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.
Bruker Corp. has announced that it has been...
The Food and Drug Administration has ordered...
Activists taking part in U.N. climate talks say Japan's decision to drastically scale back its target for reducing greenhouse gas emissions will hurt the battle against global warming. The new target approved by the Japanese Cabinet calls for reducing emissions by 3.8% from their 2005 level by 2020.
The U.S. Food and Drug Administration has approved a new drug from Pharmacyclics and Janssen Biotech Inc. to treat a rare and aggressive form of blood cancer. The agency says it approved Imbruvica for patients with mantle cell lymphoma who have already received at least one previous drug therapy.
The widespread use of advanced surveillance technologies by state and local police departments will improve the efficiency of criminal investigations. But a lack of oversight and regulation poses significant privacy concerns, warns Stephen Rushin, a professor of law at the Univ. of Illinois.
Slapping a 20% tax on soda in Britain could cut the number of obese adults by about 180,000, according to a new study. Though the number works out to a modest drop of 1.3% in obesity, scientists say that reduction would still be worthwhile in the U.K., which has a population of about 63 million and is the fattest country in Western Europe. About one in four Britons is obese.
New research from North Carolina State Univ. and the Univ. of Minnesota finds that people in the U.S. want labels on food products that use nanotechnology—whether the nanotechnology is in the food or is used in food packaging. The research also shows that many people are willing to pay more for the labeling.
The U.S. Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely abused prescription painkiller. The agency said it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.
The U.S. Food and Drug Administration has issued a positive review for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments. The agency posted its review of Gilead's sofosbuvir online ahead of a meeting Friday where government experts will vote on whether to recommend the drug's approval.
Federal health advisers dealt a major blow to specialty drugmaker Amarin Corp., saying that the government should delay expanding approval of the company's prescription fish-oil drug until more patient data is available. The U.S. Food and Drug Administration's panel of outside advisers voted 9-2 against recommending broader use of Vascepa, a form of fish oil designed to lower triglycerides, a type of fat in the bloodstream.
Bayer HealthCare said Tuesday its drug Adempas has been approved as a treatment for two types of pulmonary hypertension, or high blood pressure in the arteries of the lungs. Bayer said it is already launching the drug, and called Adempas the first drug approved by the Food and Drug Administration as a treatment for more than one type of the disease.
A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease. The U.S. Food and Drug Administration (FDA) approved Perjeta for women with a form of early-stage breast cancer who face a high risk of having their cancer spread to other parts of the body.
Linking global warming to public health, disease and extreme weather, the Obama administration pressed ahead Friday with tough requirements to limit carbon pollution from new power plants, despite protests from industry and Republicans that it would dim coal's future. The proposal, which would set the first national limits on heat-trapping pollution from future power plants, is intended to help reshape where Americans get electricity.
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.
The U.S. Environmental Protection Agency (EPA) has launched a web-based tool, called ChemView, to significantly improve access to chemical specific regulatory information developed by EPA and data submitted under the Toxic Substances Control Act. The tool displays key health and safety data in an online format that allows comparison of chemicals by use and by health or environmental effects.
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.
Pharmacyclics is getting a priority review of its blood cancer treatment by federal regulators. A priority review shortens a drug evaluation by the U.S. Food and Drug Administration from 10 months to six. The acceptance of the application triggers a $75 million milestone payment to Pharmacyclics from Johnson & Johnson's Janssen unit.
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.
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.
eBay Inc.'s payments business, PayPal, says it is launching an initiative called PayPal Galactic with the help of the nonprofit SETI Institute and the Space Tourism Society, an industry group focused on space travel. Its goal, PayPal says, is to work out how commerce will work in space. In addition to regulatory and technical issues, even the currency that is to be used is up for debate.
Dassault Systèmes, a maker of solutions for 3-D design and product lifecycle management, has launched a new industry solution experience for pharmaceutical and biotech companies, called “Licensed to Cure for BioPharma.” Based on Dassault Systèmes’ 3DEXPERIENCE platform, the new solution helps biotech and pharmaceutical companies manage product and process complexity by smoothing drug variation, enabling easier and faster expansion into new markets, and managing increasing regulatory requirements.
It's official: The National Institutes of Health plans to end most use of chimpanzees in government medical research, saying humans' closest relatives "deserve special respect." The NIH announced Wednesday that it will retire about 310 government-owned chimpanzees from research over the next few years, and keep only 50 others essentially on retainer.
Theoretically, hydropower can step in when wind turbines go still, but barriers to this non-polluting resource serving as a backup are largely policy- and regulation-based, according to Penn State Univ. researchers. The U.S. Dept. of Energy recently examined the feasibility of producing 20% of U.S. electricity from wind by 2030.
The U.S. Supreme Court ruled Thursday that companies cannot patent parts of naturally-occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. The high court's unanimous judgment reverses three decades of patent awards by government officials.
Agilent Technologies Inc. announced that the majority of its electronic test and measurement products are now designed for compliance with the European Union’s restrictions on the use of certain hazardous substances in electrical and electronic equipment. Commonly referred to as RoHS, the European directive bans the sale of equipment containing more than the agreed level of lead, mercury, cadmium and other substances.
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