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FDA reviewing study of GSK's Avandia

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.

GSK to supply vaccine to developing countries

GlaxoSmithKline has joined a global effort to vaccinate children in the world's poorest countries against pneumonia.

The pharmaceutical company, which employs about 5,000 in the Triangle, said it would supply 300 doses of its Synflorix vaccine over a 10-year-period at a steep discount. The drugs have a U.S. value of $1.3 billion but will be discounted by about 90 percent, according to the company.

The New York Times is reporting that the first 20 percent of the vaccines will cost $7 a dose and then drop to $3.50 a dose.

The deal was announced Tuesday by the GAVI Alliance, a nonprofit organization. According to the organization, pneumococcal disesases such as pneumonia and meningitis are the leading cause of death in children under age 5 in developing countries.

The deal was made possible by financing from GAVI, five donor countries (the United Kingdom, Canada, Russia, Norway and Italy) and the Bill and Melinda Gates Foundation.

Jean Stephenne, president of GSK Biologicals, said the first doses are expected to be available in Africa later this year.

Sales of GSK's Avandia suspended in Saudi Arabia

Avandia, the GlaxoSmithKline drug that is being scrutinized by U.S. regulators for possible links to heart attacks, is now under attack in Saudi Arabia.

The Saudi Food and Drug Authority has suspended sales of Avandia for six months, Bloomberg News is reporting. The agency is giving the drug maker that much time to show why the drug shouldn't be banned in the country.

Avandia's safety has been questioned in recent years as it has been linked to heart attacks and other cardiovascular problems. Some U.S. lawmakers and physicians have asked the U.S. Food and Drug Administration to review the drug's safety and pull it from the market.

GSK, which employs about 5,000 people in the Triangle, has replied to critics by saying that clinical data proves Avandia is safe and effective.

The drug's sales have been declining since 2007, when its link to heart problems surfaced.  Still, GSK realized $1.2 billion in worldwide sales of Avandia last year.

The FDA announced earlier this year that its advisory committee would meet in July to consider Avandia's safety.

Pozen reports weaker results

A Chapel Hill drug company that has already won regulatory approval for a migraine medicine expects to learn by the end of April whether its experimental arthritis drug will pass muster.

Pozen officials are awaiting word from the Food and Drug Administration on Vimovo, an arthritis drug it will market with partner AstraZeneca. The companies expect an FDA decision by April 30.

Winning approval would trigger a $20 million payment to Pozen from AstraZeneca. It also would make Pozen one of the few small drug companies based in the Triangle to have multiple products approved for patient use.

"At Pozen, we are doing what is commonly referred to in some circles as watchful waiting," said CEO John Plachetka, on a conference call with Wall Street analysts to discuss the company's fourth-quarter results.

GSK defends Avandia as criticism increases

A scathing Senate committee report on the safety of the diabetes drug Avandia contains errors, misleading conclusions and incomplete information, GlaxoSmithKline wrote in its official response, which the company posted online this morning.

"GSK stands behind the safety of Avandia," the drug maker wrote in the response. "The company rejects any allegations of concealing safety information or acting inappropriately on behalf of patients."

The Senate report is just the latest salvo from critics who say the drug, which was approved in 1999, can cause heart attacks or other health problems. Some lawmakers and physicians are calling for the Food and Drug Administration to review its safety and pull it off the market.

GSK said it welcomes a "fair examination of the company's record" and the clinical data that proves Avandia is safe and effective.

GSK to cut more jobs, reduce research spending

GlaxoSmithKline plans to eliminate an undisclosed number of employees as the drug maker expands its efforts to reduce costs.

The latest job cuts follow thousands of layoffs worldwide during the past two years and again will likely hurt GSK's Triangle workforce and the local economy. CEO Andrew Witty is slashing expenses to offset slowing sales of blockbuster drugs.

GSK announced this morning that it plans to expand previous cost-cutting efforts to save nearly $800 million more a year by 2012. The move will reduce research and development spending, which will effect its R&D hubs, including in Research Triangle Park.

"Where possible, we will continue to try to preserve jobs," Witty said in a prepared statement. "As before, we will not be providing targets for job reductions and we will announce restructuring outcomes once employees" and unions are notified.

As part of the shift, GSK will stop research into new drugs for depression and pain, he said.

GSK to announce more job cuts, report says

Drug maker GlaxoSmithKline, which has cut hundreds of Triangle jobs in recent years, will announce another round of layoffs Thursday when it reports quarterly earnings, a British newspaper reports.

The London-based corporation employs about 5,000 people in this region, mostly at its North American headquarters in Research Triangle Park. GSK has been slashing expenses under CEO Andrew Witty to offset slowing sales of blockbuster drugs amid increasing competition from cheaper, generic medicines.

Now the company is preparing to announce plans to eliminate 4,000 jobs, nearly half at its research centers, the Sunday Times of London reports. GSK "will scale down activities at research facilities in Britain, across Europe and in the United States as it builds its activities in emerging markets," the newspaper reports.

GSK's ongoing layoffs could hurt the Triangle's economy, as more highly paid researchers and scientists are thrown out of work. The company employs about 100,000 worldwide.

GlaxoSmithKline donates $1.5 million to Morehead Planetarium

GlaxoSmithKline is getting its name in the stars.

The pharmaceutical company gave $1.5 million to help convert the Star Theater at the Morehead Planetarium in Chapel Hill to digital from analog technology.

The theater will be renamed the GlaxoSmithKline Fulldome Theater, officials announced today.

GSK has supported programs at Morehead for years. The British company has its North American headquarters in Research Triangle Park and employs about 5,000 people in the Triangle.

The company "is committed to making positive contributions to the communities where employees live and work and to invest in health and education programs," GSK senior vice president Janice Whitaker said in a prepared statement.

Such donations also help corporations build their brand names.

The theater is closed during January for the conversion and is scheduled to reopen Feb. 5. Morehead officials expect more than 160,000 visitors, including 85,000 schoolchildren, during the next year.

GSK shares fell as Europe cuts flu-shot orders

Weakening demand for H1N1 flu vaccines in Europe is cooling interest in GlaxoSmithKline's stock.

Shares of the British drug maker have fallen this week as Germany, France cut orders for GSK's vaccine.  The U.K. and Belgium also are considering reducing orders, fueling worries about overcapacity, Bloomberg News reported.

"We are in discussions now with GSK about the vaccine coming in and are under discussions about the surplus we already have," said David Salisbury, director of immunization for the U.S. Department of Health. GSK has delivered about 23.9 million doses to the U.K., he added.

GSK has paid $1 billion in Paxil suits, Bloomberg reports

GlaxoSmithKline has paid nearly $1 billion to resolve lawsuits over Paxil since it began selling the antidepressant in 1993, Bloomberg News reported, citing court records and people familiar with the cases.

The total included about $390 million for suicides or attempted suicides said to be linked to the drug, Bloomberg reported.

GSK, the British drugmaker with a North American headquarters in Research Triangle Park, hasn't disclosed a settlement total. Spokeswoman Sarah Alspach declined to confirm the $1 billion figure.

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