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Effectiveness prompts Novartis to end drug study

March 31, 2014 10:23 am | by The Associated Press | News | Comments

Novartis said it's cutting off late-stage research into a potential chronic heart failure treatment because the drug has proven so effective, sending shares to an all-time high when markets opened Monday. Patients taking its twice-daily pill labeled LCZ696 lived longer without being hospitalized for heart failure than those who received a standard of care, Novartis said.

U.S. network to scan workers with secret clearances

March 10, 2014 9:49 am | by Stephen Braun, Associated Press | News | Comments

Intelligence officials are planning a sweeping...

FDA clears Pharmacyclics drug for new cancer use

February 12, 2014 2:09 pm | by The Associated Press | News | Comments

The Food and Drug Administration on Wednesday approved a cancer drug from Pharmacyclics and...

Panel votes down heart safety claim for naproxen

February 11, 2014 2:09 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

A majority of federal health experts said Tuesday that new research is not strong enough to...

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FDA reconsiders heart safety of common pain pills

February 10, 2014 1:08 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Federal health experts are taking a second look this week at the heart safety of pain medications used by millions of Americans to treat arthritis and other everyday aches and pains. The Food and Drug Administration holds a two-day meeting beginning Monday to examine the latest research on anti-inflammatory medicines called NSAIDS, which serve as the backbone of U.S. pain treatment.

Pharma data play larger role in Olympic drug tests

February 10, 2014 7:48 am | by Matthew Perrone, AP Health Writer | News | Comments

Some of the world's biggest drugmakers are playing a larger role in anti-doping efforts at this year's Winter Olympics: They're providing information on drugs that once would have been considered proprietary trade secrets. GlaxoSmithKline, Amgen and Roche are among the drugmakers that have begun sharing data about experimental drugs as part of an effort to stay one step ahead of drug cheats.

First guidelines issued to prevent stroke in women

February 6, 2014 4:09 pm | by Marilynn Marchione - AP Chief Medical Writer - Associated Press | News | Comments

Just as heart attack symptoms may differ between men and women, so do stroke risks. Now, the American Heart Association has issued its first guidelines for preventing strokes in women. They focus on birth control, pregnancy, depression and other risk factors that women face uniquely or more frequently than men do.

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U.S. warns of explosives in toothpaste tubes

February 5, 2014 7:08 pm | by Alicia A. Caldwell - Associated Press - Associated Press | News | Comments

The U.S. Homeland Security Dept. is warning airlines flying to Russia that terrorists may try to smuggle explosives on board hidden in toothpaste tubes. The threat was passed onto airlines that have direct flights to Russia, including some that originate in the U.S., according to a law enforcement official speaking Wednesday on condition of anonymity because he was not authorized to discuss details of the warning.

FDA reviews safety of testosterone therapy for men

January 31, 2014 7:08 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration said Friday it is reviewing the safety of popular testosterone drugs for men in light of recent studies suggesting they can increase the risk of heart attack, stroke and death. A study suggested testosterone therapy could double the risk of those problems in men older than 65. Another study published in November found that the hormone increased the risk by 30%.

All FDA drug approvals not created equal

January 22, 2014 8:21 am | by Karen N. Peart, Yale Univ. | News | Comments

Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the U.S. Food and Drug Administration (FDA). But a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.

Merck blood thinner gets "yes" vote from FDA panel

January 15, 2014 5:10 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding. The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.

Self-driving vehicles offer potential benefits, challenges for lawmakers

January 6, 2014 8:38 am | News | Comments

New research finds that the social benefits of autonomous vehicles will outweigh the likely disadvantages. Decreased crashes, increased mobility, and increases in fuel economy will drive the technology forward, says RAND Corp. researchers, despite privacy concerns and need for updates in insurance regulations.

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U.S. opens door to new herbicide-resistant seeds

January 3, 2014 11:38 am | by M.L. Johnson, Associated Press | News | Comments

The U.S. Department of Agriculture opened the door Friday to commercial sales of corn and soybean seeds genetically engineered to resist the weed killer 2,4-D, which is best known as an ingredient in the Vietnam War-era herbicide Agent Orange. The U.S. military stopped using Agent Orange in 1971, and it has not been produced since the 1970s.

FDA extends review of Biogen hemophilia B drug

December 2, 2013 9:19 am | by The Associated Press | News | Comments

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 receives FDA clearance to market MALDI Biotyper CA System

November 27, 2013 11:52 am | News | Comments

Bruker Corp. has announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens. The clearance marks progress in Bruker’s efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

FDA tells 23andMe to halt sales of genetic test

November 26, 2013 11:57 am | by Matthew Perrone, AP Health Writer | News | Comments

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."

How Dead Data is Killing Productivity in the Lab

November 20, 2013 11:20 am | by Ryan Sasaki, Director of Global Strategy, ACD/Labs | Articles | Comments

Within the pharmaceutical industry, the rapid identification, elucidation and characterization of synthetic, process impurities and degradation products is an intense and comprehensive undertaking. In the development of a formulated drug substance, the U.S. Food and Drug Administration (FDA) requires that all impurities introduced in the proposed process above 0.1% must be isolated and fully characterized.

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Japan dials back climate change emissions target

November 15, 2013 11:22 am | by Associated Press | News | Comments

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.

FDA approves new drug for rare blood cancer

November 13, 2013 2:46 pm | by The Associated Press | News | Comments

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.

Study: Better police surveillance technologies come with a cost

November 11, 2013 2:07 pm | by Phil Ciciora, Business & Law Editor, Univ. of Illinois | News | Comments

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.

Study: Hefty soda tax would reduce U.K. obesity

October 31, 2013 7:31 pm | by MARIA CHENG - AP Medical Writer - Associated Press | News | Comments

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.

Public wants labels for food nanotech

October 28, 2013 7:51 am | News | Comments

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.

U.S. approves more powerful, pure hydrocodone drug

October 25, 2013 5:39 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

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.

FDA issues positive review for Gilead's hep C drug

October 23, 2013 10:00 am | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

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.

Panel rejects broader use of Amarin fish oil drug

October 16, 2013 3:37 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

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 says FDA approves lung disease drug Adempas

October 9, 2013 9:58 am | by The Associated Press | News | Comments

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.

U.S. approves first pre-surgical breast cancer drug

September 30, 2013 1:12 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

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.

Obama moves to limit power-plant carbon pollution

September 20, 2013 3:40 pm | by DINA CAPPIELLO - Associated Press - Associated Press | News | Comments

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.

FDA panel backs drug for early-stage breast cancer

September 12, 2013 2:52 pm | by The Associated Press | News | Comments

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.

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