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
Roswell Park exploring more Cuban vaccines
Just six weeks after announcing a lung cancer vaccine development deal with a Cuban cancer research center, officials from Roswell Park Cancer Institute are looking at several more vaccine opportunities in the country.
While it works to complete an investigational new drug (IND) application with the U.S. Food & Drug Administration, a group from Roswell Park will travel to Cuba in July to explore additional opportunities.
“There’s lots of enthusiasm,” said Candace Johnson, CEO. “We’re… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 1, 2015 Category: Pharmaceuticals Authors: Tracey Drury Source Type: news
UCLA scientists explain mechanism that makes their mouthwash so effective against tooth decay
In 2011, UCLA’s Dr. Wenyuan Shi developed a mouthwash that could eliminate the bacteria that is the principal cause of tooth decay.
A new study led by Shi, chair of the section of oral biology at the UCLA School of Dentistry, describes more precisely the mechanism that makes the mouthwash’s active ingredient so effective.
The research, published in the June issue (PDF) of the Proceedings of the National Academy of Sciences, explains how a specifically targeted antimicrobial peptide, or STAMP, known as C16G2 works to eradicate only the harmful acid-producing Streptococcus mutans bacteria, the main cause of tooth decay, ...
Source: UCLA Newsroom: Health Sciences - June 3, 2015 Category: Universities & Medical Training Source Type: news
Aspyrian Therapeutics Inc. Announces FDA Acceptance of an Investigational New Drug Application for RM-1929, a First-in-Class, Precision-Targeted Therapy for Cancer
SAN DIEGO, May 12, 2015 -- (Healthcare Sales & Marketing Network) -- Aspyrian Therapeutics Inc., a drug development company creating precision-targeted therapies to treat cancer based on its proprietary Photoimmunotherapy platform, today announced the U.S... Biopharmaceuticals, Oncology, FDAAspyrian Therapeutics, Photoimmunotherapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 12, 2015 Category: Pharmaceuticals Source Type: news
Retrophin gets FDA nod to begin Phase I trial of phosphopantothenate replacement therapy
The US Food and Drug Administration (FDA) has reviewed Retrophin's investigational new drug (IND) application for RE-024, a new phosphopantothenate replacement therapy, and granted clearance to begin a Phase I clinical trial in healthy adult voluntee… (Source: Drug Development Technology)
Source: Drug Development Technology - April 30, 2015 Category: Pharmaceuticals Source Type: news
Bristol-Myers Squibb Announces Opening of Expanded Access Program for Elotuzumab
Bristol-Myers Squibb (BMS) has opened an expanded access protocol for its monoclonal antibody elotuzumab in combination with Revlimid® and dexamethasone. Expanded access is a process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. ?While data from a large, phase III randomized trial comparing elotuzumab plus Rev/dex versus Rev/dex alone is eagerly anticipated, in the interim patients may now enroll at an available site for access to this new combination therapy....
Source: International Myeloma Foundation - April 17, 2015 Category: Hematology Source Type: news
Horizon Pharma plc Submits Investigational New Drug Application for ACTIMMUNE(R) in the Treatment of Friedreich's Ataxia
Phase 3 Study Expected to Begin in Q2 2015
DUBLIN, IRELAND--(Healthcare Sales & Marketing Network) - Horizon Pharma plc (HZNP), a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commerci... Biopharmaceuticals, Neurology, FDAHorizon Pharma, ACTIMMUNE, Friedreich's Ataxia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2015 Category: Pharmaceuticals Source Type: news
MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials
(University of Texas M. D. Anderson Cancer Center) When cancer patients take part in a clinical trial to develop new therapies, they and their physicians want to know how they will feel and function during treatment. A new collaboration between Bayer and The University of Texas MD Anderson Cancer Center will go straight to the patients to learn how certain investigational new drugs affect them. The project will involve the use of questionnaires to assess how a drug may impact a patient's disease-related symptoms. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - January 23, 2015 Category: Cancer & Oncology Source Type: news
Advaxis to begin Phase I/II combination prostate cancer trial of ADXS-PSA and Keytruda
US-based biotechnology firm Advaxis has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start a Phase I/II clinical trial to evaluate the combination of ADXS-PSA (ADXS31-142) wit… (Source: Drug Development Technology)
Source: Drug Development Technology - December 10, 2014 Category: Pharmaceuticals Source Type: news
PPMD Awards Akashi Therapeutics, Inc. $500,000 Grant
Parent Project Muscular Dystrophy (PPMD) has awarded Akashi Therapeutics, Inc. (Akashi) a $500,000 grant to fund clinical trials to test the safety and efficacy of an investigational new drug known as HT-100 (delayed-release halofuginone).
HT-100 is an orally available small molecule drug candidate being developed to reduce fibrosis and inflammation and to promote healthy muscle fiber regeneration in Duchenne patients. The application of HT-100 to Duchenne and other fibrotic diseases is based on pioneering work by Dr. Mark Pines at the Volcani Institute in Israel. Akashi, led by CEO Marc Blaustein, has been granted orphan ...
Source: Parent Project Muscular Dystrophy - December 8, 2014 Category: Neurology Source Type: news
Minerva Neurosciences Announces Completion of FDA Review of Investigational New Drug Application for MIN-202 and Plans for First U.S.-Based Clinical Trial
(Source: Medical News (via PRIMEZONE))
Source: Medical News (via PRIMEZONE) - September 22, 2014 Category: Pharmaceuticals Source Type: news
FDA News Roundup: Astellas, Sanofi Pasteur, Orexigen, and More
Biopharmaceutical company Molecular Templates got a nod of approval from the FDA on its Investigational New Drug (IND) application for MT-3724 last week. MT-3724 is a next-generation immunotoxin compound that induces direct cell death by inactivating ribosomes in CD20-expressing cells. Now that approval has been granted, the company plans to launch a phase 1 clinical trial program for the drug candidate, investigating its potential as a monotherapy in refractory non-Hodgkin’s lymphoma. The study will be held at Memorial Sloan-Kettering Cancer Center and New York University’s Langone Medical Center, joined event...
Source: Pharmaceutical Online News - September 15, 2014 Category: Pharmaceuticals Source Type: news
Aeolus submits IND for radiation protection drug
Aeolus Pharmaceuticals has filed an investigational new drug (IND) application (more) (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 21, 2014 Category: Radiology Source Type: news
PTC Therapeutics begins Phase III trial of Translarna to treat nonsense mutation cystic fibrosis
US-based biopharmaceutical firm PTC Therapeutics has started a global confirmatory Phase III clinical trial of Translarna (ataluren), an investigational new drug, in patients with nonsense mutation cystic fibrosis (nmCF). (Source: Drug Development Technology)
Source: Drug Development Technology - June 30, 2014 Category: Pharmaceuticals Source Type: news
