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.
India's patent appeals office has rejected Bayer AG's plea to stop the production of a cheaper...
Pharmaceutical residues in water can pose a danger to humans. Filtration is often very difficult...
Side effects are a major reason that drugs are taken off the market and a major reason why...
State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications. The head of the National Association of Boards of Pharmacy told Senate lawmakers that his group welcomes FDA action against pharmacies.
Bristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval expands the drug's use to children age three months to three years who weigh at least 7.7 pounds.
U.S. health officials are making a high-tech screening device available to African authorities to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade worldwide. The FDA announced Wednesday that regulators in Ghana will begin using a federally developed handheld device to screen for fake or diluted versions of two common malaria pills.
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.
Better cancer drugs that zero in on a tumor with fewer side effects. A universal flu vaccine that could fight every strain of influenza without needing a yearly shot. Research into potentially life-saving products like these will be delayed and newer discoveries shelved if Congress can't avert impending budget cuts that the director of the National Institutes of Health warns will have far-reaching effects.
Biotech giant Amgen Inc. and Belgian drugmaker UCB SA have scrapped plans for late-stage testing of an experimental treatment for accelerated healing of fractures, but will continue testing their drug for a much bigger and potentially lucrative market, treating osteoporosis in postmenopausal women.
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.
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.