Federal regulators, which were scheduled to issue a decision on a new drug to treat lupus next week, have delayed their decision until March.

The drug, known as Benlysta, would be the first new treatment for the autoimmune disease in more than 50 years. It also would provide a needed boost for its developers, Human Genome Sciences and GlaxoSmithKline.

But that boost will be delayed, in a disappointment for the companies and investors.

The Food and Drug Administration has pushed back its review of the drug until March 10, the companies announced this afternoon. The FDA was scheduled to rule on Dec. 9, but requested more information on the drug.

The first new treatment for lupus in more than 50 years won the blessing of a federal regulatory panel today, providing good news for patients and the drug's developers.

The U.S. Food and Drug Administration panel voted 13-2 that the drug, known as Benlysta, is safe and effective. Benlysta works well enough to outweigh risks of suicide, infection and cancer, and should be approved, the panel recommended.

The full FDA is scheduled to decide on the drug next month, and usually follows the recommendation of its advisory panels.

Analysts say the drug is likely to be approved because it addresses an unmet medical need, and some expect annual sales to exceed $2 billion eventually.

The drug to treat the incurable autoimmune disease would provide an important new revenue source for its developers, GlaxoSmithKline and Human Genome Sciences. 

Japanese drug maker Eisai won regulatory approval today for its new treatment for late-stage breast cancer.

The drug, known as Halaven, is a synthetic form of a compound found in sea sponges that works by inhibiting cancer cell growth, the Food and Drug Administration wrote in a prepared statement.

While the drug is made outside the U.S., Eisai will label and package it for the U.S. market at a $100 million, 65,000 square-foot facility that opened in May on its Research Triangle Park campus. The company has its U.S. headquarters in New Jersey, but employs about 325 people at its main manufacturing campus in RTP.

The injectable drug, also known as eribulin mesylate, will be the first oncology product packaged at the new facility. Eisai officials have said they may add more jobs in RTP as its cancer program expands.

A Durham attorney who once worked in GlaxoSmithKline's legal department has been charged with obstructing an official proceeding, concealing and falsifying documents and five counts of making false statements to the Food and Drug Administration.

Lauren Stevens was indicted this week by the U.S. Justice Department for impeding an FDA inquiry in 2002.

The indictment doesn't name the company Stevens worked for other than to say it was a major pharmaceutical company. The company has not been charged with a crime.

Mary Anne Rhyne, a GSK spokesperson, confirmed that Stevens worked in the company's U.S. legal department and is now retired.

London-based GSK has its U.S. headquarters in Research Triangle Park.

In an e-mail , Stevens attorney, Brien T. O'Connor, said his client is innocent of the charges.

The indictment states that in October 2002 the FDA asked for information about the company’s promotion of a prescription drug as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the agency, also known as "off-label" uses.

The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison.

Pozen reported weaker results and warned that it won't start key clinical trials of a new drug this year as expected.

The Chapel Hill company's net loss of $8.6 million during the third quarter was slightly worse than analysts had anticipated. Revenue, which includes royalties on sales of its Treximet migraine drug and Vimovo arthritis pain medicine, fell to $4.3 million.

Salix Pharmaceuticals announced this morning that federal regulators need more time to review its request to market an existing drug as a new treatment for irritable bowel syndrome.

The news is a minor setback for the Morrisville drug company, which has projected that winning approval to treat IBS could mean billions of dollars in additional annual sales for the drug, known as Xifaxan.

Salix shares fell 69 cents in morning trading to $37.72. The stock is down about 12 percent in the past week.

The Food and Drug Administration had granted Salix's application priority review, and expected to make a decision by Dec. 7. But the FDA extended that deadline by three months to March 7.

A new iPhone app developed by researchers at UNC-Chapel Hill and Children's Hospital of Boston lets doctors and patients track the latest drug safety information about their prescription medicines.

The application, called MedWatcher, tracks official alerts from the Food and Drug Administration and related news from various media. Patients and doctors can also use the app to report side effects and view reports of problems that others submit. Those reports will be reviewed by members of the epidemiology group at Children's Hospital Boston and then submitted to the FDA.

A federal regulatory panel today agreed that GlaxoSmithKline's controversial diabetes drug Avandia increases the risk of heart attacks and other cardiovascular problems.

But the panel also said that Avandia doesn't increase the risk of death compared with other treatments for the disease, Bloomberg News reported.

The advisers are considering in a series of votes whether available Avandia research is sufficient to determine the risk of the drug approved in 1999.

The panel is expected to recommend later today whether Avandia should be pulled from the market, slapped with stronger warnings or left alone. The FDA typically follows its panels' recommendations, but doesn't have to.

GSK officials say the drug is safe. The company wants to avoid the financial hit, legal hassle and PR headache that would come from withdrawing the drug.

A Food and Drug Administration commissioner said today that regulators considering a recall of GlaxoSmithKline's diabetes pill Avandia should "keep an open mind," Bloomberg News reports.

Margaret Hamburg made her comments during the first day of a two-day FDA advisory panel meeting on Avandia being held in suburban Washington.

"Follow the science, wherever it leads, and the rest will fall into place," Hamburg said.

Bloomberg also reported today that GSK has agreed to pay $450 million to settle a majority of the lawsuits, about 10,000, alleging Avandia can cause heart attacks and strokes.

At the conclusion of the two-day hearing, the panel is expected to recommend to the FDA whether the drug should be pulled or whether new warnings or restrictions are warranted because of safety concerns.

As Merck officials await regulatory approval to begin commercial production at a new vaccine plant in Durham, the company is cutting back other places.

Merck announced this morning that it plans to close eight research labs and eight manufacturing plants worldwide, as part of a broader cost-cutting effort following its acquisition of rival Schering-Plough last year.

The restructuring also is tied to a plan to eliminate about 15,000 jobs, or 15 percent of Merck's workforce.

Meanwhile, Merck expects to receive word this month from the Food and Drug Administration to begin selling vaccines made at its Durham facility. Two more phases of expansion at the plant are expected to be ready in 2012.