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.
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.
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.
At the start of a major conference to regulate chemical and hazardous waste safety, top officials voiced optimism Saturday that delegates will approve new international controls on several industrial compounds and agree to clamp down on some cross-border pollution.
Nanotechnology typically describes any material, device, or technology where feature sizes are smaller than 100 nanometers in dimension. However, this new and uncharted direction in research provides a large spark for new product and drug delivery development. To achieve these discoveries, scientists must rely on specialized instruments and materials to drive their experiments and analysis.
A U.N. nuclear watchdog team said Japan may need longer than the projected 40 years to decommission its tsunami-crippled nuclear plant and urged its operator to improve plant stability. Damage at the Fukushima Dai-ichi plant is so complex that it is "impossible" to predict how long the cleanup may last.
A plan by California and Canadian universities to build the world's largest telescope at the summit of Hawaii's Mauna Kea volcano won approval from the state Board of Land and Natural Resources on Friday, clearing the way for a land lease negotiation. The telescope, with its proposed 30-m long segmented primary mirror, should help scientists see some 13 billion light years away.
DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly? The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multibillion-dollar medical and biotechnology business.
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.
Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90%.
The European Union has fined Microsoft €561 million ($733 million) for breaking a pledge to offer personal computer users a choice of Internet browsers when they install the company's flagship Windows operating system. The penalty imposed by the EU's executive arm, the Commission, is a first for Brussels: no company has ever failed to keep its end of a bargain with EU authorities before.
The U.S. Department of Energy announced that its support for a decade of revolutionary research has contributed to the creation of the first-ever retinal prosthesis, or bionic eye, to be approved in the United States by the U.S. Food and Drug Administration for blind individuals with end-stage retinitis pigmentosa. The artificial retina, dubbed the Argus II Retinal Prosthesis System, a previous R&D 100 winner, can partially restore the sight of blind individuals after surgical implantation.
A U.N. agency that sets global aviation safety standards is moving to prevent aircraft batteries like the one that caught fire on a Boeing 787 last month from being shipped as cargo on passenger planes, people familiar with the effort said.
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.
U.N. officials say more than 130 nations have adopted the first legally binding international treaty aimed at reducing mercury emissions. The U.N. Environment Program says the treaty was adopted Saturday morning, after all-night negotiations that capped a week of talks.
A California judge has tentatively ruled in favor of NASA's Jet Propulsion Laboratory in a wrongful termination lawsuit brought by a former computer specialist who alleged he was singled out in part because of his belief in intelligent design.
From Napster to iTunes to Pandora, the methods by which the public can obtain and share music have rapidly progressed. Future groundbreaking innovations may need to wait, though, as the next generation of technology is being stymied by the very copyright laws that seek to protect the industry, says Rutgers-Camden University professor Michael Carrier in a new article for a law journal..
The U.S. Environmental Protection Agency has completed and published a comprehensive environmental assessment (CEA) framework study of engineered nanoscale silver, specifically with regard to its behavior in disinfectant sprays. Though not a formal assessment, many factors such as product life cycle, environmental transport and fate, exposure-dose in receptors, and potential impacts in these receptors are covered in the report.
Is gas drilling ruining the air, polluting water and making people sick? The evidence is sketchy and inconclusive, but a lack of serious funding is delaying efforts to resolve those pressing questions and creating a vacuum that could lead to a crush of lawsuits, some experts say.