Shares in SurModics (NSDQ:SRDX) fell today after the medical device maker missed earnings expectations on Wall Street with its 2nd quarter results and narrowed its full-year outlook. The Eden Prairie, Minn.-based company posted profits of $506,000, or 4¢ per share, on sales of $17.5 million for the 3 months ended March 31, for bottom-line loss of […]
Drug-Device Combinations
Bankrupt Unilife asks judge for $1m in bonuses for top execs
Unilife (NSDQ:UNIS), which filed for Chapter 11 bankruptcy earlier this month, reportedly asked a Delaware bankruptcy court yesterday to approve a “key employee retention plan” that would provide 4 top executives with nearly $1 million in bonuses, contingent upon a successful sale of the company. Unilife added it has already approved the plan with its debtor-in-possession lender. The […]
New GSK chief exec: Fewer, more focused drug programs as generic competition looms
In her 1st comments since taking the helm on April 1st, GlaxoSmithKline‘s (NYSE:GSK) new chief executive Emma Walmsley said that her priority is the company’s pharmaceuticals unit, where she wants to lead fewer but bigger new drug launches. “We’d like to have probably fewer and more focused priorities, to have bigger launches,” she told reporters, according […]
ProSolus invests in manufacturing capacity for transdermal drug delivery tech
Mission Pharmacal subsidiary ProSolus Inc. said this week that it expanded its manufacturing capabilities and commercialization efforts for transdermal drug delivery technologies. The Miami-based company, which develops and manufactures transdermal and trans-mucosal drug delivery products, installed a 2nd transdermal production facility in Boerne, Texas. The new location has a larger production line than the Miami […]
Mercator enrolls first patient in BTK vascular disease trial
Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia. The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications […]
United Therapeutics misses estimates for Q1 rev, earnings
Shares in United Therapeutics (NSDQ:UTHR) fell today after the biotech company missed expectations on Wall Street with its 1st quarter results. The Silver Spring, Md.-based company posted profits of $178.6 million, or $3.89 per share, on sales of $370.5 million for the 3 months ended March 31, for bottom-line loss of -24% on sales growth of 0.4% compared […]
Sanofi, Regeneron win FDA nod for once-monthly cholesterol injection
Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) said today that the FDA approved the companies’ new supplemental Biologics License Application for a once-monthly, 300 milligram dose of Praluent as a treatment for adults with high low-density lipoprotein cholesterol. The 300 milligram dose is administered using 2 pre-filled pens that each deliver 150 milligrams at an injection site. The […]
Reva plans $40m convertible note offering
Reva Medical (ASX:RVA) said yesterday that it’s planning a $40 million convertible note offering with several institutional and 1 undisclosed corporate investor to fund the company’s ongoing needs, including the clinical development of its Fantom sirolimus-eluting bioresorbable coronary scaffold. Upon issuance of the convertible notes, the company is slated to receive $32.5 in net cash […]
Medtronic touts drug-coated balloon in peripheral artery disease patients
Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London. Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with […]
Portal wins ISO certification for needle-free drug delivery device
Medical device start-up Portal Instruments said today that it won ISO 13485:2012 certification from the National Standards Authority of Ireland. The Cambridge, Mass.-based company is developing a hand-held, needle-free drug delivery device. The device can precisely administer high viscosity biologics directly through the skin using a collimated jet that is the size of a strand […]