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New consensus guidelines for toxicity testing of oligonucleotide-based therapeutics

New consensus guidelines for toxicity testing of oligonucleotide-based therapeutics

Oligonucleotide-based therapeutics present unique challenges when it comes to testing their potential to cause reproductive and developmental harm. New consensus guidelines for toxicity testing that take into consideration the combined chemical and biological characteristics of these novel biopharmaceuticals are presented in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers. [More]
Four ACS members named recipients of ACS/Pfizer Surgical Humanitarian and Volunteerism Awards

Four ACS members named recipients of ACS/Pfizer Surgical Humanitarian and Volunteerism Awards

Earlier this evening, four members of the American College of Surgeons were named recipients of the 2014 ACS/Pfizer Surgical Humanitarian and Volunteerism Awards in recognition of their selfless efforts as volunteer surgeons who provide care to medically underserved patients, domestically and abroad. [More]
MPI Research announces acquisition of Jasper Clinical Research & Development

MPI Research announces acquisition of Jasper Clinical Research & Development

MPI Research today announced it has acquired the assets of Kalamazoo, Mich.-based Jasper Clinical Research & Development, Inc. Jasper is a respected clinical research organization that provides early-stage human clinical testing of promising new drugs, and is well known to pharmaceutical and biotechnology companies worldwide. [More]
Actavis seeks FDA approval to market generic version of Quillivant XR

Actavis seeks FDA approval to market generic version of Quillivant XR

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR®, which is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder. [More]
Pharmaceutical industry withdraws from the antibiotic space

Pharmaceutical industry withdraws from the antibiotic space

The Centers for Disease Control and Prevention has said that at least 2 million Americans are sickened by antibiotic resistant infections each year and survive. [More]
Intensive parenting and education provided in homes reduces drug use in pregnant teens

Intensive parenting and education provided in homes reduces drug use in pregnant teens

Intensive parenting and health education provided in homes of pregnant American Indian teens reduced the mothers' illegal drug use, depression and behavior problems, and set their young children on track to meet behavioral and emotional milestones they may have otherwise missed. [More]
Halozyme's PEGPH20 receives FDA Orphan Drug designation for treatment of pancreatic cancer

Halozyme's PEGPH20 receives FDA Orphan Drug designation for treatment of pancreatic cancer

Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has granted Orphan Drug designation for PEGylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. [More]
Novel test could revolutionise discovery of new prescription drugs

Novel test could revolutionise discovery of new prescription drugs

A new test developed by researchers from the University of Manchester could revolutionise the discovery of new prescription drugs. The test will help determine which drugs are unlikely to work at an early stage, speeding up the time it takes to make safe and effective medicines available. [More]
Lpath closes $12.5 million registered direct offering

Lpath closes $12.5 million registered direct offering

Lpath, Inc., the industry leader in bioactive lipid-targeted therapeutics, announced today the closing of its previously announced $12.5 million registered direct offering. [More]
Lung-MAP, ALCHEMIST clinical trials offer innovative study designs for lung cancer patients

Lung-MAP, ALCHEMIST clinical trials offer innovative study designs for lung cancer patients

The recent launch of two clinical trials offer innovative study designs for patients with lung cancer. These clinical trials are the direct result of a National Cancer Institute sponsored workshop chaired by Drs. Fred R. Hirsch, Shakun Malik and Claudio Dansky- Ullman, that brought together the NCI Thoracic Malignancies Steering Committee, the US Food and Drug Administration, academicians, clinicians as well as industry and government stakeholders to discuss issues and challenges related to clinical trial design and biomarkers for lung cancer targeted-therapies. [More]
Crizotinib drug effectively halts growth of ROS1-positive lung tumors

Crizotinib drug effectively halts growth of ROS1-positive lung tumors

Treatment with the targeted therapy drug crizotinib effectively halts the growth of lung tumors driven by rearrangements of the ROS1 gene. In an article receiving Online First publication in the New England Journal of Medicine to coincide with a presentation at the European Society for Medical Oncology meeting, an international research team reports that crizotinib treatment led to significant tumor shrinkage in 36 of 50 study participants and suppressed tumor growth in another 9. [More]
MIT researchers use disarmed version of anthrax toxin to deliver cancer drugs

MIT researchers use disarmed version of anthrax toxin to deliver cancer drugs

Bacillus anthracis bacteria have very efficient machinery for injecting toxic proteins into cells, leading to the potentially deadly infection known as anthrax. A team of MIT researchers has now hijacked that delivery system for a different purpose: administering cancer drugs. [More]
NIH awards grants to 11 research groups to establish AMP RA/Lupus Network

NIH awards grants to 11 research groups to establish AMP RA/Lupus Network

The National Institutes of Health has awarded grants to 11 research groups across the United States to establish the Accelerating Medicines Partnership in Rheumatoid Arthritis and Lupus (AMP RA/Lupus) Network. [More]
National health research forum

National health research forum

Leaders from government, industry, academia and patient advocacy organizations will explore the future of R&D investments, policy trends, public-private partnerships, public health and social sciences research, global health threats and other timely medical and health research issues in panel discussions hosted by Research!America. [More]
Neuroscientist discovers new mechanism that can reverse chronic pain

Neuroscientist discovers new mechanism that can reverse chronic pain

It's in the brain where we perceive the unpleasant sensations of pain, and researchers have long been examining how calcium channels in the brain and peripheral nervous system contribute to the development of chronic pain conditions. [More]
Permanent atrial fibrillation twins risk of stroke than paroxysmal AF

Permanent atrial fibrillation twins risk of stroke than paroxysmal AF

Permanent atrial fibrillation (AF) doubles the risk of stroke compared to paroxysmal AF, according to research in more than 6 000 patients presented at ESC Congress today by Dr Thomas Vanassche from Belgium. The findings suggest that a simple clinical assessment of the type of AF can help doctors to better estimate stroke risk. [More]
InnoPharma receives FDA approval for generic DACOGEN

InnoPharma receives FDA approval for generic DACOGEN

InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN. [More]
Research report: Orphan Diseases Partnering Terms and Agreements

Research report: Orphan Diseases Partnering Terms and Agreements

The Orphan Diseases Partnering Terms and Agreements report provides an understanding and access to the orphan diseases partnering deals and agreements entered into by the worlds leading healthcare companies. [More]
Scientists pave way for improved tools to diagnose, predict and monitor cancer

Scientists pave way for improved tools to diagnose, predict and monitor cancer

Scientists have shown how to better identify and measure vital molecules that control cell behaviour - paving the way for improved tools for diagnosis, prediction and monitoring of cancer. [More]
Scientists pave way for improved tools to predict and monitor cancer

Scientists pave way for improved tools to predict and monitor cancer

Scientists have shown how to better identify and measure vital molecules that control cell behaviour - paving the way for improved tools for diagnosis, prediction and monitoring of cancer. [More]