Keystone Nano said today that the FDA approved its investigational new drug application for the ceramide nanoliposome as a treatment for solid tumors. The company will launch a phase I trial at 3 sites to evaluate safe dosing levels and the product’s efficacy as a cancer therapy. Ceramide is a lipid that has demonstrated efficacy in […]
Clearside Biomedical names Beckman as new CMO | Personnel Moves, Jan. 5, 2017
Clearside Biomedical (NSDQ:CLSD) today named Dr. Richard Beckman as chief medical officer. Beckman is an ophthalmologist with 13 years of clinical practice under his belt, as well as 20 years of corporate executive and consultancy experience. Prior to joining Clearside, Beckman managed a pharmaceutical and medical device industry consulting firm. He has also served as […]
Apligraf cell therapy changes genomic profile of chronic wound
Organogenesis Inc. said yesterday that its wound-healing cell therapy Apligraf is the 1st of its kind to significantly change the genomic profile of a treated chronic wound. The claim was supported by new research done at the University of Miami and published in the journal Science Translational Medicine. The team applied Apligraf to a chronic venous leg […]
Scientists develop silver-releasing scaffold to prevent MRSA infection in bone
Researchers have developed a biocompatible, silver-releasing scaffold that inhibits infection from methicillin-resistant Staphylococcus aureus, or MRSA, in bone. The team’s work was published in Tissue Engineering. The antimicrobial properties of silver ions and the biodegradable scaffold seeded with bone-forming stem cells could be used to coat implants and prevent bone infection, the team suggested in the study. […]
Penn State researchers use immune cells to deliver cancer drugs
Researchers from the Penn State Materials Research Institute have developed a biodegradable and photoluminescent nanoparticle that are carried by immune cells to target melanoma. The team’s work was published last week in the journal Small. “The traditional way to deliver drugs to tumors is to put the drug inside some type of nanoparticle and inject those […]
scPharmaceuticals closes $46m Series B round
scPharmaceuticals said today that it closed a $45.6 million Series B round, co-led by OrbiMed and a subsidiary of Sun Pharmaceutical Industries. Other investors included 5AM Ventures and Lundbeckfond Ventures. The investment will be used to support the development of the operational and commercial infrastructure needed to bring Furoscix and the sc2Wear Infusor to market […]
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit […]
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
FDA accepts Allergan’s new drug application for Liletta contraception device
Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
Braeburn Pharmaceuticals files plans for $150m IPO
Braeburn Pharmaceuticals filed plans for a $150 million initial public offering last week with the Securities & Exchange Commission, leaving out any specific pricing details. The Princeton, N.J.-based company plans to list its shares on the Nasdaq market under the symbol “BBRX”. JPMorgan, Merrill Lynch and Deustche Bank are underwriters for the offering and Apple […]