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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]
Researchers report that predominant CA-MRSA strain migrated from sub-Saharan Africa

Researchers report that predominant CA-MRSA strain migrated from sub-Saharan Africa

The predominant strain of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) infecting people in Europe, the Middle East and northern Africa derived from a single sub-Saharan ancestor, a team of international researchers reported this week in mBio-, the online open-access journal of the American Society for Microbiology. [More]

NEOMED gets $12 million to support academic researchers on drug development

NEOMED, a not-for-profit organization whose mission is to create a bridge between academic research and the pharmaceutical industry, will receive $12 million in funding from the Government of Canada to help academic researchers turn their early discoveries into future medicines. [More]
FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection

FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection

ViiV Healthcare announced today that the US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. [More]