PALM BEACH, Florida, May 3, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
Themulti-billion dollar Biotech Industry is witnessing a transformation as it relates to the advancement of transdermal drug delivery patches. On the back of factors like rising number of transdermal drug delivery products, enhanced awareness in developed
Aequus Pharmaceuticals Inc. (TSX-V: AQS.V) (OTCQB: AQSZF) BREAKING NEWS: Aequus Pharmaceuticals, a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received positive feedback from the US Food and Drug Administration ("FDA") on its pre-Investigational New Drug ("pre-IND") submission for the Company's long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application ("NDA") for the program in the United States. "We are very encouraged with the responses from the FDA on our anti-nausea program," said Doug Janzen, Chairman and CEO of Aequus. "The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success." "Camargo's goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners," said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. "We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide." In support of the Company's planned clinical strategy, the FDA indicated that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period. Read this and more news for Aequus Pharmaceuticals at http://www.marketnewsupdates.com/news/aqs.html
In other biotech/pharma developments from around the markets: InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) closed Wednesday up over 70% at $13.49 with over 3 million shares traded by the market close. InVivo Therapeutics is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children's Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™.
InspireMD Inc. (NYSE: NSPR) came to a closed up over 4% at $1.25 on Wednesday with over 3 million shares traded on the day and was also up in afterhours trading of more than 6%. InspireMD recently announced it has received regulatory approval, and has initiated commercialization of its CGuard™ Embolic Prevention System (EPS) and MGuard Prime™ in Vietnam. Both of these devices utilize the company's patented MicroNet™ technology. "Our ability to initiate commercialization for both of the company's devices was due to our capability to coordinate getting three key elements in place concurrently and quickly. Specifically, we secured regulatory approval, a valid import license and product reimbursement, all of which come from Vietnam's Department of Medical Equipment and Health Works (DMEHW), a unit of the Ministry of Health (MOH). Part of this effort was coordinated by DO GIA, our recently appointed distributor in Vietnam.
Baxter International Inc. (NYSE: BAX) recently announced a partnership with the International Society of Nephrology (ISN) to advance chronic kidney disease (CKD) awareness and help improve access to therapy, particularly in low- and middle-income countries (LMIC) - commonly referenced as emerging markets - where the disease prevalence is growing the fastest. The collaboration will support greater disease and therapy research and education, as well as work to help establish better care models that support high standards of care at a lower cost in LMIC. "ISN and Baxter's collaboration aims to address the urgent and growing challenge kidney disease is causing healthcare systems in providing quality care to patients globally," said David Harris, M.D., ISN President, University of Sydney, Australia.
Medtronic Plc. (NYSE: MDT) on Wednesday announced the advanced SynergyTLIFSM workflow - a procedural solution for spine surgery that combines innovative technologies to create a completely navigated minimally invasive procedure that allows fewer intra-operative surgical steps. The announcement was made during the American Association of Neurological Surgeons (AANS) annual meeting in New Orleans, La. The advanced SynergyTLIF Workflow combines the O-arm(TM) System imaging and StealthStation(TM) imaging guidance for navigated: Minimally invasive access; Screw preparation via navigated Stealth-Midas(TM) Drilling System; Interbody disc preparation instruments; Interbody placement of the Elevate(TM) Spinal System expandable interbody device; Screw placement of the CD Horizon(TM) Solera(TM) Voyager(TM) 4.75 and 5.5 ATS(TM) Screws. "The advanced SynergyTLIF workflow allows me to see every step of the patient`s minimally invasive procedure through real-time 3D imaging," said Dr. Jean-Pierre Mobasser, neurosurgeon at Goodman Campbell Brain & Spine/Indiana University, Department of Neurosurgery in Indianapolis, Ind.
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