Shares of Furiex Pharmaceuticals have surged 64 percent since the Morrisville company's Japanese partner won U.S. approval for a trio of diabetes drugs Friday.

Furiex shares were trading at $34.94 a share Monday afternoon, up $13.70 a share, the biggest gain since Furiex became a standalone company in 2010. The approval of Nesina, Oseni and Kazano represents the first revenue opportunity for Furiex in the U.S. market.

The 24-employee company said Friday that the U.S. Food and Drug Administration approved three treatments for type 2 diabetes for Takeda Pharmaceutical Co. Under its agreement with Takeda, Furiex is entitled to receive a $25 million milestone payment as a result of the FDA approval as well as royalties on U.S. sales of the drugs.

Furiex is also receiving royalty payments from Takeda for the sale of two medications in Japan.

Durham drug developer BioCryst Pharmaceuticals said Tuesday that it is withdrawing what had been touted as a promising treatment for Hepatitis C in response to concerns about the drug's "toxicity profile."

BioCryst released the news after the close of market trading and said it would hold a teleconference at 8:30 a.m. Wednesday to discuss the situation with analysts and investors.

The 22-year-old drug development company has never brought a product to market in this country but its treatments for gout and for influenza are in advanced stages of human testing.

The company was hoping to move the Hepatitis drug to human testing but halted the drug indefinitely after consultation with the U.S. Food and Drug Administration, the agency that regulates and approves medicines.

"BioCryst agrees with the FDA's cautious approach," the company said in a statement. "FDA has previously placed clinical holds on other nucleotides under development."

Pozen’s stock fell 18 percent on Thursday after the Chapel Hill company announced that federal regulators may delay approval of its experimental cardiovascular drug PA32540.

The company said Wednesday that federal regulators have preliminarily decided the drug did not meet an approval milestone and have recommended further study. Pozen is seeking approval to market the drug as a replacement for aspirin in the prevention of heart disease and stroke in patients at high risk for developing ulcers from aspirin use.

PA32540, which is now in the final stages of clinical trials, is an experimental combination of aspirin and a modified version of omeprazole (Prilosec).

The FDA also told Pozen that PA32540 approval will also probably require an in vivo study of the bioequivalence of the lower-dose version of the drug, which could add money and time to the approval process.

Staff writer Gloria Lloyd

Salix Pharmaceuticals announced Monday that federal regulators have extended the date by which they expect to complete a review of Crofelemer, a potential drug treatment for HIV-associated diarrhea.

The Raleigh company said the review date has been extended from June 5 to Sept. 5. The Federal Drug Administration did not request additional studies.

The FDA granted Crofelemer priority review status in February. Such reviews are granted to drugs that offer major advances in treatment or which provide treatment where no adequate therapy exists.

Crofelemer's 125 mg tablets would treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy. Salix estimates that some 150,000 patients on the therapy experience chronic diarrhea, which can cause weight loss and complicate treatment.

A second Salix drug, Relistor, also had its FDA review date pushed back last week. Relistor treats constipation in patients taking pain medicines.

Cetero Research, a Cary-based contract research organization, announced Tuesday that it has reached a final resolution with the Food and Drug Administration over studies the company conducted between 2005 and 2010.

Last July, the FDA notified Cetero that it had uncovered “objectionable conditions” at a company lab in Houston, including falsification of dates and times, manipulation of data and other deficiencies.

On Tuesday, Cetero said that the agency would accept studies for submission and review without reanalysis or audit that were performed between Sept. 1, 2009 and

June 15, 2010. Studies performed between March 1, 2008 and Aug. 31, 2009 would need a third-party integrity audit. Studies performed between April 1, 2005 and

Feb. 28, 2008 that were previously submitted as part of an approved or pending application, or studies that will be submitted as part of a new application, will need complete reanalysis or a repeat of the study.

BioDelivery Sciences International announced today that it has signed a license and development agreement with Endo Pharmaceuticals for its experimental treatment for chronic pain.

The $180 million deal includes a $30 million upfront payment to Raleigh-based BioDelivery as well as $95 million in potential development milestone payments and $55 million in potential payments if the treatment reaches certain sales targets.

BioDelivery's stock more than doubled in early trading today on the news.

The deal represents a remarkable reversal of fortunes for the drug, BEMA Buprenorphine.

In September, BioDelivery's stock plummeted after it announced that the drug failed to outperform a placebo in a Phase 3 clinical trial.

The company subsequently launched a new study of the effectiveness of the drug based on some positive data collected in the latest trial.
 

Cornerstone Therapeutics, a specialty pharma in Cary, has acquired a small Philadelphia pharma that recently filed a new drug application with the FDA.

Cornerstone will acquire all outstanding shares of Cardiokine but financial terms of the deal were not disclosed.

Under CEO Craig Collard, Cornerstone has focused on acquiring and developing drugs used by hospitals. Cardiokine, which develops cardiovascular products for hospitals, fits in with that strategy.

Salix Pharmaceuticals announced today that a Food and Drug Administration advisory panel supports the proposed design of a clinical trial to evaluate the effectiveness of the company's drug Xifaxan in treating irritable bowel syndrome.

Salix expects to begin patient enrollment for the trial in the first quarter of next year. The company estimates it could take 24 months to complete the trial and file a resubmission with the FDA.

Trading in Salix shares was halted today in advance of the FDA ruling.
 

The Food and Drug Administration has raised several unexpected concerns in its review of Salix Pharmaceuticals application to get its best-selling drug Xifaxan approved for the treatment of irritable bowel syndrome.

Salix officials are meeting today with an advisory committee of experts that has reviewed the data the company included in its application.

The FDA identified a number of issues that had not previously been mentioned by Salix officials, said Jefferies & Company analyst Corey Davis in a research note released today.

Among the surprises were questioning whether Salix used the proper dose and proper patient population in its testing.

"We think the market is going to find these surprising given the magnitude of the agency's skepticism," Davis wrote.
 

Among the investors who is high on Salix Pharmaceuticals, the Raleigh company that specializes in gastrointestinal drugs, is hedge fund manager John Paulson.

Paulson, who made billions during the economic crisis by shorting mortgage-backed securities, now owns 1.5 million shares in the company as of June 30, according to regulatory filings.

That's an increase of 1.36 million shares over what his firm, Paulson & Co., reported at the end of the first quarter.

Paulson now owns 2.57 percent of Salix's outstanding shares, making his fund the ninth largest shareholder in the company.