Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion management software, enabling clinicians to deploy updates and drug libraries to all pumps simultaneously, as well as remotely manage device performance and monitor drug dosing. The […]
Drug-Device Combinations
Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for […]
Sorrento seeks FDA nod for lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) said today that its subsidiary Scilex Pharmaceuticals resubmitted the new drug application for its lidocaine patch, ZTlido, to the FDA. The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia. “We are excited about the opportunity to bring to the market a product that […]
BioDelivery Sciences president, CEO Sirgo to retire | Personnel Moves – Aug 29, 2017
BioDelivery Sciences (NSDQ:BDSI) said last week that its president & CEO, Mark Sirgo, plans to retire at the end of this year. Sirgo has held the corner office at the Raleigh, N.C.-based company since 2005. He will stay on as vice chairman of the board and will help determine his successor, BioDelivery Sciences reported. “After thirteen […]
Delcath readies for reverse stock split
Delcath Systems (NSDQ:DCTH) said today that it inked a deal to extinguish its 2016 convertible notes with the unnamed holder of the majority of the notes. But the agreement is contingent upon the company effecting a reverse stock split – a move that shareholders voted down in June. The company’s board urged shareholders to this time […]
Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study
Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared […]
Bard lands new indication for its drug-coated balloon
C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
Tandem Diabetes wins FDA nod for insulin pump with Dexcom’s CGM
Tandem Diabetes Care (NSDQ:TNDM) said today that the FDA approved its t:slim X2 insulin pump with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The regulatory win makes the device the first sensor-augmented insulin pump cleared to let users make treatment decisions without pricking their finger, the company touted. The San Diego, Calif.-based company said that the […]
FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks
The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke. The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the […]
Federal judge dismisses faulty birth control suit against Merck
A Maine federal judge tossed out a woman’s lawsuit against Merck (NYSE:MRK), after she claimed that the company’s Nexplanon birth control implant allegedly failed to keep her from becoming pregnant. Kayla Doherty filed the suit in April 2015, seeking damages related to the costs of raising a child as a single mother and costs related to […]