Express Scripts (NSDQ:ESRX) and other pharmacy benefit managers have been accused of giving Mylan‘s (NSDQ:MYL) EpiPens favorable placement on drug formularies in exchange for kickbacks, according to a proposed class action filed in Kansas federal court this week. The suit was brought by people covered under Employee Retirement Income Security Act benefit plans. These consumers claim […]
Featured
Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
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 […]
Nemaura develops medical grade diabetes management app
Nemaura Medical (OTC:NMRD) said today that it has finished development of a medical grade app designed to be used with the company’s SugarBeat continuous glucose monitoring system or with glucose meters. The mobile app, which was developed for android mobile devices, allows users to input their diet, medication and exercise information, as well as view […]
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 […]
MedGenome raises $30m for biomarker discovery program
Genomics research and diagnostics company MedGenome said today that it closed a $30 million Series C round led by Sequoia India and Sofina. Zodius Capital, the co-founder & former CEO of Infosys, Kris Gopalakrishnan, and former Cognizant CEO Lakshmi Narayanan also participated in the round. The Foster City, Calif.-based company said it plans to use […]
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 […]
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 […]