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 […]
Drug-Device Combinations
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 […]
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 […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
Primatene Mist Inhaler rejected by FDA
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba. CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on […]
Researchers develop flexible patch with stainless steel microneedles
Researchers from the KTH Royal Institute of Technology in Stockholm have developed a patch that combines stainless steel microneedles and a soft polymer base. The team’s work was published this month in PLOS ONE. “To the best of our knowledge, flexible and stretchable patches with arrays of sharp and stiff microneedles have not been demonstrated to date,” […]
Another warning for CareFusion’s Alaris drug pump
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using […]