In June, Maryland became the 1st state to pass a law in an attempt to ban price gouging by generic pharmaceutical manufacturers. The bill passed without the governor’s signature, who took issue with the bill’s language. Governor Larry Hogan said that his chief counsel raised legal and constitutional concerns about the bill. Now, generic drug […]
Pharmaceuticals
Oramed to meet with FDA about late-stage clinical program for oral insulin capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31. Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo. […]
FDA accepts Axium’s orphan designation request for intranasal Truveta
Axium Pharmaceuticals said today that the FDA accepted its orphan designation request for the intranasal administration of lorazepam, Truveta, in the treatment of Lennox-Gastaut syndrome. The High Point, N.C.-based company is developing a novel intranasal administration device for new formulations of existing drugs. Axium said the device is designed to bring about rapid onset of […]
pSivida licenses European rights for Durasert to Alimera
pSivida (NSDQ:PSDV) said today that it restructured a deal with Alimera Sciences (NSDQ:ALIM) to grant Alimera rights to the Durasert three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa. Alimera, which holds an exclusive license to pSivida’s intravitreal implant, Iluvien, plans to apply for a secondary indication for Iluvien for posterior segment uveitis. […]
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
Study: Dangerous medication errors are on the rise
According to a study published in Clinical Toxicology, researchers from Nationwide Children’s Hospital found there was a 100% increase in the rate of serious medication errors per 100,000 U.S. residents between 2000 and 2012. The team analyzed calls to Poison Control Centers across the U.S. and discovered that medication errors, those that happen outside of […]
Defymed reveals development of novel insulin delivery device
France-based medtech company Defymed said today that it’s developing a novel insulin delivery device which it hopes to bring to market by the end of 2020. The company’s device, ExOlin, uses a biocompatible membrane that is nonbiodegradable and permeable to insulin, according to Defymed. The insulin delivery device is designed to be implanted into a […]
Inotek recalibrates after drug fails in glaucoma trial
Inotek Pharmaceuticals (NSDQ:ITEK) said last week that its glaucoma drug failed in a Phase II trial. This marks the 2nd problem for Inotek’s drug this year, after it failed in a late-stage trial comparing it to a placebo in January. In response to the data, CEO David Southwell said in a statement that the company […]
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
FDA clears first new sickle cell treatment in 20 years
Emmaus Life Sciences said last week that the FDA approved its L-glutamine oral powder, Endari, as a therapy to lessen the complications of sickle cell disease in patients ages 5 and older. The drug’s approval was supported by data from a Phase III trial evaluating Endari compared to a placebo in 230 adults and children […]