Biogen Idec said Monday the U.S. Food and Drug Administration (FDA) extended its review of Alprolix, a drug designed to treat hemophilia B. Biogen Idec said the FDA extended its review by three months. The move came after the agency asked Biogen for more information about validation of part of the Alprolix manufacturing process.
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits. In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges."
Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery. The U.S. Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.
Federal regulators have approved Celgene Inc.'s drug Abraxane to treat late-stage pancreatic cancer. In experimental trials, the drug extended the lives of patients by a little less than two months more than those treated with the current standard drug.
Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. When an adverse event or device malfunction occurs, hospitals are required to report these incidents. But this doesn’t always happen, the researchers say.
Scientists estimate that there is a minimum of 320,000 viruses in mammals awaiting discovery. Collecting evidence of these viruses, or even a majority of them, they say, could provide information critical to early detection and mitigation of disease outbreaks in humans. This undertaking would cost approximately $6.3 billion, or $1.4 billion if limited to 85% of total viral diversity.
Onyx Pharmaceuticals and Bayer said Tuesday that regulators will conduct a faster review of their pill Nexavar as a treatment for thyroid cancer. The U.S. Food and Drug Administration (FDA) is reviewing Nexavar as a treatment for locally advanced or metastatic thyroid cancer that doesn't respond to treatment with radioactive iodine. The companies said the FDA expects to complete its review by Dec. 25. to.
The overall dropout rate for oncology Phase I trials is very low at only 8%, a study by Cutting Edge Information found. However dropout rates tend to rise as the number of required visits increases. The study discovered that the average number of patients enrolled for these trials across all therapeutic areas is 47.2.
Some 60 years ago, a doctor in Baltimore removed cancer cells from a poor black patient named Henrietta Lacks without her knowledge or consent. Those cells eventually helped lead to a multitude of medical treatments and lay the groundwork for the multibillion-dollar biotech industry. Now, for the first time, the Lacks family has been given a say over at least some research involving her cells.
A study at the Univ. of Utah finds that more than 60% of antibiotic prescriptions are for types that kill multiple kinds of bacteria. Unfortunately, in more than 25% of cases such prescriptions are useless because the infection stems from a virus, which cannot be treated with antibiotics. This overuse of antibiotics has a number of downsides.
Chances are that about 15% of the food you eat—more if your diet includes lots of fruits, vegetables and cheese—comes from abroad, and the government is taking steps now to make it safer. New rules proposed Friday by the U.S. Food and Drug Administration would make U.S. food importers responsible for ensuring that their foreign suppliers are handling and processing food safely.
A free trade pact being negotiated by the U.S. and 11 Asia-Pacific nations will impose aggressive intellectual property rules that will restrict access to affordable medicines in developing nations, health activists warned Wednesday. The 12 countries will start an 18th round of talks in Malaysia on July 15 and hope to complete negotiations by October.
Health care spending is much higher for older Americans than for younger adults and children, on average, and analysts have said that increasing spending leads to longer life expectancy. But new research from the University of Michigan indicates that aging populations could view things differently.
Cancer patients could face high costs for medications under President Barack Obama's health care law, industry analysts and advocates warn. Where you live could make a huge difference in what you'll pay. To try to keep premiums low, some states are allowing insurers to charge patients a hefty share of the cost for expensive medications used to treat cancer, multiple sclerosis, rheumatoid arthritis, and other life-altering chronic diseases.
For the first time, researchers from institutions around the country have conducted an identical series of toxicology tests evaluating lung-related health impacts associated with widely used engineered nanomaterials (ENMs). The study provides comparable health risk data from multiple laboratories, which should help regulators develop policies to protect workers and consumers who come into contact with ENMs.
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.
A new global plan aims to end most cases of polio by late next year, and essentially eradicate the paralyzing disease by 2018 — if authorities can raise the $5.5 billion needed to do the work, health officials said Tuesday. Part of the challenge will be increasing security for vaccine workers who have come under attack in two of the hardest-hit countries. And the plan calls for changing how much of the world protects against polio, phasing out the long-used oral vaccine in favor of a pricier but safer shot version.
President Barack Obama on Tuesday asked Congress to spend $100 million next year on a new project to map the human brain in hopes of eventually finding cures for disorders like Alzheimer's, epilepsy and traumatic injuries. The BRAIN Initiative, he said, could create jobs and eventually lead to answers to ailments including Parkinson's and autism and help reverse the effect of a stroke.
Have you ever had a fighter jet fly over your home and the noise of the aircraft booms loud enough to rattle the windows? Imagine working on an aircraft carrier or air base, up close to the engines as they take off or land. Several U.S.-based research teams, with the support of the Office of Naval Research, have been tasked with finding a way to reduce that deafening noise as part of a three-year project.
Facing public outrage over smog-choked cities and filthy rivers, China's leaders are promising to clean up the country's neglected environment—a pledge that sets up a clash with political pressures to keep economic growth strong.
According to a recent study from Rice University and the U.S. Environmental Protection Agency, there is good news and better news about ground-level ozone in American cities. While dangerous ozone levels have fallen in places that clamp down on emissions from vehicles and industry, the report suggests that a model widely used to predict the impact of remediation efforts has been too conservative.
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.
The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung, kidney, and brain.
Claiming that recent product recalls and bans indicate that product manufacturers do not have adequate tools for identifying and avoiding the use of harmful chemicals in their products, a group of scientists from North America and Europe has developed a five-tiered testing system that manufacturers can use to ensure that the consumer products they produce are free of endocrine disrupting chemicals like BPA or DDT.
Mosquito control officials in the Florida Keys are waiting for the federal government to sign off on an experiment that would release hundreds of thousands of genetically modified mosquitoes to reduce the risk of dengue fever in the tourist town of Key West. If approved by the Food and Drug Administration, it would be the first such experiment in the U.S. Some residents, however, are worried about the risks.