EnteroMedics (NSDQ:ETRM) priced today its underwritten public offering at $16.5 million, offering class A units priced at $5.31 apiece and class B units at $1,000 apiece. Each class A unit consists of 1 share of common stock and a 5-year warrant to purchase 1 share of common stock with an exercise price of $5.84 per […]
FDA issues guidance for off-label communications for drugs & devices
The FDA issued 2 draft guidances today to clarify the federal watchdog’s recommendations for communications regarding medical products, including off-label information and communicating cost-effectiveness data to payors for investigational drugs and devices that are not yet approved for use. “Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information […]
Corindus jumps on raised outlook
Shares in Corindus Vascular Robotics (OTC:CVRS) jumped nearly 11% in morning trading today after the company raised its outlook for full-year revenue in 2017 to between $13 million – $15 million. Analysts have pegged the robotic-assisted systems maker’s full-year revenue for 2017 at $12 million. Corindus said in a report yesterday that it anticipates implementation of at least […]
Sanofi’s Suliqua combination therapy approved in European Union
Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control. Suliqua will be available in 2 pre-filled SoloSTAR pens at […]
Orthofix to pay $14m to settle foreign bribery beef with SEC
The SEC said today that Orthofix (NSDQ:OFIX) has agreed to cough up more than $14 million to settle federal charges that it improperly booked revenue and made improper payments to doctors at government-owned hospitals in Brazil to increase sales. According to the SEC, the Texas-based medical device company improperly recorded some revenue as soon as a […]
Braeburn sets terms for $150m IPO
Braeburn Pharmaceuticals said today that it plans to raise $150 million by offering 7,692,308 shares of its common stock. The Princeton, N.J.-based company wrote in regulatory filings that it expects the initial public offering price for its stock to be between $18.00 and $21.00 apiece. Apple Tree Partners has indicated an interest in buying $50 million of shares […]
Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor
Edwards Lifesciences (NYSE:EW) said yesterday that it won CE Mark approval in the European Union for its HemoSphere blood flow monitor. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The device includes visual clinical support screens […]
Abbott launches dorsal root ganglion neurostim system in Europe
Abbott (NYSE:ABT) said today that it launched its Proclaim dorsal root ganglion neurostimulation system in Europe for patients suffering from chronic neuropathic pain. The Abbott Park, Il.-based company’s system targets sensory nerves packed within the dorsal root ganglion to directly target the area of the body where pain occurs and provide stronger pain relief compared […]
Derma Sciences pays $13m for Medihoney ahead of Integra buyout
Derma Sciences (NSDQ:DSCI) said last week that it paid $13.3 million for Medihoney, on the same day that Integra LifeSciences (NSDQ:IART) agreed to pay nearly $200 million for the tissue regeneration company. Prior to the acquisition, Derma Sciences held the exclusive global license for the Comvita-owned Medihoney brand and patents. Medihoney is eligible to receive an additional […]
Allergan pays $15m for failing to disclose Actavis ‘white knight’ offer
The SEC said yesterday that Allergan (NYSE:AGN) will pay a $15 million fine for failing to disclose its 2014 merger talks with Actavis. In June 2014, Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) offered a tender bid for the Irvine, Calif.-based company which was followed by a 7 month-long hostile pursuit by Valeant and co-bidder Pershing Square Capital Management. In November […]
Pulmatrix shares soar after winning FDA designation
Pulmatrix (NSDQ:PULM) shares were up 159% to $1.79 apiece in mid-afternoon trading today after the company announced that its drug candidate for treating fungal infections in the lungs of cystric fibrosis patients was designated as a ‘qualified infectious disease product’ by the FDA. With the designation, the Lexington, Mass.-based company will receive 5 years of […]