The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions.
BIND Therapeutics said Wednesday that Pfizer Inc. has agreed to pay it $160 million per drug as part of a collaboration to develop targeted medicines using nanotechnology which use particles measured in billionths of a meter. BIND is developing an experimental group of targeted, programmable...
The Food and Drug Administration on Friday approved a first-of-its-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar—flushing it out in patients' urine. The agency cleared J&J's Invokana tablets for adults with Type 2 diabetes, which affects an estimated 26 million Americans. The once-a-day medication works by blocking the kidneys from reabsorbing sugar, which occurs at higher levels in patients with diabetes than in healthy patients.
The Food and Drug Administration has approved a new imaging drug to help doctors locate lymph nodes in patients with breast cancer and skin cancer. The drug Lymphoseek from Navidea Biopharmaceuticals Inc. is a radioactive imaging agent that is intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes.
Biogen Idec has filed for federal marketing approval of a longer-lasting treatment for hemophilia A. Biogen says the drug rFVIIIFc can be injected once or twice a week, while other treatments for hemophilia A need to be injected three or four times a week. The drug could be the first major advance in the treatment of hemophilia in more than 20 years.
India's patent appeals office has rejected Bayer AG's plea to stop the production of a cheaper generic version of a patented cancer drug in a ruling that health groups say is an important precedent for getting inexpensive lifesaving medicines to the poor. Bayer sells a one month supply of the drug for about $5,600. Natco's version would cost Indian patients $175 a month, less than 1/30th as much.
Pharmaceutical residues in water can pose a danger to humans. Filtration is often very difficult as these trace substances, which are soluble in water, are so minute. Newly-developed double switchable membranes could make it possible to filter these molecules, as well as other biomolecules such as proteins and nucleic acids. The new membranes can reduce or enlarge pore size through changes in temperature and pH value.
Side effects are a major reason that drugs are taken off the market and a major reason why patients stop taking their medications, but scientists are now reporting the development of a new way to predict those adverse reactions ahead of time. The computer-based approach could save patients from severe side effects and save drug companies time and money.
Drug developer Eli Lilly and Co. is stopping clinical testing of an experimental rheumatoid arthritis treatment because it wasn't working. The Indianapolis company said Thursday it will continue studying the potential drug, tabalumab, as a possible treatment for a form of the autoimmune disorder lupus and the bone marrow cancer multiple myeloma.
French drugmaker Sanofi said Monday that the Food and Drug Administration will review its experimental multiple sclerosis treatment Lemtrada. Genzyme, Sanofi's U.S. biotech business, said the FDA will conduct a standard 10-month review and will make a decision on the drug in late 2013.
A series of papers published recently in the journal The Lancet are calling attention to the rapid spread of vector-borne, zoonotic diseases such as West Nile virus, dengue fever, and Lyme disease. These diseases, spread to humans by animals like mosquitos and ticks, are advancing as a result of urbanization, land use, and more intensive agricultural practices.
Researchers from North Carolina State University have increased the potency of a compound that reactivates antibiotics against methicillin-resistant Staphylococcus aureus (MRSA). Their improved compound removes the bacteria's antibiotic resistance and allows the antibiotic to once again become effective at normal dosage levels.
Using in silico computational tools to complement the results of in vivo and in vitro experiments, researchers at Pacific Northwest National Laboratory have revealed an atomic-level understanding of the mechanism by which nanoparticles inhibit the growth and metastasis of pancreatic tumors. The findings are promising for the development of particle-based therapies.
Research by scientists at the University of Bath is challenging claims that nanoparticles in medicated and cosmetic creams are able to transport and deliver active ingredients deep inside the skin. The study discovered that even the tiniest of nanoparticles did not penetrate the skin's surface.
Watch out, acne. Doctors soon may have a new weapon against zits: A harmless virus living on our skin that naturally seeks out and kills the bacteria that cause pimples. In the new findings, scientists looked at two little microbes that share a big name: Propionibacterium acnes , a bacterium thriving in our pores that can trigger acne, and P. acnes phages, a family of viruses that live on human skin.
U.K.-led scientists have made a discovery about snake venom that could lead to the development of new drugs to treat a range of life-threatening conditions. The researchers have discovered that the toxins that make snake and lizard venom deadly can evolve back into completely harmless molecules, raising the possibility that they could be developed into drugs.
Designed to improve the way businesses manage the scientific innovation lifecycle, the new Accelrys Process Management and Compliance Suite unifies Accelrys Inc.’s lifecycle management software offerings, covering the ground between product development and process execution. It is geared to help companies bring products to market faster and at a lower cost, while meeting critical quality and regulatory compliance objectives.
EMD Millipore and iPS Academia Japan Inc. (AJ) announced a global licensing agreement for AJ's induced pluripotent stem (iPS) cell patent portfolio. The non-exclusive agreement provides EMD Millipore the opportunity to continue to develop and ultimately commercialize iPS cells for research applications.
It's not a magic trick and it's not sleight of hand—scientists really are using levitation to improve the drug development process, eventually yielding more effective pharmaceuticals with fewer side effects. Scientists at Argonne National Laboratory have discovered a way to use sound waves to levitate individual droplets of solutions containing different pharmaceuticals.
According to data from a 2008 Business R&D and Innovation Survey by the National Science Foundation, businesses perform the lion's share of their R&D activity in just a small number of geographic areas, particularly the San Jose-San Francisco-Oakland area and the New York-Newark-Bridgeport area.
Time-consuming, expensive, and often intrusive, clinical trials are nevertheless a necessity. Researchers at the University of Tennessee Space Institute in Tullahoma have developed an invention that makes clinical trials more efficient. Called "digital Eye Bank," the computer software eye modeling program can take data from eyes of patients' and build it into models from the commercial optics program to be used for researchers' virtual clinical trials.
In a new study, University of Missouri medicinal chemists have taken an existing drug that is being developed for use in fighting certain types of cancer and added a special cluster of three elements: boron, carbon, and hydrogen. This structure, called a carborane, has multiplied the binding force of the drug. Clinical could start within two years.
A nanoparticle developed at Rice University and tested in collaboration with Baylor College of Medicine may bring great benefits to the emergency treatment of brain-injury victims, even those with mild injuries. Combined polyethylene glycol-hydrophilic carbon clusters (PEG-HCC), already being tested to enhance cancer treatment, are also adept antioxidants. In animal studies, injections of PEG-HCC during initial treatment after an injury helped restore balance to the brain's vascular system.
As the medical community continues to make positive strides in personalized cancer therapy, scientists know some dead ends are unavoidable. Drugs that target specific genes in cancerous cells are effective, but not all proteins are targetable. In fact, it has been estimated that as few as 10% to 15% of human proteins are potentially targetable by drugs. For this reason, Georgia Institute of Technology researchers are focusing on ways to fight cancer by attacking defective genes before they are able to make proteins.
One of the most daunting challenges facing pharmaceutical scientists today are "undruggable proteins"—the approximately 80% of proteins involved in human disease that do not interact with current drugs. Yale University researchers have identified a novel way to design drugs for these previously inaccessible proteins.