Bellerophon Therapeutics (NSDQ:BLPH) last week closed an underwritten public offering of 10,000,000 shares of common stock at 70¢ apiece. The Warren, N.J.-based company also gave underwriters a 45-day option to buy up to an additional 1,500,000 shares of common stock at the same price. The gross proceeds of the offering were $7 million, Bellerophon reported. Earlier […]
BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Using a contoured needle base and distributed pressure, the pen needle lessens the risk resulting from user injection force […]
Bellerophon prices $7m offering
Bellerophon Therapeutics (NSDQ:BLPH) said yesterday that it priced an underwritten public offering of 10,000,000 shares of its common stock at 70¢ apiece. The Warren, N.J.-based company also gave underwriters a 45-day option to buy an additional 1,500,000 shares of common stock at the same price. Bellerophon expects to reel in roughly $7 million in proceeds from […]
Docs plan industry collab to study paclitaxel devices
Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee applications. The initiative comes on the heels of a meta-analysis published in the Journal of the American Heart Association this month showing a potential link between […]
LINC 2019: Medtronic, Boston Scientific back paclitaxel devices amid safety probe
Amid concerns about a potential link between paclitaxel devices and heightened long-term mortality rates, Medtronic (NYSE:MDT) and other device-makers doubled down on their products’ safety at this year’s Leipzig Interventional Course in Germany. Medtronic presented a patient-level survival analysis that included 1,837 patients enrolled in its In.Pact Admiral clinical program. The analysis assessed all-cause mortality across […]
FDA takes big step toward over-the-counter naloxone
In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment. A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, […]
FDA probes paclitaxel-eluting stents, balloons
The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices. The agency is “evaluating” the new information presented by the study and recommended […]
Windgap Medical raises $12m for epinephrine auto-injector
Windgap Medical has raised $12 million from 106 investors as part of a $27 million round, according to a document filed with the SEC. The Watertown, Mass.-based company is developing an epinephrine auto-injector designed to treat severe allergic reactions. Windgap Medical is reportedly working on a product that can withstand harsh temperatures and can be […]
Johnson & Johnson, Apple ink collab for AFib study
Johnson & Johnson‘s (NYSE:JNJ) Janssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation. The study is slated to measure the impact of the Apple Watch […]
Sandoz launches PFS alternative to epinephrine auto-injector
Novartis (NYSE:NVS) division Sandoz said today that it launched its Symjepi epinephrine pre-filled syringe in the U.S. The company’s product is designed as an alternative to epinephrine auto-injectors to treat emergency allergic reactions. Sandoz described Symjepi as an “affordable” alternative to EpiPens but did not disclose the product’s price. “The Symjepi device is small in size and […]
