Spyryx Biosciences has presented data from preclinical studies of its SPX-101 inhaled SPLUNC1-derived peptide showing that SPX-101 improves mucus clearance and survival in animal models of cystic fibrosis and demonstrated no toxicity. The data were presented in three posters at the North American Cystic Fibrosis Conference. According to the company, nebulized … [Read more...] about Spyryx Biosciences presents data from preclinical studies of SPX-101
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Cohero Health closes $9 million financing round
Connected device company Cohero Health has closed a $9M Series A financing round to fund development of its BreatheSmart platform, business development, and clinical trials, the company said. One of the company's new investors is Heitkamp & Thumann Group, parent company of H&T Presspart, which is partnered with Cohero Health on an eMDI. Other Investors include … [Read more...] about Cohero Health closes $9 million financing round
Savara Pharmaceuticals appoints David L. Lowrance as CFO
Inhaled drug developer Savara Pharmaceuticals has announced the appointment of former Edgemont Pharmaceuticals CFO David L. Lowrance as its new Chief Financial Officer. Savara cited Lowrance's experience leading IPOs for Acucela, where he was CFO and Secretary, and Cumberland Pharmaceuticals, where he was VP and CFO. Savara Chairman and CEO Rob Neville commented, … [Read more...] about Savara Pharmaceuticals appoints David L. Lowrance as CFO
Arch Biopartners announces preparations for Phase 1 and 2 trials of AB569
Arch Biopartners has announced that Dr. Ralph Panos of the Cincinnati Veterans Affairs Medical Center (CVAMC) will prepare a protocol for human trials of the company's AB569 inhaled bactericide and will subsequently prepare an application to conduct the trials. The company expects that the application will be submitted to the IRB of the CVAMC by December 2016, … [Read more...] about Arch Biopartners announces preparations for Phase 1 and 2 trials of AB569
Upsher-Smith reports results from Phase 1 study of midazolam nasal spray in children
Upsher-Smith Laboratories has presented data from a Phase 1 study of its USL261 midazolam nasal spray in children with epilepsy demonstrating that the median Tmax for 1.25 mg, 2.5 mg and 5 mg single doses was ~15 minutes and Cmax was not dose dependent. According to the company, the FDA has granted both fast track and orphan drug designations to USL261 for rescue … [Read more...] about Upsher-Smith reports results from Phase 1 study of midazolam nasal spray in children
Sandoz files citizen petition challenging FDA Advair bioequivalence recommendations
Fierce Pharma has published a copy of a citizen petition filed by Sandoz that challenges the FDA's recommendations for establishing bioequivalence for generic copies of Advair Diskus 100/50. The FDA published the draft guidance for fluticasone propionate/salmeterol xinafoate in September 2013. The Sandoz citizen petition, submitted October 13, 2016, contends that … [Read more...] about Sandoz files citizen petition challenging FDA Advair bioequivalence recommendations
Windtree Therapeutics announces data from deposition study using its aerosol delivery system
Windtree Therapeutics has announced that a lung deposition study in cynomolgus macaques showed that its proprietary aerosol delivery system (ADS) delivered KL4 surfactant uniformly to all regions of the lung. The ADS is being developed to deliver Windtree's Aerosurf inhaled lucinactant, which is in Phase 2 development for the treatment of respiratory distress syndrome … [Read more...] about Windtree Therapeutics announces data from deposition study using its aerosol delivery system
Eurocine Vaccines begins Phase 1/2 study of intranasal flu vaccine
Eurocine Vaccines has started a Phase 1/2 clinical study of its Immunose FLU intranasal quadrivalent influenza vaccine, which uses the company's Endocine adjuvent and inactivated split antigens, the company said. Results should be available in mid-2017. Eurocine Vaccines Chief Scientific Officer Anna-Karin Maltais said, "We are very pleased that our nasal influenza … [Read more...] about Eurocine Vaccines begins Phase 1/2 study of intranasal flu vaccine
FDA committee recommends approval of Allergan’s SER120 desmopressin nasal spray
The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has voted to recommend approval of Allergan's SER120 desmopressin nasal spray for the treatment of nocturia (needing to wake up to urinate at night) in adults. The vote was 17-1 on the question of whether at least one of the SER120 doses is effective and 14-4 on the question of whether the … [Read more...] about FDA committee recommends approval of Allergan’s SER120 desmopressin nasal spray
Adherium gets US patent for inhaler monitoring device with dose counter
The US Patent and Trademark Office (USPTO) has granted SmartInhaler maker Adherium Limited US Patent No. 9,468,729, titled "Releasable monitor with optical dose counter for a medicament inhaler, the company announced, saying that, "This patent confirms Adherium’s ongoing commitment to innovation in the medication adherence market." According to Adherium, the … [Read more...] about Adherium gets US patent for inhaler monitoring device with dose counter