Filed under: Pharmaceuticals

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Amgen recalls anemia drugs over glass concerns

Amgen Inc. is recalling hundred of lots of anemia drugs Epogen and Procrit, sold by Johnson & Johnson, because vials of the injectable medicines might develop tiny glass flakes that could cause blood clots and other serious health problems.

Amgen, which sells Epogen, makes the identical drugs at a plant in Puerto Rico. Get the full story »

Abbott strikes deal for kidney drug

Abbott Laboratories has agreed to pay at least $450 million for international rights to develop and commercialize Reata Pharmaceuticals Inc.’s experimental chronic kidney-disease drug bardoxolone. Get the full story »

10% hikes seen in Medicare drug coverage next year

A new analysis of government data finds that millions of seniors face double-digit hikes in their Medicare prescription premiums next year unless they shop for cheaper coverage. Get the full story »

Avandia faces ban in Europe, severe limits in U.S.

European regulators said Thursday GlaxoSmithKline’s diabetes drug Avandia should be taken off the market but U.S. officials allowed it to stay, with major restrictions due to concerns about heart risks.

The differing rulings were an attempt to end a row over drug safety that has dogged the reputation of the medicine and its maker in recent years. Get the full story »

Few answers at Similac recall Web site, hot line

Abbott Laboratories created a Web site for parents and caregivers to check whether their baby formula was affected by Wednesday’s Similac recall.

But families swamped the site and phone hot line Thursday, only to meet a dead end. The overwhelming surge of traffic resulted in busy lines and site problems, leaving parents frustrated by the company’s lack of response. Get the full story »

J&J lawyers: U.S. knew of Motrin ‘phantom recall’

U.S. health regulators knew that Johnson & Johnson’s McNeil unit was using a contractor to buy back potentially faulty batches of Motrin, though there was no formal agreement with the government, lawyers for the company told lawmakers.

Still, in a letter to the House Oversight and Government Reform Committee Wednesday, J&J’s lawyers said though the purchases of defective painkiller  from retailers were legal, “moving forward the company would handle things differently.” Get the full story »

Abbott to cut 3,000 jobs globally, none in Lake Co.

Drug and medical product giant Abbott Laboratories said this morning it would cut about 3,000 jobs worldwide. But there will be no reductions in Lake County, home to the company’s sprawling Abbott Park headquarters.

The cuts, which amount to about 3 percent of its global workforce, come in the wake of its acquisition earlier this year of Solvay SA’s drug business. Abbott has 93,000 employees worldwide, including 13,000 in Illinois that are largely at its campus just east of the Tri-State Tollway. Get the full story »

Weight-loss drug show strong results as FDA set to rule

An experimental weight-loss drug made by Vivus Inc. helped obese people lose more than 10 percent of their weight after two years in a clinical trial, but safety details were scant for the drug, which in July was turned down by a panel of U.S. experts.

The company said Tuesday that the second year of a clinical trial found that patients taking the highest dose of its drug, Qnexa, lost an average of 26 pounds, or 11.4 percent of their body weight. Patients taking a placebo had weight loss of 2.5 percent. Get the full story »

Prescription business brisk in 2Q

Prescriptions increased in the second quarter for some of the largest U.S. drugstores and pharmacy benefits managers despite the weak economy, an analyst for Fitch Ratings said Friday.

Analyst Bob Kirby said prescriptions for Medco Health Solutions Inc. and Express Scripts Inc. and for the drugstores Walgreen Co. and CVS Caremark Corp. rose 5.2 percent from a year earlier. Kirby said he expects similar growth for the rest of the year assuming economic conditions don’t change much. Get the full story »

FDA looks into diabetes drug, bladder cancer

The Food and Drug Administration said Friday that it has started a safety review of Takeda Pharmaceutical Co.’s  diabetes drug Actos looking at links to bladder cancer.

The FDA said the review was prompted from preliminary, five-year data from an ongoing study involving the drug. The study, designed to follow patients for 10-years, is being funded by Takeda. Get the full story »

J&J eyes vaccine maker Crucell

U.S. health care company Johnson & Johnson, looking to catapult itself into the global vaccine market, is in talks to pay $2.3 billion to buy Dutch biotech Crucell. Get the full story »

FDA panel rejects diet drug lorcaserin

An advisory panel to the Food and Drug Administration voted against recommending an experimental diet drug known as lorcaserin be approved for marketing.

In a first of several votes to be taken this afternoon, only five members of the panel voted that the drug’s potential benefits to overweight Americans outweigh risks. Nine voted against the drug’s benefits-to-risks ratio. Get the full story »

Half of FDA panel wants Meridia withdrawn

In a rebuke of the safety of Abbott Laboratories diet drug Meridia, eight of 16 members of a U.S. Food and Drug Administration advisory panel said this afternoon that the drug should be withdrawn from the U.S. market.

Meanwhile, six of the panelists said the drug should only be prescribed by “specially trained physicians” and include a strict FDA black box warning noting the new limits.

The other two panelists also said a new boxed warning should be added to alert consumers of increased risks of heart attacks and closer monitoring of patients by clinicians. Get the full story »

FDA panel to make call on Meridia today

A Food and Drug Administration advisory panel will decide Wednesday whether the diet drug Meridia will remain on the market amid calls that it be removed. And on Thursday, another drug, known as lorcaserin, is up before an advisory committee where its developer will face questions from panelists and a possible recommendation for agency approval.

FDA may pull Abbott’s diet pill Meridia

Almost a year after studies showed the diet pill Meridia increases heart attack and stroke risk, U.S. health regulators announced they will consider pulling the Abbott Laboratories’ drug off the market.

Meridia has been sold since 1997, but data released in November showed patients with heart disease taking the drug had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those taking a placebo. European regulators pulled the product off the market in January.