FDA staff review raises questions about MannKind diabetes device

A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver SpringBy Toni Clarke WASHINGTON (Reuters) – A review of MannKind Corp's experimental inhaled insulin device by U.S. Food and Drug Administration staff raised questions about its safety and effectiveness but was less damning than some investors had expected. The company's shares initially rose as much as 10.6 percent before falling back amid conflicting opinions from analysts on how the FDA will likely rule. The reviewers issued their report ahead of a meeting on Tuesday of outside advisers to the FDA, who will discuss clinical trial data and advise on whether the product, Afrezza, should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

GM stops selling some Cruze small cars, offering no reason

Cristi Landy, Chevrolet marketing director for small cars speaks during the debut of the 2014 Chevy Cruze Clean Turbo Diesel at the Chicago Auto Show in this file photoBy Ben Klayman DETROIT (Reuters) – General Motors Co said on Friday it had told its dealers to stop selling certain Chevrolet Cruze small cars without saying why, in another blow to a company already facing a crisis over defective ignition switches linked to at least 12 deaths. The automaker said the affected Cruze cars, 2013 and 2014 models equipped with a 1.4-liter turbo engine, are not being recalled. The action only covers the affected models that are unsold on dealer lots, which make up about one-third of the vehicle's inventory at dealers, a GM spokesman said. The 1.4-liter gas turbo engine accounts for about 60 percent of the Cruze's retail sales mix in any given month, a GM spokesman said.

U.S. wants at least $1 billion from drugmakers who delay generics

By David Ingram WASHINGTON (Reuters) – The U.S. Federal Trade Commission seeks a settlement of $1 billion or more from pharmaceutical companies it has sued for delaying the sale of cheaper medicines after patents on brand-name drugs may have expired, an FTC official told a legal conference on Friday. In the settlements, makers of brand-name drugs pay millions of dollars to generics companies while they delay putting their products on the U.S. market. A panel moderator at the American Bar Association’s spring antitrust meeting asked Deborah Feinstein, the director of the FTC’s Bureau of Competition, what developments to expect in the coming year. “The consumer harm there is extremely significant, and so we have a tremendous amount of resources there and hope to come out with a victory one way or another in those cases.” Defendants in the lawsuits include Solvay Pharmaceuticals Inc, owned by AbbVie Inc;

White House unveils plan to cut methane from oil, gas sector

A view of the White House as snow begins to fall during expected blizzard in Washington DCThe White House said on Friday it will take a hard look at whether new regulations are needed to cut emissions of methane from the oil and gas industry, part of President Barack Obama's plan to address climate change. Regulators will start by proposing new rules later this year to reduce venting and flaring from oil and gas wells on public lands, said Dan Utech, Obama's top energy and climate aide. The Environmental Protection Agency is going to study this year whether additional broader regulations are needed for methane emissions under the Clean Air Act, Utech told reporters.

Eating cruciferous vegetables may lower inflammation

By Shereen Jegtvig NEW YORK (Reuters Health) – In a study of more than 1,000 Chinese women, those who ate the most cruciferous vegetables had substantially less inflammation than those who ate the fewest. Cruciferous vegetables include cabbage, broccoli, bok choy, Brussels sprouts, kale and cauliflower, and eating them is often encouraged as a way to lower risk for heart disease and cancer. Based on their findings, the study authors say the health benefits of these vegetables may be at least partly a result of their anti-inflammatory effects. “Our group and others have found that consumption of fruits and vegetables, particularly cruciferous vegetables, was associated with lower total mortality and cardiovascular disease mortality – however, the potential mechanisms behind this association are not well understood,” Dr. Gong Yang told Reuters Health by email.

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