Nath to "to design and build a wide variety of research-grade prototypes and run experiments on these prototypes to generate proof statements for scientific hypotheses related to aerosol science, human physiology, and drug delivery." Nath was most … [Read more...] about Proveris Scientific hires Prateek Nath as research scientist
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Nuformix gets notice of allowance for US patent covering its inhaled tranilast
Nuformix said that it has received a Notice of Allowance for US Patent Application No. 17/051,592 titled, "Crystalline Tranilast Salts and Their Pharmaceutical Use." The company has already been granted one patent covering crystalline forms of tranilast. According to Nuformix, pre-clinical studies of its NXP002 tranilast, which it is developing as a potential inhaled … [Read more...] about Nuformix gets notice of allowance for US patent covering its inhaled tranilast
Noveome announces Phase 1 results from study of intranasal ST266 in patients at risk of glaucoma
Noveome Biotherapeutics said that a Phase 1 safety study of its intranasal ST266 secretome in glaucoma suspect patients demonstrated no serious adverse events at doses up to 400 µL per day over 28 days. The open label study evaluated single doses of 200 µL daily for 14 days, two doses of 200 µL daily for 14 days, and two doses of 200 µL daily for 28 days. Noveome … [Read more...] about Noveome announces Phase 1 results from study of intranasal ST266 in patients at risk of glaucoma
FDA approves Sandoz albuterol MDI
The FDA is touting its June 1, 2021 approval of Sandoz's ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, "The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with … [Read more...] about FDA approves Sandoz albuterol MDI
Lupin launches authorized generic of Brovana inhalation solution in the US
Lupin has announced the US launch of an authorized generic version of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. The FDA tentatively approved the company's ANDA for the inhalation solution in April 2020. The FDA approved Brovana for the treatment of COPD in 2006, requiring a post-marketing safety study. In 2013, … [Read more...] about Lupin launches authorized generic of Brovana inhalation solution in the US
Evoke gets new US patent for Gimoti nasal spray
Evoke Pharma said that the United States Patent and Trademark Office (USPTO) has issued US patent No. 11,020,361 ("Nasal Formulations of Metoclopramide”) covering methods of use for Gimoti metoclopramide nasal spray for the treatment of gastroparesis until at least 2029. The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020. Evoke … [Read more...] about Evoke gets new US patent for Gimoti nasal spray
FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil
According to Liquidia, the FDA has accepted the company's resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the agency accepted the submission in April 2020 and then issued a complete response letter to the … [Read more...] about FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil
Proveris hires Maria L. Smith to head up business development for Proveris Laboratories
Aerosol testing specialist Proveris Scientific has named Maria L. Smith as Director, Application and Business Development for Proveris Laboratories. Smith has extensive experience in OINDP spray characterization, first at DPT Laboratories and then at Renaissance Lakewood. In addition to business development for the lab, she is expected to "serve as a liaison to … [Read more...] about Proveris hires Maria L. Smith to head up business development for Proveris Laboratories
Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid
Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma monitoring company called Respiri and then named a new CEO, its sixth chief executive since 2017, saying that it "must continue … [Read more...] about Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid
Noveome signs agreement for commercial use of SipNose intranasal device for delivery of ST266
Noveome Biotherapeutics has signed a commercial license agreement for the use of SipNose’s intranasal Cribriform Targeted Device (CT6) for delivery of its ST266 secretome for the treatment of ophthalmological and CNS conditions the companies said. Noveome has been working with SipNose since 2015 and used the device in a Phase 1 trial of ST266 for optic nerve disease … [Read more...] about Noveome signs agreement for commercial use of SipNose intranasal device for delivery of ST266