GlaxoSmithKline is having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia, the Wall Street Journal reports this morning.

The drug has been linked to an increased risk of heart attack, but GSK officials have said it's a safe and effective product. Federal regulators are considering whether to halt the so-called TIDE clinical trial early because of Avandia's health risks.

Two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study, GSK reports. The British company, which has its North American headquarters in Research Triangle Park, didn't name the second site.

GlaxoSmithKline has reportedly agreed to pay about $60 million to settle 700 lawsuits alleging that its Avandia diabetes drug causes heart attacks and other health problems.

Bloomberg News reported the settlements today, citing unnamed sources.

Officials with the British drugmaker, which has its North American headquarters in Research Triangle Park, declined to comment on possible settlements.

“GlaxoSmithKline stands by Avandia and is fully prepared to defend any litigation,” spokeswoman Bernadette King said in an e-mailed statement.

GSK faces about 4,000 lawsuits so far over the drug, and is preparing for the first trial, in state court in Philadelphia, in July.

As officials with Pozen await word from regulators on its experimental arthritis drug, the Chapel Hill company reported a $3 million net loss for the first quarter.

The Food and Drug Administration is expected to rule as soon as Friday on Pozen's Vimovo. If the medicine wins approval, it would give Pozen a second approved product, a milestone that would put in rare company among the Triangle's small pharmaceutical firms.

Winning FDA approval also will trigger a $20 million payment from Pozen's partner AstraZeneca.

This morning, Pozen reported that revenue fell to $6.9 million during the quarter that ended March 31, down 22 percent from a year earlier. The net loss of 10 cents a share, however, was an improvement from a 12-cent loss a year earlier.

Pozen received $3.8 million in royalty revenue from sales of its migraine drug Treximet during the quarter. That pill is marketed by Pozen's partner GlaxoSmithKline.

Pozen shares fell 17 cents Wednesday to close at $10.95. The stock is up 83 percent so far this year.

Federal regulators are reviewing whether to stop a safety study of GlaxoSmithKline's controversial diabetes drug Avandia, which some critics say should be pulled off the market.

Studies have tied the medicine to an increased risk of heart attacks, but GSK says that the drug is safe and effective.

Now the Food and Drug Administration is reassessing an ongoing study comparing Avandia with a rival medicine, and whether it's ethical to continue the research amid mounting health concerns, FDA commissioner Margaret Hamburg wrote in a letter dated March 30.

The Wall Street Journal first reported on Hamburg's letter, saying that a decision to halt the trial also may determine whether the FDA asks GSK to pull the drug off the market.

Federal regulators found problems during recent inspections of Hospira's massive drug and medical device factories in Clayton and Rocky Mount.

The company has recalled two injectable products made in Clayton because of an equipment failure at the facility contaminated an anesthetic agent called Propofol and an intravenous nutritional product called Liposyn, Bloomberg News reported. The products are sold to hospitals and physicians.

The company received a warning letter from the U.S. Food and Drug Administration dated April 12 outlining "deficiencies related to particulate in certain emulsion products" at the Clayton facility, Hospira reported in a regulatory filing today. The letter also discusses problems with manufacturing validation processes and quality control procedures.

The FDA letter does not restrict production or shipment of products made at the two plants, but Hospira is holding shipment of certain products pending its own investigation and discussions with the FDA, the company reported in a filing with the Securities and Exchange Commission.

"We are continuing to manufacture products at these plants," said Hospira spokesman Dan Rosenberg. "We take very seriously these comments from the FDA. We're in the process of implementing the necessary improvements and we'll work closely with the agency to ensure we meet all its expectations as soon as possible."

Shares of Salix Pharmaceuticals rose five percent today as investors hailed Wednesday's announcement that the FDA has approved the Morrisville company's application to market its best-selling Xifaxan for serious liver disease.

Salix shares closed at $35.29 today, up $1.77. Shares rose as high as $38 earlier in the day.

Analysts at Roth Capital Partners put a 12-month price target on the stock at $43 per share.

Roth's report said estimates of Xifaxan sales in 2010 being between $160 and $170 million appear low.

Roth's report said a conservative estimate of the drug's revenue target is $181 million.

GlaxoSmithKline has won approval from U.S. regulators to sell its vaccine to fight H1N1, making it the last major drug manufacturer to receive clearance in this country.

The British company with its North American headquarters in Research Triangle Park also said that the U.S. Health Department has ordered 7.6 million doses of the swine flu shot.

GSK will make the vaccine at its factory in Quebec. The company expects to begin shipping the U.S. doses in December and provide all of them by the end of the year.

In September, the U.S. Food and Drug Administration approved vaccines made by four of the five companies expected to manufacture swine flu vaccines. At that time, GSK officials said they expected to win approval "as soon as possible."

GSK was left out because of challenges making a vaccine without an adjuvant, an ingredient added to boost potency so more people can be treated, Bloomberg News reported.

U.S. vaccine supplies have been held up by production snags at two drugmakers and GSK's delays in winning approval, Bloomberg reported.

Farmers from across the state met in Raleigh this morning to express their concerns about potential food safety legislation that could change the way they are allowed to operate.

In a meeting at the State Fairgrounds in Raleigh, a panel of farmers addressed representatives from the U.S. Department of Agriculture and the Food and Drug Administration. State agriculture department officials were also there, along with a group of about 60 other industry officials, farmers and consumers.

At the top of the list for many farmers in attendance: a fear that sweeping legislation would make it difficult for small farmers to continue to operate, either because complying would cost too much money or take too much time.

"You should not prevent new farmers from wanting to enter the market," said John Vollmer, whose family operates the Vollmer Farm in Franklin County. "When Farmer John croaks, who's going to take it on? I hope [complying with the new rules] won't be such a mountain that my son and daughter-in-law won't want to take it on."

Chapel Hill drug maker Pozen announced this morning that the Food and Drug Administration has accepted its application to market an experimental treatment for arthritis.

The FDA move signals that the drug, called Vimovo, could win regulatory approval by March, if it doesn't run into snags. The drug would be Pozen's second approved product, with the migraine drug Treximet.

News of the FDA acceptance of Vimovo's application also triggers a $10 million milestone payment to Pozen from partner AstraZeneca, which has licensed the marketing rights to the drug.

Pozen's shares rose 26 cents to close at $6.73 today.

Chapel Hill drug maker Pozen swung to a loss in the second quarter, as royalties from its migraine drug didn't do much to boost profit.

During the quarter, Pozen earned $900,000 in royalties on the drug, Treximet, which is sold by partner GlaxoSmithKline. Analysts are worried that insurers' reluctance to cover Treximet's high price is hurting sales.