Insulet (NSDQ:PODD) shares are under pressure this morning after the diabetes company missed expectations for its 4th-quarter earnings, despite beating Wall Street’s consensus sales forecast. Billerica, Mass.-based Insulet narrowed its losses by -66.6%, to -$9.1 million, or -16¢ per share, on sales growth of 23.6% to $103.6 million for the 3 months ended Dec. 31, compared […]
Allergan ticks up on Q4, 2016 beats
Allergan (NYSE: AGN) shares ticked up today after the company reported 4th-quarter and full-year earnings – and a 2017 sales forecast – that beat expectations on Wall Street. The drugmaker narrowed its losses by 90% to -$70.2 million, or -20¢ per share, on sales growth of 7.1% to $3.86 billion for the 3 months ended Dec. 31, […]
Baxter to pay $18m to settle moldy IV plant case
Baxter (NYSE:BAX) agreed to pay $18 million to settle criminal and civil cases stemming from a North Carolina sterile intravenous solution plant where mold was found in air filters. The agreement includes penalties and forfeitures of some $16 million and another $2.2 million to settle a civil qui tam lawsuit with the U.S. Justice Dept. Whistleblower Christopher Wall, […]
Grifols pays $51m for minority stake in Access Biologicals
Grifols (NSDQ:GRFS) said today that it paid $51 million for a 49% stake in Access Biologicals, in a deal that includes an option to acquire the rest of the business. That option, for the remaining 51% share in Vista, Calif.-based Access, goes live in 2022, Grifols said. The agreement also includes a provision to supply Access with non-human-use […]
UPDATE: BTG’s U.S. Biocompatibles business to pay $36m settlement, plead guilty to misbranding
Updated to include BTG’s guilty plea entered Nov 7. BTG (LON:BTG) said today that it agreed to pay the U.S. Justice Dept. $36 million (£28.4 million) to settle a probe into the marketing of the LC Bead embolization microspheres made by its Biocompatibles subsidiary. The company plead guilty on Monday, November 7, to charges of improperly marketing […]
FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]
Sanofi, Google’s Verily launch $500m Onduo diabetes JV
Sanofi (NYSE:SNY) and Verily Life Sciences, the healthcare play owned by Google parent Alphabet (NSDQ:GOOGL), are launching a joint venture to tackle diabetes. The Cambridge, Mass.-based Onduo JV will aim to combine Verily’s expertise in miniaturized electronics, analytics, and consumer software with Sanofi’s diabetes program. Dr. Joshua Riff, formerly senior vice president of prevention & wellbeing at UnitedHealth‘s (NYSE:UNH) Optum business, was tapped to be […]
Unilife: Ex-CEO Shortall’s shenanigans exposed ‘material weaknesses’
Shares in Unilife (NSDQ:UNIS) are off 7% this week after the company said its investigation into former CEO Alan Shortall turned up “material weaknesses” in its bookkeeping procedures that will require it to restate some of its financials. Shortall, who left the company in March along with COO Ramin Mojdeh, was elevated to chairman in 2013. In May, […]
Boehringer Ingelheim, Qualcomm team on connected inhaler
Boehringer Ingelheim Pharmaceuticals and Qualcomm (NSDQ:QCOM) subsidiary Qualcomm Life yesterday said they’re partnering to create an inhaler that can track user information, hoping to improve outcomes for chronic obstructive pulmonary disease. Boehringer tapped Qualcomm to create a low-power, disposable module for Boehringer’s Respimat inhaler, using Qualcomm’s 2net Design platform to build a wireless communication component into the inhaler. The […]
Intersect ENT claims reimbursement win for Propel drug-eluting sinus implant
Intersect ENT (NSDQ:XENT) said today that it won a positive coverage decision from CareFirst BlueCross BlueShield for its Propel and Propel Mini drug-eluting sinus implants. The devices are designed to elute the anti-inflammatory steroid mometasone furoate; Menlo Park, Calif.-based Intersect won FDA approval for the original Propel implant in August 2011 and for the Propel Mini the following September. The […]