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 […]
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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 […]
Synlogic finalizes Mirna Therapeutics merger
Synlogic said today that it finished its merger with Mirna Therapeutics after the deal won approval from Mirna’s stockholders last week. The merged company, which will trade on the Nasdaq market under the symbol “SYBX”, is slated to advance Synlogic’s Synthetic Biotic medicines. The company’s platform uses synthetic biology to reprogram probiotic bacteria to treat […]
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 […]
FDA intervenes after stem cell center offers unproven treatment to cancer patients
The FDA is cracking down on stem cell clinics that administer unproven and potentially dangerous treatments to patients, citing a California-based clinic that the regulatory watchdog said was treating cancer patients with the smallpox vaccine. Last week, the U.S. Marshals Service seized five vials of a vaccine that is reserved only for people at high […]
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]
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 […]
Gilead expands into cell therapy with $11.9B Kite Pharma purchase
Taking a plunge into the cell therapy arena, Gilead Sciences (NSDQ:GILD) said today that it has inked an $11.9 billion deal to acquire Kite Pharma (NSDQ:KITE). The deal, which was unanimously approved by both companies’ boards, is slated to close in the fourth quarter of this year. Gilead said it plans to pay $180 in cash […]