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FDA Clears Affected person Controller Platform for Stimwave’s Neuromodulation Machine

Posted in News on 5th November 2018
WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy

WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy

The Food and Drug Administration has cleared the WaveCrest Mobile iOS Platform for patients with Stimwave’s Wireless Freedom Spinal Cord Stimulator (SCS) System, allowing them to control their pain relief therapy through an iPhone or Apple Watch. 

The Stimwave SCS System utilizes a tiny injectable microchip device that sends small pulses of energy to electrodes near surrounding nerves. This elicits a reaction that allows the remapping of specific pain signals, thus resulting in pain relief. The device is implanted under the skin in an outpatient procedure. “The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Dr. Ellen Lin, MD, medical director of San Antonio’s Advanced Spine and Pain Center.

The new software enables patients to fine-tune the power level and modify programs that were pre-programmed by their clinician to control pain. 

Part 2 STEMTRA trial utilizing SB623 cells for treating traumatic mind harm meets major endpoint

Posted in News on 4th November 2018

The SanBio Group (SanBio Co., Ltd. and subsidiary SanBio Inc.; collectively, the “Firm”) proclaims as we speak that the Part 2 STEMTRA trial utilizing SB623 cells for the remedy of sufferers with traumatic mind harm (TBI), met its major endpoint.

This STEMTRA research confirmed that TBI sufferers with continual motor deficits handled with SB623 cells demonstrated a statistically vital enchancment of their motor operate in comparison with the management group, primarily based on the Fugl-Meyer Motor Scale (FMMS). The research met its major endpoint, with SB623 sufferers attaining a median eight.7 level enchancment from baseline within the FMMS, versus 2.four within the management group, at 24 weeks. The protection information confirmed that SB623 was nicely tolerated and no new security alerts had been recognized.

“This international medical trial, the most important stem cell research ever performed for TBI, is particularly thrilling given the rigor of its randomized double-blind design and demonstration of serious enchancment in motor operate for a lot of sufferers handled with SB623 cells,” stated Damien Bates MD, PhD, Chief Medical Officer and Head of Analysis at SanBio Group. “It is a vital milestone for regenerative medication and for a lot of sufferers affected by persistent disabilities brought on by TBI.” Primarily based on this research, SanBio Group goals to file for advertising and marketing approval in Japan within the fiscal 12 months ending January 2020.

The result of this research is prone to have minimal influence on the earnings of SanBio Group for the present fiscal 12 months. Nonetheless, SanBio Group believes that it’s going to enhance the Firm’s earnings within the medium to long run.

Supply:

http://san-bio.com/

FDA: Class I Recall of Check Strips Because of Inaccurate INR Outcomes

Posted in News on 4th November 2018

November 02, 2018

The Agency has received approximately 90 medical device reports

The Agency has received approximately 90 medical device reports

Roche Diagnostics has issued a recall of certain lots of CoaguChek XS PT Test Strips, as these test strips may provide inaccurate results when used with CoaguChek test meter devices to monitor levels of warfarin. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall, meaning that use of the device may cause serious injuries or death.

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled. The full list of lot numbers can be found here.

“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

Medical device reports submitted by Roche Diagnostics to the FDA indicate that the test strips may provide higher than actual INR (International Normalized Ratio) results which could potentially lead to inaccurate warfarin dosing. The Agency has received approximately 90 medical device reports; 2 serious patient injuries involving strokes have been reported.

Roche Diagnostics stated in a press release that the problem was caused by “a recent re-calibration of the test strips to a different international standard that occurred earlier this year.” The Company will be providing new batches of re-calibrated test strips, based on the previous international standard, by the end of November; these test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.

The FDA is urging healthcare providers to report all INR test meter problems to MedWatch. At this time, clinicians who have been using the recalled test strips should not rely on the CoaguChek meter results to determine whether warfarin dosing is appropriate.

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For more information visit FDA.gov.

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Section 2 examine of ziresovir for treating hospitalized RSV contaminated infants achieves important progress

Posted in News on 3rd November 2018

Ark Biosciences, a biotech firm creating proprietary therapeutics for viral an infection and respiratory ailments, introduced in the present day the numerous progress in its part 2 proof-of-concept examine of ziresovir within the remedy of hospitalized RSV contaminated infants. The unblinded medical efficacy outcomes of half 1 of the part 2 examine will probably be introduced on the 11th Worldwide RSV Symposium to be held in Asheville, North Carolina and additional particulars on progress on the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics – to be held in Washington DC, USA in November.

The anti-RSV drug ziresovir, a novel RSV F-protein inhibitor, was found by Roche scientists, and was licensed to Ark Biosciences in 2014. Ark Biosciences has accomplished a number of medical research with the compound, together with two part 1 medical research in wholesome grownup volunteers in Australia and China, a part 1 human mass steadiness examine in the UK. Ark has additionally been conducting a worldwide part 2 PoC medical trial of ziresovir entitled VICTOR (Viral Inhibition in Youngsters for Remedy of RSV). The examine is “A Randomised, Double-blind, Placebo-controlled, 2-Half Examine of Orally Administered AK0529 to Consider the Security, Tolerability, Pharmacokinetics and Antiviral Impact of Single and A number of Dosing in Hospitalized Infants with Respiratory Syncytial Virus An infection”. Within the examine ziresovir is being investigated for its security and medical efficacy in infants hospitalized for decrease respiratory tract an infection with naturally acquired RSV an infection.

“Now we have made an ideal progress within the medical improvement of ziresovir as first-line antiviral remedy for the remedy of RSV contaminated sufferers, particularly hospitalized infants, which is the place the best unmet medical want exists,” stated Dr Jim Z. Wu, founder and CEO of Ark Biosciences. “We stay up for sharing the promising security and medical efficacy information from our part 2 VICTOR examine with the medical neighborhood on the upcoming worldwide conferences.”

Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, commented that, “There is a gigantic want for brand new medicines to deal with the hundreds of thousands of pediatric and aged sufferers that suffer RSV an infection yearly. Within the accomplished first a part of the part 2 VICTOR examine for the remedy of infants hospitalized with RSV an infection, for the primary time ever, an antiviral agent, ziresovir, has demonstrated glorious security profile and a transparent dose-dependent medical efficacy, decreasing sufferers’ indicators and symptom scores. We stay up for reporting these thrilling medical leads to the upcoming 11th Worldwide RSV Symposium in Asheville and the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics in Washington DC.”

With the event of ziresovir, Ark goals to be the trade chief in anti-RSV drug improvement, and to develop the first-in-disease anti-RSV drug to fulfill the extraordinarily massive unmet medical want posed by RSV an infection.

Supply:

http://www.arkbiosciences.com/

Dsuvia Accepted for Administration of Acute Ache in Healthcare Settings

Posted in News on 3rd November 2018

November 02, 2018

Dsuvia will not be available in retail pharmacies or for outpatient use

Dsuvia will not be available in retail pharmacies or for outpatient use

AcelRx announced that the Food and Drug Administration (FDA) has approved Dsuvia (sufentanil) sublingual tablets for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours.

The sublingual formulation of sufentanil offers a new treatment option for patients with nothing by mouth (NPO) status and patients with difficult IV access (eg, obese, burn, elderly, needle-phobic patients) to manage acute pain. The single-unit packaging and single-strength sublingual tablets are intended to mitigate the possibility of dosing errors, misuse, and diversion. “Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research.

Dsuvia was evaluated in a randomized, double-blind, placebo-controlled study (N=161) involving patients with acute postoperative pain after abdominal surgery (studied up to 48hrs). Study patients were randomized to Dsuvia 30mcg or placebo as needed with dosing at least 60mins apart; IV morphine sulfate was available as rescue medication. 

The data showed a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared with placebo. The difference in pain intensity from baseline was superior to that of the placebo group within 15 minutes. Also, a smaller proportion of patients in the Dsuvia group took rescue medication within the first 12 hours of the treatment phase, as compared with the placebo group (22% vs 65%). Regarding safety, the most commonly reported adverse reactions were nausea, headache, vomiting, dizziness, and hypotension. 

In a statement, the FDA’s Commissioner Scott Gottlieb, MD, said, “The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise […] I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”

Dsuvia, a Schedule II substance, will be available as 30mcg strength sublingual tablets in a single-dose, pre-filled applicator for administration by a healthcare professional only in certified medically supervised settings. Distribution is expected in the first quarter of 2019 only to healthcare settings certified in the Dsuvia Risk Evaluation Mitigation Strategy (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use.

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For more information call (650) 216-3500 or visit AcelRx.com.

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