Log in to search using one of your social media accounts:

 

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. Get this in your inbox everyday by subscribing to our newsletters.   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 Mas...
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. ...
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 ...
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

FDA clears IND for Cerveau ’ s tau imaging agent
Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like Alzheimer’s disease. Get the full story at our sister site, Drug Delivery Business News. The post FDA clears IND for Cerveau’s tau imaging agent appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diagnostics Food & Drug Administration (FDA) Neurological Regulatory/Compliance Cerveau Technologies Source Type: news

AntriaBio seeks FDA nod for trial of once-weekly insulin
AntriaBio (OTC:ANTB) said today that it filed an investigational new drug application with the FDA for its once-weekly basal insulin. If the Louisville, Colo.-based company wins approval from the FDA, it plans to launch a Phase I clinical trial of AB101 in patients with Type I diabetes. Get the full story at our sister site, Drug Delivery Business News. The post AntriaBio seeks FDA nod for trial of once-weekly insulin appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat antriabio Source Type: news

Sylentis initiates a Phase III study for the treatment of dry eye syndrome
(Pharmamar) The pharmaceutical Company Sylentis (PharmaMar Group) has announced the start of the first Phase III study, HELIX, with the investigational new drug, SYL1001 for the indication of dry eye syndrome. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 30, 2017 Category: International Medicine & Public Health Source Type: news

BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy
BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. Get the full story at our sister site, Drug Delivery Business News. The post BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat BioCorRx Source Type: news

Symic Bio raises $30m for peripheral vein graft failure therapy
Symic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures. Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, SB-061. The San Francisco-based company also said yesterday that it plans to launch a Phase III trial of SB-030 in 2018, following a pre-investigational new drug meeting with the FDA. Supported by interim results from the Phase I/IIa Shield study, the regulatory watchdog re...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Funding Roundup Surgical Vascular symicbio Source Type: news

ViaCyte to study PEC-Direct in international clinical trial for type 1 diabetes
US-based regenerative medicine firm ViaCyte has obtained approval for its investigational new drug (IND) application from both the US Food and Drug Administration and Health Canada to initiate a clinical trial for investigating PEC-Direct in patients … (Source: Drug Development Technology)
Source: Drug Development Technology - May 22, 2017 Category: Pharmaceuticals Source Type: news

Glenmark anti-myeloma drug gets clinical trial nod from USFDA
This is Glenmark's second investigational new drug from its immuno-oncology portfolio to enter clinical trials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 16, 2017 Category: Pharmaceuticals Source Type: news

Glenmark Pharmaceuticals to investigate GBR 1342 in Phase I trial for multiple myeloma
Indian pharmaceutical firm Glenmark Pharmaceuticals has obtained clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to commence a Phase I clinical trial of GBR 1342 to treat patients with multi … (Source: Drug Development Technology)
Source: Drug Development Technology - May 15, 2017 Category: Pharmaceuticals Source Type: news

First spherical nucleic acid drug injected into humans targets brain cancer
(Northwestern University) The first drug using spherical nucleic acids to be systemically given to humans has been developed by Northwestern University scientists and approved by the Food and Drug Administration as an investigational new drug for an early-stage clinical trial in the deadly brain cancer glioblastoma multiforme. The drug, which targets and down regulates genes that lead to disease, represents a revolutionary new class of drugs and has potential for other brain diseases. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - May 11, 2017 Category: Cancer & Oncology Source Type: news

FDA and NIH release final template for clinical trial protocols
By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final version of the template, a development which is likely to contribute important efficiencies to the process of protocol development, saving medical product development time and money. The final version is intended for clinical investigators who are writing protocols for phase 2 an...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

Vanda Pharmaceuticals expands into cystic fibrosis, blood cancer
D.C.-based Vanda Pharmaceuticals Inc. has expanded its portfolio to include research and development into treatments for cystic fibrosis and blood cancer. During a first-quarter earnings call this week, CEO Mihael Polymeropoulos said Vanda (NASDAQ: VNDA) is on track to file an investigational new drug application to the Food and Drug Administration in mid-2017 to start a new clinical trial in patients with blood cancers. Meanwhile, in March, Vanda agreed to pay up to $46 million to the University… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 4, 2017 Category: American Health Authors: Tina Reed Source Type: news

Genkyotex to initiate Phase II trial of GKT831 to treat PBC
The US Food and Drug Administration (FDA) has accepted French biopharmaceutical firm Genkyotex's investigational new drug (IND) application, allowing the company to initiate a Phase II trial of its GKT831 for the treatment of primary biliary cholangi … (Source: Drug Development Technology)
Source: Drug Development Technology - May 3, 2017 Category: Pharmaceuticals Source Type: news

Clinical Investigator Status (Biologics)
Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER (Source: What's New at CBER)
Source: What's New at CBER - April 20, 2017 Category: Biomedical Science Source Type: news

Sentien launches trial for drug-device combo for treating acute kidney injury
Sentien Biotechnologies said this week it received an Investigational New Drug approval for its SBI-101 drug-device combination product meant for treating individuals with acute kidney injury. The multi-center, Phase 1/2 trial will be the the 1st for the company, and will examine its platform which uses a blood filtering device containing mesenchymal stromal cells, often found in bone marrow, for the controlled, sustained delivery of MSC secreted factors. Read the whole story on our sister site, Drug Delivery Business The post Sentien launches trial for drug-device combo for treating acute kidney injury appeared first on M...
Source: Mass Device - April 19, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Drug-Device Combinations Sentien Biotechnologies Source Type: news

This is not a test: RMAT designation goes live
By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds for subsequent use. These products hold great promise in addressing serious unmet medical needs. For example, data from a number of different published studies indicate the potential for CAR-T cells to treat certa...
Source: Mass Device - March 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog FDA Source Type: news

Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 23, 2017 Category: Drugs & Pharmacology Source Type: news

FDA grants IND clearance for Servier ’s UCART19 to treat relapsed / refractory ALL
The US Food and Drug Administration (FDA) has granted an investigational new drug (IND) clearance to Servier to proceed with the clinical development of UCART19 in the country. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 13, 2017 Category: Pharmaceuticals Source Type: news

Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide. The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm. Get the full story at our sister site, Drug Delivery Business News. The post Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Respiratory Wall Street Beat Glenmark Pharmaceuticals Source Type: news

Celyad obtains FDA approval to initiate the NKR-2 CAR T cells THINK trial in the USA
IND (Investigational New Drug) approval triggers the initiation of the THINK trial in the U.S. Rosewell Park (NY) and University of Pittsburgh Medical Center – UPMC (PA) approved and ready to enroll patients. No toxic event in the other patients enro... Biopharmaceuticals, Oncology, FDA Celyad, NKR-T (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 8, 2017 Category: Pharmaceuticals Source Type: news

FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog. After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant. Titan also needs to identify a principal investigator for the study, although the company said it is in the process of qualifying the participating clinical sites. Get the full story at our sister site, Drug Del...
Source: Mass Device - February 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Implants Neurological Wall Street Beat Titan Pharmaceuticals Source Type: news

Renova takes over rights to heart failure candidate stresscopin from Janssen
US-based Renova Therapeutics has signed an agreement to receive the investigational new drug (IND) file for stresscopin from Janssen Pharmaceuticals. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 8, 2017 Category: Pharmaceuticals Source Type: news

Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to evaluate the safety, immunogenicity and preliminary efficacy of 2 dose levels of AU-011 for the treatment of small-to-medium primary ocular melanoma, according to Aura. Get the full story at our sister site, ...
Source: Mass Device - February 6, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Oncology Optical/Ophthalmic Regulatory/Clearance Wall Street Beat Aura Biosciences Source Type: news

Realm Therapeutics submits IND for PR022 to FDA for atopic dermatitis
US-based biopharmaceutical company Realm Therapeutics has submitted its first investigational new drug (IND) application for PR022 to the US Food and Drug Administration (FDA) for the treatment of patients affected with atopic dermatitis (AD). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - January 31, 2017 Category: Pharmaceuticals Source Type: news

NantKwest launches clinical trial for natural killer cells
NantKwest Inc. (NSDQ:NK) said yesterday that the FDA approved an Investigational New Drug Application for its natural killer cell therapy phase I clinical study. The company is evaluating its genetically engineered, allogenic natural killer cell therapy in patients with cancer. The study, which NantKwest touts as the 1st of its kind, will determine the safety of natural killer cell monotherapy given intravenously once a week in as many as 16 patients with metastatic or locally advanced solid tumors. Get the full story at our sister site, Drug Delivery Business News. The post NantKwest launches clinical trial for natur...
Source: Mass Device - January 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Oncology Wall Street Beat NantKwest Source Type: news

Deals this week: Takeda Pharmaceutical, HUYA Bioscience International, Egalet
Japanese pharmaceutical company Takeda Pharmaceutical has signed a global agreement with US-based bio-pharmaceutical company Ovid Therapeutics for clinical development and commercialisation of the former ’s investigational new drug TAK-935. (Source: Drug Development Technology)
Source: Drug Development Technology - January 20, 2017 Category: Pharmaceuticals Source Type: news

Keystone Nano wins FDA nod for nanoliposome cancer treatment
Keystone Nano said today that the FDA approved its investigational new drug application for the ceramide nanoliposome as a treatment for solid tumors. The company will launch a phase I trial at 3 sites to evaluate safe dosing levels and the product’s efficacy as a cancer therapy. Ceramide is a lipid that has demonstrated efficacy in liver cancer, breast cancer, leukemia and pancreatic cancer. Preclinical evidence has shown that Keystone’s nanoliposome is an effective delivery system for the bioactive compound, targeting cancer cells and ignoring healthy cells. Get the full story at our sister site, Dr...
Source: Mass Device - January 5, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Oncology Pharmaceuticals Regulatory/Clearance Wall Street Beat Keystone Nano Source Type: news

Glenmark receives IND application clearance to begin Phase I trial of GBR 1302-BEAT for HER2+ cancer
The US Food and Drug Administration (FDA) has cleared pharmaceutical company Glenmark ’s investigational new drug (IND) application to begin a phase I trial of GBR 1302-BEAT to treat HER2+ cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Investigational new drug for Alzheimer's scheduled for first study in humans
(Vanderbilt University Medical Center) Vanderbilt University scientists have received notification from the US Food and Drug Administration (FDA) that testing in humans may proceed for an investigational new drug for Alzheimer's disease after more than 10 years of research by scientists at Vanderbilt University and Vanderbilt University Medical Center. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 27, 2016 Category: Global & Universal Source Type: news

Organovo unveils bioprinted liver transplant patches
Organovo (PINK:ONVO) today announced it is developing 3D bioprinted human liver tissue designed for direct transplantation to patients. The move to human development comes based on “strong results” from preclinical animal model studies, the San Diego, Calif.-based company said. The company expects to pursue a formal preclinical development program. “We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising. The scientific and commercial progress we have already m...
Source: Mass Device - October 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Regenerative Medicine Organovo Source Type: news

Ablative Solutions wins FDA nod for Phase II chemical denervation trial
Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application. The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control hypertension. Ablative Solutions said the 100-patient, randomized, double-blind, sham-controlled trial is slated to enroll patients at 20 global sites. The Peregrine system is minimally invasive, using a small access site in the femoral artery to snake...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Ablative Solutions Hypertension Medtronic St. Jude Source Type: news

​Moderna to seek permission to test Zika vaccine in humans this year
Cambridge-based Moderna Therapeutics is joining a select few biotechs around the world in the hunt for a vaccine for the Zika virus, thanks to an $8 million award from the federal government. The company says it plans to file an investigational new drug application with the U.S. Food& Drug Administration by the end of 2016, which will allow it to begin Phase 1 trials on the vaccine. It ’s the first time the company has disclosed that it is working on a drug to prevent the mosquito-borne infection… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 7, 2016 Category: Pharmaceuticals Authors: Don Seiffert Source Type: news

Xenetic receives FDA approval to initiate Phase II trial of Virexxa to treat endometrial cancer
Biopharmaceutical company Xenetic has received the US Food and Drug Administration (FDA) approval of an investigational new drug (IND) application to begin the Phase II clinical trial of Virexxa for the treatment of endometrial cancer in women. (Source: Drug Development Technology)
Source: Drug Development Technology - August 21, 2016 Category: Pharmaceuticals Source Type: news

Moberg obtains approvals to initiate Phase III trial of MOB-015 to treat onychomycosis
Swedish-based pharmaceutical company Moberg Pharma has obtained the US Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application, as well as a no-objection letter from Health Canada to start its Phase III trial of … (Source: Drug Development Technology)
Source: Drug Development Technology - August 10, 2016 Category: Pharmaceuticals Source Type: news

Title 21: 1981
When you visit IMARC Research’s office, you will notice beautiful artwork on our lobby wall.  The artwork pays homage to key events in the history of clinical research.  We also released an eBook that describes all the images that make up the timeline and we encourage everyone to take advantage of this important information. In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations. The terms, “according to the regu...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog IMARC Source Type: news

VM BioPharma receives South Korea MFDS approval for Phase II trial of VM202 to treat IHD
South Korean-based ViroMed ’s US biopharmaceutical division VM BioPharma has secured Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety in Korea (MFDS) to conduct the Phase II clinical trial of VM202 for ischemic heart d… (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2016 Category: Pharmaceuticals Source Type: news

T3D Therapeutics Announces Presentation of Phase 2a Preliminary...
An investigational new drug, T3D-959, elicited rapid improvement in ADAS-cog11 cognitive tests in 53% of subjects with mild to moderate Alzheimer’s disease in an exploratory, open label Phase 2a...(PRWeb August 03, 2016)Read the full story at http://www.prweb.com/releases/2016/08/prweb13590398.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - August 3, 2016 Category: Pharmaceuticals Source Type: news

Piloting an improved intercenter consult process
By: Michael Rappel, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Over the last few months, we’ve shared what FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review process. We are pleased to update you on the proposed intercenter consult request (ICCR) process that will be piloted across the Agency today. Combination products—those that combine drugs, devices, and/or biological products—present both policy and review challenges in large part becaus...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog FDA Source Type: news

US regulators recommend “codevelopment” approach for IVD companion Dx products
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration is recommending steps for both manufacturers and its own staff regarding contemporaneous market authorization for therapeutic products and IVD companion diagnostics. In new draft guidance, the agency notes that “codevelopment” of therapeutic products along with IVD companion diagnostics is necessary to “facilitate innovation in precision medicine;” codevelopment as the FDA defines the term encompasses principles for product development, market authorization as well as clinical trial planning. Typically, a therapeutic product that...
Source: Mass Device - July 28, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Emergo Group Source Type: news

CANbridge receives IND approval from TFDA for Phase I/II trial of CAN-008 to treat GBM
China-based biopharmaceutical company CANbridge Life Sciences has secured approval for the investigational new drug (IND) application from the Taiwan Food and Drug Administration (TFDA) to conduct the Phase I/II clinical trial of CAN-008 for patients … (Source: Drug Development Technology)
Source: Drug Development Technology - July 27, 2016 Category: Pharmaceuticals Source Type: news

Biostage files for orphan drug designation for Cellspan artificial esophagus
Organ regeneration specialist Biostage (NSDQ:BSTG) said it asked the FDA for orphan drug status for its Cellspan artificial esophagus. If the request is granted, Holliston, Mass.-based Biostage, formerly know as Harvard Apparatus Regenerative Technology, would win 7 years of market exclusivity after FDA approval, plus tax credits and an exemption from the federal safety watchdog’s drug registration fees. “This submission is the 1st step in our effort to secure orphan status for our Cellspan esophageal implant, which we believe has the potential to be a valuable option in the treatment of esophage...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Biostage Inc Source Type: news

Sangamo BioSciences Announces FDA Clearance of Investigational New Drug Application for ZFN-Mediated Genome Editing Treatment of MPS II
Company Advances Third In Vivo Protein Replacement Platform™ (IVPRP) Program into Clinical Development RICHMOND, Calif., June 20, 2016 -- (Healthcare Sales & Marketing Network) -- Sangamo BioSciences, Inc. (SGMO), the leader in therapeutic genome editi... Biopharmaceuticals, FDASangamo BioSciences, Hunter syndrome (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 20, 2016 Category: Pharmaceuticals Source Type: news