Triphase Accelerator to Present Investigational New Drug Enabling Data...
Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, and Catalent, the leading global provider of advanced delivery...(PRWeb December 04, 2017)Read the full story at http://www.prweb.com/releases/2017/12/prweb14977095.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - December 4, 2017 Category: Pharmaceuticals Source Type: news
Capricor Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for CAP-1002
Potential Registration Trial in Duchenne Muscular Dystrophy on Track to Initiate in First Quarter of 2018
Company to Host Conference Call and Webcast at 4:30 p.m. ET Today
LOS ANGELES, Nov. 29, 2017 -- (Healthcare Sales & Marketing Network) -- Capri... Biopharmaceuticals, FDA Capricor Therapeutics, Duchenne muscular dystrophy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 29, 2017 Category: Pharmaceuticals Source Type: news
Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today.
After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain.
Get the full story at our sister site, Drug Delivery Business News.
The post Cerveau inks licensing deal with AbbVie for tau imaging agent appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Imaging Pharmaceuticals Wall Street Beat AbbVie Cerveau Technologies Source Type: news
FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product.
The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both its guidance of between $70 and $80 million and Wall Street consensus of $80.1 million.
Revenue for MiMedx grew 31% compared to sales from the 3rd quarter of the previous year, according to an SEC filing.
“Our third quarter revenue performance was very strong, and we are v...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials MiMedx Group Inc. Source Type: news
America & #039;s Blood Supply Can Now Be Screened for Zika
America’s blood supply is better protected from the Zika virus, now that FDA has approved the first test designed to detect the virus in blood donations.
Learn about the IVD market at BIOMEDevice San Jose, Dec. 6-7, 2017.
The cobas Zika test from Roche has already been used by several U.S. blood collection establishments under an investigational new drug application (IND). The test can also screen for the virus RNA in specimens collected from living organ donors.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Peter Marks, MD, Ph...
Source: MDDI - October 10, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Regulatory and Compliance Source Type: news
Prometic to conduct PBI-4050 ’s Phase II/III trial for IPF in US
Canada-based Prometic Life Sciences has secured investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to evaluate its drug candidate PBI-4050 in a Phase II/III clinical trial to treat idiopathic pulmonary fibrosis (IP … (Source: Drug Development Technology)
Source: Drug Development Technology - September 25, 2017 Category: Pharmaceuticals Source Type: news
Realm Therapeutics to initiate Phase II trial for allergic conjunctivitis
Realm Therapeutics is set to initiate a Phase II clinical trial of PR013 to treat allergic conjunctivitis (AC), following approval of its investigational new drug (IND) application by the US Food and Drug Administration (FDA). (Source: Drug Development Technology)
Source: Drug Development Technology - September 11, 2017 Category: Pharmaceuticals Source Type: news
MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles Tendonitis
MARIETTA, Ga., Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts ... Biopharmaceuticals, Regenerative Medicine, Orthopaedic, FDA MiMedx Group, AmnioFix, achilles tendonitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 7, 2017 Category: Pharmaceuticals Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Soft, water-powered robot makes endoscopic surgery easier
Harvard researchers have created a rigid-soft robotic arm for endoscopes that can sense, flex and has multiple degrees of freedom.
Flexible endoscopes fit through narrow...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Titan wins FDA nod to study Parkinson ’ s implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA cleared the investigational new drug application for its ropinirole implant designed to treat the symptoms of Parkinson’s disease.
The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, according to the South San Francisco, Calif.-based company.
Get the full story at our sister site, Drug Delivery Business News.
The post Titan wins FDA nod to study Parkinson’s implant appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Implants Neurological Pharmaceuticals Wall Street Beat Titan Pharmaceuticals Source Type: news
MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January.
The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company.
“The transaction is expected to be completed in the 3rd quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. of all claims and rights to...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine MiMedx Group Inc. Stability Biologics Source Type: news
Update: Temporary Total Depletion of U.S. Licensed Yellow Fever Vaccine for Civilian Travelers Addressed by Investigational New Drug Use of Imported Stamaril Vaccine
(Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - July 27, 2017 Category: American Health Source Type: news
Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that the FDA granted orphan drug status to its long-acting cosyntropin acetate formulation, MNK-1411, for the treatment of Duchenne muscular dystrophy.
In August last year, the FDA approved the company’s request to fast track its investigational new drug application for the therapy.
Get the full story at our sister site, Drug Delivery Business News.
The post Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat Mallinckrodt Source Type: news
How FDA plans to help consumers capitalize on advances in science
By: Scott Gottlieb, M.D.
We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being translated into new medicines. In more cases, these treatments target the underlying mechanisms that drive different diseases. These advances hold out the promise of arresting and even curing a growing number of diseases.
To build upon such opportunities, FDA will soon unveil a co...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news
Shire submits IND application for SHP654 to treat haemophilia A
Irish-based Shire has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for SHP654, also designated as BAX 888, an investigational factor VIII (FVIII) gene therapy to treat haemophilia A. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 9, 2017 Category: Pharmaceuticals Source Type: news
