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 regulations, “or ...
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 because they inclu...
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 requires an IVD...
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 esophageal cancer. T...
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
UPDATE: FDA allows emergency use of Hologic’s Aptima, Procleix test for the Zika virus
Hologic (NSDQ:HOLX) said it won an emergency use exemption from the FDA for its Aptima diagnostic to detect Zika virus and for it and Grifols (NSDQ:GRFS) Procleix Zika screening assay under the FDA’s Investigational New Drug protocol.
The approval covers the detection of the Zika virus in human serum and plasma specimens and makes the test available immediately in the U.S., Puerto Rico and U.S. territories, Marlborough, Mass.-based Hologic said.
Zika, which the World Health Organization declared a global emergency in February, has been linked to microcephaly, a birth defect characterized by an unusually small h...
Source: Mass Device - June 20, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Diagnostics Wall Street Beat Hologic Inc. Zika virus Source Type: news
FDA looks to speed compassionate use applications
The FDA is finalizing steps to streamline the process used by physicians to request “compassionate use” access to investigational drugs and devices for their patients, according to FDA Commissioner Dr. Robert Califf.
Expanded access, often referred to as “compassionate use,” allows physicians to use investigational devices or drugs outside of a clinical trial to treat a patient suffering from a serious disease or condition with no alternative treatment option, according to the FDA.
“Access to investigational treatments requires the active cooperation of the FDA, industry, and health care pro...
Source: Mass Device - June 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Chapel Hill biotech gets FDA green light to test heart disease therapy
A Chapel Hill biotech heard good news from the U.S. Food and Drug Administration on Friday.
The regulatory body accepted an investigational new drug (IND) application from NanoCor Therapeutics, Inc. relating to Carfostin, an experimental cardiac gene therapy in development for the treatment of congestive heart failure (CHF).
Simply accepting the application is still a long way from approving a finished drug, of course, but is seen as an important milestone for drug developers. Now, NanoCor may… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 22, 2016 Category: Biotechnology Authors: Jason deBruyn Source Type: news
Chapel Hill biotech gets FDA green light to test heart disease therapy
A Chapel Hill biotech heard good news from the U.S. Food and Drug Administration on Friday.
The regulatory body accepted an investigational new drug (IND) application from NanoCor Therapeutics, Inc. relating to Carfostin, an experimental cardiac gene therapy in development for the treatment of congestive heart failure (CHF).
Simply accepting the application is still a long way from approving a finished drug, of course, but is seen as an important milestone for drug developers. Now, NanoCor may… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 22, 2016 Category: Pharmaceuticals Authors: Jason deBruyn Source Type: news
