Teva Pharmaceuticals (NYSE:TEVA) said this week that CEO Erez Vigodman has stepped down from their position at the head of the world’s biggest generic drugmaker. Vigodman’s exit from the company will take effect immediately, with board chair Yitzhak Peterburg taking on the interim role of chief exec. Israel-based Teva has seen shares plummet after a series of […]
Pulmatrix updates on $3m offering
Pulmatrix (NSDQ:PULM) today updated pricing on an upcoming $3.3 million offering, looking to float 950,000 shares at $3.50 per share. The company said it expects to collect $3.1 million after paying for placement agent fees, which it calculated at $216,125. H.C. Wainwright & Co are acting as exclusive placement agents for the offering, according to an […]
Intersect ENT dives on Q3 earnings, reimbursement concerns
Shares in Intersect ENT (NSDQ:XENT) yesterday tumbled over 30% over reimbursement woes, despite the medical device maker handily topping expectations on Wall Street with its 3rd quarter results. The company said that the Centers for Medicare & Medicaid Services released its 2017 Hospital Outpatient Final Rule, which included reimbursement rates for sinus surgery at a fixed amount 40-50% […]
OrthoSera wins CE Mark for hypACT regenerative osteoarthritis device
Orthobiologics company OrthoSera GmbH said today it won CE Mark approval in the European Union for its hypACT system designed to aid in regenerating osteoarthritic bone. The Austrian company’s hypACT device is designed to deliver its hyperacute, platelet rich plasma serum to aid in regeneration for patients with osteoarthritis and other degenerative diseases. “After the […]
Oculis raises unspecified amount in Series B for drug-device eye disease combo
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 […]
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 […]
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 […]