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Why Regulations for Clinical Trials are Resulting in Streamlined Approval Process
PALM BEACH, Florida, March 14, 2019 /CNW/ -- Recent upgrades in international and domestic regulations regarding clinical trials, are both designed to protect patients, but also to upgrade the 'new normal' procedures in clinical trial quality and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. Internationally, the key regulation is Good Clinical Practice, which is: "Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions." Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), ViewRay, Inc. (NASDAQ: VRAY), PAVmed Inc. (NASDAQ: PAVM), Corindus Vascular Robotics, Inc. (NYSE: CVRS), Teva Pharmaceutical Industries Limited (NYSE: TEVA).
A respected industry source added that they feel that "technology increases efficiency" and feels that if clinical trials are conducted using new compliant technology, that is also reduce cost of the trials and could also shorten the time to market. And by following these regulations, the FDA is also providing a faster pathway in the U.S.. A Forbes article discussed this new pathway: "In an ever-changing healthcare landscape, FDA seeks a new procedure that will let the market continue to develop but also offer a safe environment for the users. "The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," said FDA Commissioner Scott Gottlieb. The move comes shortly after the FDA announced plans to modernize the medical device 510(k) clearance pathway; The De Novo device classification requests should help market applicants better determine whether to utilize this registration pathway given its significant cost.
Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS: Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), highlights the Company's important partnership with Sanmina Corporation (Nasdaq: SANM) to advance its acoustic shockwave technology into the commercialization phase in preparation for product launch.
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Sanmina is a global contract electronics manufacturer and one of the world's largest medical device manufacturers. Under the agreement, Sanmina will provide the design and testing to advance Soliton's RAP device for use in future clinical trials and eventually to lay the foundation for a commercial launch of the Company's products.
"Working with Sanmina in this commercialization phase not only provides us with world-class quality and documentation," commented Dr. Chris Capelli, Soliton's CEO, "but we also believe it will make for a smoother transition to manufacturing, which we expect to begin here in the US later this year." Read this and more news for SOLY at: https://www.financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
ViewRay, Inc. (NASDAQ: VRAY) Last month the company announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market new soft tissue visualization capabilities for its MRIdian system.
The new upgradable capabilities enhance the industry-leading features of MRIdian's SmartVISION MRI, including:
- Expanded high-definition visualization and enhanced contrast between different tissues, to assist clinicians with tissue visualization and beam contouring
- The potential to aid in the assessment and prediction of tumor response to radiation therapy is enabled by "DWI", our diffusion weighted imaging feature which tracks treatment progress by distinguishing between tumor and normal tissues
- Faster, brighter, more detailed anatomical planar imaging to strike tumors with greater precision and accuracy through our proprietary technology, which allows for a 2X increase in MR imaging speed (to 8 frames per second), a 2X increase in image resolution, and a 2X improvement in MR signal-to-noise ratio (SNR)
- Potential reduction in treatment delivery time through enhanced MLC speed
PAVmed Inc. (NASDAQ: PAVM), a highly differentiated, multiproduct medical device company, announced that its PortIO™ Intraosseous Infusion System, which consists of an implantable intraosseous vascular access device and insertion kit, was able to achieve a maintenance-free implant duration of over 60 days in pre-clinical animal testing.
Former President of the Society of Interventional Radiology (SIR), Timothy P. Murphy, M.D., described this announcement as "a truly groundbreaking accomplishment in the field of vascular access which, if replicated in clinical practice, would represent one of the most important advances in long-term vascular access that I have seen during my career. All other vascular access devices, whether short, medium or long-term are limited by the need for regular maintenance with flushes which are labor intensive, costly and interfere with a patient's activity."
Corindus Vascular Robotics, Inc. (NYSE: CVRS), a leading developer of precision vascular robotics, announced the execution of an additional closing of the private placement previously announced on February 26, 2019. In the additional closing, existing investors with preemptive rights purchased an aggregate of 3,512,124 shares of the Company's common stock on the same terms and at the same price of $1.3796 per share as the initial closing through the exercise of such preemptive rights and the purchase of certain additional shares. The additional closing resulted in gross proceeds to the Company of approximately $4.8 million and, together with the initial closing, aggregate net proceeds of approximately $19.5 million. The Company intends to use the proceeds for general corporate purposes.
Participating investors included significant existing stockholders, Hudson Executive Capital and BioStar Ventures, a strategic venture capital partnership, including key interventional physicians focused on accelerating value creation for transformational medical device technologies.
Teva Pharmaceutical Industries Limited (NYSE: TEVA) this month announced the launch of an authorized generic of Flector®1 Patch, 1.3 %, in the U.S.
Diclofenac Epolamine Topical Patch, 1.3%, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the topical treatment of acute pain due to minor strains, sprains and contusions.
"The launch of our authorized generic of Flector® Patch in the U.S. is an important addition to Teva's portfolio of over 40 generic pain management medicines," said Brendan O'Grady, EVP and Head of North America Commercial.
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