Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients.
Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. Insulin list prices regularly increase by double digits annually, according to the FDA, which attributed the price hikes to a lack of competition.
Get the full story on our sister site, Drug Delivery Business. (Source: Mass Device)
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Diabetes Featured Food & Drug Administration (FDA) News Well Pharma Pharmaceuticals Regulatory/Compliance Cigna Eli Lilly & Co. Express Scripts Novo Nordisk Sanofi Source Type: news
Report: Smith & Nephew IT worker helps police nab laptop thief
An IT worker at a Smith & Nephew (NYSE:SNN) facility in North Attleboro, Mass. has aided officials in arresting a man accused of breaking into six businesses in the area and stealing laptops and other items, according to a report from the Mansfield News.
The suspect, 56-year-old Reginald Shepard, allegedly began breaking into businesses in the Mansfield industrial park last August, with the first theft reported as having occurred at Alpha Analytical Labs on August 31. Three more break-ins were reported to have occurred on November 12, according to the report.
Shepard and his vehicle were identified using surveillance ...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Smith & Nephew Source Type: news
FDA accepts second application for Ocular Therapeutix ’ s drug-delivering implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery.
The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.
Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance oculartherapeutix Source Type: news
Obalon to lay off half its workforce in retail pivot
Obalon Therapeutics (NSDQ:OBLN) said today that it’s planning to lay off 50% of its employees, including all of its direct sales force, in a pivot toward retail.
The Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, said it hopes to cut its expenses by 35% during the second quarter after one-time charges of $1 million. The move also involves elimination of 49 direct field sales and headquarters emnployees, Obalon said. The company employed 100 full-time workers as of Dec. 31, 2019, according to a regulatory filing.
“As a result, the company expects to transition to a ne...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Wall Street Beat Weight loss Obalon Therapeutics Source Type: news
ReShape taps Allergan vet Bandy for CEO | Personnel Moves, April 3 2019
ReShape Lifesciences (NSDQ:RSLS) said last week that it named Allergan (NYSE: AGN) veteran Barton Bandy to replace Dan Gladney in the corner office, effective April 1.
Gladney, who announced his retirement in January, is staying on as chairman. Bandy spent a decade at Inamed until its $3.2 billion purchase by Allergan in 2005.
“I am very pleased to welcome Bart to the ReShape team. His experience and success – particularly with the Lap-Band business at Inamed and Allergan – in addition to his leadership track record since then make Bart the perfect next leader for ReShape,” Gladney said in prepared remarks....
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Featured Alcon Bio-Rad Dept. of Health & Human Services (HHS) ExsoMed FDA iCad Inc. McKesson Novartis Personnel Moves polarityte ReShape Lifesciences Stryker Source Type: news
Silk Road Medical upsizes IPO
Silk Road Medical today boosted the size of its pending initial public offering to as much as $120 million.
When it registered the IPO in March, Silk Road said it could fetch as much as $86 million. But last week the Sunnyvale, Calif.-based company cut the range, saying it planned to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Today Silk Road said it plans to offer 6 million shares at $19 to $20 a piece, which would deliver gross proceeds of $114 million to $120 million. The company developed the Enroute transcarotid stent and neuroprotection system to treat c...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Wall Street Beat Silk Road Medical Inc. Source Type: news
FDA wants public input on AI-enabled device regulation
(Image from FDA)
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback.
To date, the agency has cleared or approved AI/ML-assisted devices whose algorithms have typically been locked before hitting the market. The FDA’s 20-page discussion paper includes a proposed regulatory framework for devices that have algorithms that can ...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Big Data Blog Food & Drug Administration (FDA) News Well Regulatory/Compliance Software / IT internationalmedicaldeviceregulatorsforum Source Type: news
Endologix inks debt refinancing deal, looks to raise $52m
Endologix (NSDQ:ELGX) said today that it is looking to raise $52 million in a new offering of its common shares and that it inked debt exchange agreements with certain holders of its senior convertible notes.
In its private placement deal, the Irvine, Calif.-based company said it plans to float approximately 7.9 million new shares of its common stock at a price of $6.61 per share.
Endologix said it expects to collect approximately $49 million after payment of fees and expenses, and that the money will be used to support working capital and general corporate purposes.
The company said that it also entered into an exchange ...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Endologix Source Type: news
Teva wins EU nod for Ajovy migraine prophylactic
Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.
The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.
Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: Neurological Pharmaceuticals Regulatory/Compliance Teva Pharmaceuticals Source Type: news
What a new FDA commissioner could mean for clinical research
With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials.
During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels and banning menthol in cigarettes. He also oversaw the approval of a record number of new medicines, generic drugs and medical devices.
Yet his departure leaves many questions unanswered, especially those that impact the medical dev...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
AngioDynamics slides on fiscal Q3 misses
AngioDynamics (NSDQ:ANGO) shares are down today after the medical device company missed the mark with its fiscal third-quarter sales and earnings.
Profits were nearly halved for Latham, N.Y.-based AngioDynamics during the three months ended Feb. 28, falling some -94.3% to $796,000, or 2¢ per share compared with Q3 2018. Sales grew 3.0% to $86.3 million compared with the same period last year.
Adjusted to exclude one-time items, earnings per share were 19¢, 2¢ below the consensus estimate on Wall Street, where analysts were looking for revenues of $88.3 million.
“While we had pockets of softness in our financial perfo...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat AngioDynamics Source Type: news
Channel Medsystems wins PMA for Cerene cryoablation device
Channel Medsystems last week won pre-market approval from the FDA for its Cerene endometrial cryoablation device, starting the clock on a mandatory three-year post-approval study.
Cerene, which is designed to treat heavy but benign bleeding in premenopausal women for whom child bearing is complete, won CE Mark approval in the European Union in June 2017. The PMA granted March 28 is based on 12-month data from the 242-patient Clarity pivotal trial, which must now be extended for another 36 months, according to the FDA.
Emeryville, Calif.-based Channel Medsystems must follow at least 85% of Clarity patients out to three ye...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Boston Scientific Channel Medsystems Source Type: news
Report: Drones are delivering blood samples in N.C.
Autonomous drones have begun to ferry blood samples between clinics and labs in the skies over North Carolina, according to a recent report from Wired.
The drone service, run by UPS with drone technology from Matternet, made its first flight last Tuesday at Raleigh’s WakeMed Hospital, according to the report.
The drone can carry up to five pounds and completes its flight in approximately three minutes, a significant reduction from the 30 minutes it would take for a driver to make the journey by car, according to Wired.
While the drone is designed to work autonomously, all flights are monitored by a remote pilot-in-comman...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Cardiac Assist Devices UPS Source Type: news
J & J ’ s Ethicon warns EMEA docs on Intraluminal stapler issues
Johnson & Johnson‘s (NYSE:JNJ) Ethicon subsidiary late last month released a notice it filed in the Europe, the Middle East and Africa region warning of issues with its Intraluminal Staplers related to malformed staples and uncut washers that can “compromise staple line integrity.”
The company said that it initiated a medical device field safety corrective action for 378 lots of Intraluminal Staplers distributed in the region and that after investigating the complaints it found uncut washers and malformed staples in the devices.
“If a problem with the staple line is not adequately addressed or i...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Recalls Regulatory/Compliance Surgical johnsonandjohnson Source Type: news
Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication
Apyx Medical (NYSE:APYX), formerly known as Bovie Medical, said late yesterday that it has voluntarily withdrawn the FDA 510(k) clearance application for its J-Plasma/Renuvion device seeking a dermal resurfacing indication.
The Clearwater, Fla.-based company submitted a new 510(k) clearance application seeking new indications for the Renuvion system in December.
The application came supported by by data from a 55-patient, multi-center, single arm, evaluator-blind prospective investigational device exemption study of the system exploring its ability to reduce facial wrinkles and rhytides, Apyx Medical said.
The study, howev...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Regulatory/Compliance apyxmedical Source Type: news
