The Investigational New Drug (IND) Submission - Tips to Win the First Time
Date: Thursday, January 21, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts and Job Aids! (Source: Medical Design Online News)
Source: Medical Design Online News - December 8, 2015 Category: Medical Equipment Source Type: news

The Investigational New Drug (IND) Submission - Tips to Win the First Time
Date: Thursday, January 21, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts and Job Aids! (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - December 8, 2015 Category: Pharmaceuticals Source Type: news

Exploring a New Mechanism of Action for MS DrugsExploring a New Mechanism of Action for MS Drugs
An investigational new drug for multiple sclerosis has an entirely new mechanism of action. Medscape Neurology (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - December 2, 2015 Category: Neurology Tags: Neurology & Neurosurgery Expert Interview Source Type: news

Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-FIX, First In Vivo Protein Replacement Platform Program For Treatment Of Hemophilia B
Study, Scheduled to Begin in 2016, Will Represent First Clinical Application of In Vivo Genome Editing RICHMOND, Calif., Dec. 1, 2015 -- (Healthcare Sales & Marketing Network) -- Sangamo BioSciences, Inc. (SGMO), the leader in therapeutic genome editin... Biopharmaceuticals, FDASangamo BioSciences, SB-FIX, hemophilia B, genome editing, IVPRP (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 1, 2015 Category: Pharmaceuticals Source Type: news

Glaukos submits IND for Travoprost eluting iDose
Glaukos (NYSE:GKOS) said it submitted an Investigational New Drug application to the FDA for its Travoprost intraocular implant delivered with the company’s iDose delivery system to reduce elevated intraocular pressure in patients with glaucoma. The Travoprost intraocular implant is injected through a clear corneal incision and secured in the anterior chamber, where the iDose system provides continuously elutes therapeutic levels of medication for an extended period of time, Glaukos said. “This IND submission represents a seminal milestone, which the Glaukos team achieved well ahead of our original 2016 time...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Glaukos Corp. Source Type: news

FDA accepts Immune's IND for bertilimumab to treat bullous pemphigoid
The US Food and Drug Administration (FDA) has accepted Immune Pharmaceuticals' investigational new drug (IND) application for its first in class, lead product candidate, bertilimumab, to treat Bullous Pemphigoid (BP). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - November 11, 2015 Category: Pharmaceuticals Source Type: news

Immune Pharmaceuticals Announces FDA Acceptance Of Investigational New Drug (IND) Application In The U.S. For Bertilimumab For The Treatment Of Bullous Pemphigoid
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - November 10, 2015 Category: Pharmaceuticals Source Type: news

Female Sex Hormone May Save Injured Soldiers On The Battlefield
This story was originally published by The UAB Mix. Breakthrough research suggests a female sex hormone may be the key to saving lives on the battlefield, where between 2001 and 2011 more than 80 percent of potentially preventable U.S. war injury deaths resulted from blood loss. The hormone shows the promise of prolonged survival despite massive loss of blood and could be carried in a small autoinjector for use. In a landmark step – after 19 years of research by Irshad Chaudry, Ph.D. – UAB has received a $10 million U.S. Department of Defense contract funded by the Combat Casualty Care Research Program, U.S. Ar...
Source: Science - The Huffington Post - October 30, 2015 Category: Science Source Type: news

Female Sex Hormone May Save Injured Soldiers On The Battlefield
This story was originally published by The UAB Mix. Breakthrough research suggests a female sex hormone may be the key to saving lives on the battlefield, where between 2001 and 2011 more than 80 percent of potentially preventable U.S. war injury deaths resulted from blood loss. The hormone shows the promise of prolonged survival despite massive loss of blood and could be carried in a small autoinjector for use. In a landmark step – after 19 years of research by Irshad Chaudry, Ph.D. – UAB has received a $10 million U.S. Department of Defense contract funded by the Combat Casualty Care Research Program, U.S. Ar...
Source: Science - The Huffington Post - October 30, 2015 Category: Science Source Type: news

FDA accepts Tyme's IND application for oncology drug candidate
The US Food and Drug Administration (FDA) has accepted Tyme Technologies' investigational new drug (IND) application for its drug candidate, SM-88, for treatment of breast cancer. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 27, 2015 Category: Pharmaceuticals Source Type: news

Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
SAN DIEGO, Oct. 5, 2015 -- (Healthcare Sales & Marketing Network) -- Otonomy, Inc. (OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today a... Biopharmaceuticals, FDAOtonomy, OTO-311, tinnitus (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 5, 2015 Category: Pharmaceuticals Source Type: news

ESSA gets FDA all-clear to start clinical development of prostate cancer treatment
Canada-based ESSA Pharma has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a Phase I/II clinical trial of its new agent, EPI-506, to treat patients with metastatic castrat… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 24, 2015 Category: Pharmaceuticals Source Type: news

Corbus enrols first patient in Phase II trial of Resunab to treat cystic fibrosis in adults
US-based Corbus Pharmaceuticals Holdings has started patient enrolment in the Phase II clinical trial of its investigational new drug Resunab to treat adult patients with cystic fibrosis (CF). (Source: Drug Development Technology)
Source: Drug Development Technology - September 21, 2015 Category: Pharmaceuticals Source Type: news

pSividia eyes knee market, releases earnings
pSivida (NSDQ:PSDV) released its fiscal year earnings for 2015 yesterday and said it’s eyeing an entrance into the orthopedic knee market with a new drug-device implant. The company said it is slated to submit an investigational new drug application with the FDA and begin a study of a new implant using its Durasert technology to treat severe osteoarthritis pain in the knee. Psivida claims the new device would be surgically implanted in the knee and provide sustained delivery of a corticosteroid directly to the joint for approximately 6 months. “With over 10 million cases of knee osteoarthritis and 700,000 knee ...
Source: Mass Device - September 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Drug-Device Combinations Implants Surgical pSivida Corp. Source Type: news

Brain Tumors vs. California Stem Cell Program: Disease-a-Week Challenge #8
When Vice President Joe Biden stood beside the coffin of his son Beau, it seemed the whole world took a breath. Every parent knew what he must be feeling: one of the most powerful men on Earth, and yet he could not save his son. Beau Biden was diagnosed with a malignant brain cancer, possibly a glioma: the same malady which took the lives of Ted Kennedy, Gene Siskel, Susan Hayward, George Gershwin and too many others. Brain cancers like Beau Biden's kill about 15,000 adults each year. This is a deadly condition. Even with the best treatment available--surgery, radiation, chemotherapy--survival averages only about 15 mon...
Source: Science - The Huffington Post - July 17, 2015 Category: Science Source Type: news