Shares in Tandem Diabetes Care (NSDQ:TNDM) rose yesterday after the insulin pump maker beat expectations on Wall Street with its fourth quarter and full-year results. The San Diego Calif.-based company reeled in its losses in Q4, posting a net loss of -$11.4 million on sales of $40.3 million for the 3 months ended Dec. 31, for […]
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Aerie misses Q4 earnings estimates by 11¢
Shares in Aerie Pharmaceuticals (NSDQ:AERI) held steady today after the eye-drug maker missed earnings expectations on Wall Street with its fourth-quarter and full-year financial results. The Durham, N.C.-based company posted a net loss of -$58.5 million, or -$1.60 per share, for the 3 months ended Dec.31. Adjusted to exclude 1-time items, earnings per share were -$1.38, behind […]
FDA panel to review Senseonics’ implantable CGM this month
A panel for the FDA is slated to review Senseonics‘ (NYSE:SENS) premarket approval application for its Eversense implantable continuous glucose monitoring system on March 29. The company’s device sends glucose data every five minutes to a transmitter, which then communicates that information to a mobile app, displaying the values in the real-time. The Eversense system […]
Mylan: Generic competition pushes EpiPen sales down
Mylan (NSDQ:MYL) revealed in its annual report yesterday that EpiPen sales in the U.S. were down $655.4 million last year compared to 2016. The company, which faces continued backlash over the price of its emergency allergy treatment, cited the launch of a generic version of its device, higher governmental rebates and increased competition as reasons for […]
Sorrento Therapeutics wins FDA nod for post-shingles pain patch
Shares in Sorrento Therapeutics (NSDQ:SRNE) soared today after the company announced that the FDA approved its ZTlido lidocaine pain patch designed to treat patients with post-shingles neuralgia. The company resubmitted its application for ZTlido to the FDA last year after it was rejected by the U.S. regulatory agency in 2016. “ZTlido was designed to solve a […]
Study: Hill-Rom’s Metaneb System lowers risk of post-operative pulmonary complications
Researchers at the 47th Society of Critical Care Medicine reported this week that Hill-Rom‘s (NYSE:HRC) Metaneb System may help reduce the incidence of post-operative pulmonary complications in high-risk patients. A 419-patient study found that patients using the Metaneb System combined with standard respiratory therapy spent 1.6 fewer days in the hospital on average compared to […]
Intersect ENT posts Street-beating Q4, full-year sales, earnings
Shares in Intersect ENT (NSDQ:XENT) rose today after the medical device maker topped expectations on Wall Street with its fourth quarter and full-year financial results. The Menlo Park, Calif.-based company posted a net loss of -$3.2 million, or-11¢ per share, on sales of $29.5 million for the three months ended Dec. 31, for sales growth of […]
Dexcom beats The Street with Q4 sales, earnings
Dexcom (NSDQ:DXCM) beat expectations on Wall Street with its fourth quarter and full year financial results, growing its quarterly revenue 29% compared to the same period last year. The San Diego, Calif.-based company posted a net loss of -$9.4 million, or -11¢ per share, on sales of $221 million for the 3 months ended Dec. 31. […]
Facing legal woes, PixarBio takes aim at InVivo
PixarBio (OTC:PXRB) faces its own legal problems: a possible lawsuit by the SEC, legal action by a disgruntled employee who is demanding unpaid wages and former landlords looking for $1.8 million in unpaid rent. But the 7-person biotech is also looking to launch some litigation of its own, according to a recent document it filed with […]
EMA committee backs Amgen’s on-body injector for Neulasta
Amgen (NSDQ:AMGN) said today that a committee for the European Medicines Agency has recommended that the regulatory body approve a label variation for its Neulasta product to include the Onpro on-body injector delivery device. Neulasta’s Onpro kit includes a pre-filled syringe paired with a single-use on-body injector. The lightweight device is given to the patient on the […]