Ophthalmalogical developer Oculis said today it closed a Series A round of financing to support its solubilizing nanoparticle drug delivery platform, currently being designed to deliver drugs to treat diabetic macular edema. The company did not disclose the amount raised in the round. The SNP platform is designed to “solve the limitations of available eye-drop […]
Drug-Device Combinations
Taris launches another Phase I trial for bladder cancer drug-device combo
Taris Biomedical said today it is launching a new phase I trial of its TAR-200 gemcitabine releasing intravesical system designed to deliver drugs directly to the bladder for patients with non-muscle-invasive bladder cancer. The phase 1b open-label study is slated to enroll 30 patients to explore whether continuous, local exposure to gemcitabine using TAR-200 is […]
FDA draft guidance on 510(k)s omits combination devices
Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA. The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years […]
Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]
Amgen 2nd-quarter profit tops Street view, raises 2016 forecast
(Reuters) – Amgen (NSDQ:AMGN) on Wednesday reported higher-than-expected 2nd-quarter profit on increased sales of its blockbuster rheumatoid arthritis drug Enbrel and newer medicines, and the company again raised its full-year forecast. The forecast appeared to signal management’s confidence in the 2nd half of the year. The company is on track to meet or exceed its long-term objectives,” Chief […]
J&J’s Acclarent to pay $18m over off-label marketing charges
Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent will pay $18 million to resolve allegations over false claims submitted to Medicare and other federal health care programs in relation to marketing its Relieva Stratus MicroFlow sinus spacer as a drug-delivery device without FDA clearance. The company won FDA clearance in 2006 to market the Stratus as a […]
Bristol-Myers Squibb launches Orencia ClickJect drug-device combo for rheumatoid arthritis
Bristol-Myers Squibb said today it launched the Orencia ClickJect autoinjector designed for the self-administration of Orencia to treat moderate to severe rheumatoid arthritis. The Orencia ClickJect is designed to deliver 125 mg of subcutaneous Orencia through a push button operation with injection confirmation to reduce the possibility of user errors, the company said. “Today’s launch […]
BioCorRx launches R&D program for anti-addiction naltrexone drug-device combo
Anti-addiction developer BioCorRx said today it launched a research & development initiative as it seeks FDA approval for its naltrexone implant designed to treat opioid and alcohol addictions. The implant slowly releases naltrexone, a non-addictive opioid antagonist that can reduce physical cravings and block some of the effects of alcohol and opioids, the Los Angeles-based […]
Amgen taps West’s SmartDose for Pushtronex system
Amgen (NSDQ:AMGN) is partnering with West Pharmaceutical Services to integrate its SmartDose delivery platform into its Pushtronex system, the companies said today. The SmartDose technology is designed to adhere to a patient’s body, generally on the abdomen, and requires no patient operation during administration, the companies said. The technology includes integrated silicone-free Daikyo Crystal Zeniths’s cartridge […]
QT Vascular wins CE Mark for Chocolate Heart DCB
QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a paclitaxel-coated version of the Chocolate balloon that won FDA approval back in June 2014, the Singapore-based company said. “We are delighted with the CE […]
