NCBiotech News

We work hard to bring you the stories about the life science community in North Carolina. Every once in a while, we add a little news of our own. Read some of those stories below, or check out some of our perspectives on our staff blog.

Morrisville-based Kowa Research Institute (KRI), a subsidiary of Kowa Co., Ltd., one of Japan's largest privately held companies, was instrumental in this week's marketing approval from the U.S. Food and Drug Administration for Livalo (pitavastatin), a low-dose version of the cholesterol-fighting drugs known as statins.

The FDA approved the maximum 4 milligram dose for people unable to reduce their cholesterol levels through diet and exercise.

KRI was established in 1997 in California and moved to the site near Research Triangle Park in 2003.

Burlington-based Laboratory Corporation of America (LabCorp) has completed the $106 million buyout of California molecular diagnostics and testing services company Monogram Biosciences.

LabCorps' cash tender offer via its wholly owned subsidiary, Mastiff Acquisition Corp., means the South San Francisco-based Monogram will be a wholly owned subsidiary of LabCorp, and Monogram shares will no longer be traded.

Liquidia Technologies, headquartered in Research Triangle Park, has received an additional $7 million round of venture funding, bringing total capital so far for the 5-year-old University of North Carolina at Chapel Hill spin-out to $31.5 million.

Yonnie Butler, business development director at the North Carolina Biotechnology Center, is among the presenters at a free public entrepreneur support breakfast to be held Aug. 13 at the Council for Entrepreneurial Development (CED) headquarters in Durham.

Butler is one of 16 representatives of area professional organizations who will talk briefly about their organizations' missions during the kickoff of the Competitive Advantage through Fundamentals of Entrepreneurs (CAFE) workshop series, running approximately every other month through December, 2010.

Christy Shaffer, Ph.D., president and CEO of Inspire Pharmaceuticals in Durham and a former member of the North Carolina Biotechnology Center board of directors. has announced plans to step down after 11 years of Inspire leadership.

Cary-based specialty pharmaceutical company Cornerstone Therapeutics, formerly Cornerstone BioPharma, has closed a strategic transaction with Chiesi Farmaceutici, of Parma, Italy, giving Chiesi controlling ownership of the company and Cornerstone exclusive rights to market products in the United States.

A new initiative to link international companies to resources in the PIedmont Triad officially launched today.

The Center will provide assistance with business organization, intellectual property protection, regulatory counseling, market-channel development and connections to capital for international bioscience companies seeking to enter the Piedmont Triad.

The U.S. Food and Drug Administration has given Research Triangle Park-based Tranzyme Pharma a "Fast Track" designation for its oral gastrointestinal drug candidate TZP-102.

The federal agency said it would expedite its review of the experimental treatment for gastroparesis, a major complication that arises in 30 to 60 percent of people with diabetes. Symptoms include nausea, vomiting, loss of appetite and early satiety, and may affect nutrient delivery to the small intestine with resultant fluctuations in blood glucose levels, loss of weight, and malnutrition.

Organizers of the BioProcess International Conference & Exhibition have announced details of that event, which will take place at the Raleigh Convention Center from October 12-16, 2009.

The international biopharmaceutical meeting will include presentations and seminars in four tracks: manufacturing efficiency and supply chain security, scaling up from bench through commercialization, cell culture & upstream processing, and recovery & purification.

PharmAgra Labs, Inc., announced that its drug-manufacturing facility in Brevard has passed an inspection by the U.S. Food and Drug Administration. The approval clears the way for the 10-year-old contract research-and-development firm to produce pharmaceutical ingredients for use in clinical trials.

"The inspection was thorough and we are very pleased with the outcome" said Roger Frisbee, the company's co-president.

Winston-Salem-based Targacept has been awarded a grant of more than $600,000 from The Michael J. Fox Foundation for Parkinson's Research to fund preclinical studies into the potential for Targacept technology to reduce the involuntary jerking and twitching associated with the disease.

Burlington-based lab services giant LabCorp said it has passed the federally required waiting period and encountered no antitrust opposition to its purchase of California-based Monogram Biosciences.

LabCorp said in a news release that it is proceeding with its acquisition of Monogram for $4.55 a share--about $106 million.

The Raleigh-based Eastern North Carolina chapter of the National Multiple Sclerosis Society is taking award nominations through 5 p.m. Aug. 14 for North Carolina people or organizations making significant contributions to health and life sciences in the state.

The organization plans to confer three Health & Life Sciences Awards at its Dinner of Champions, an annual industry dinner and fundraiser benefiting the National MS Society, on Thursday, September 3, at The Umstead Hotel and Spa in Cary.

Winston-Salem-based Targacept has reported promising results from a Phase IIb clinical trial for an experimental augmentation therapy, or add-on, drug to treat major depressive disorder (MDD).

The drug, TC-5214 is an enantiomer, a mirror-image substance with the same chemical but potentially different biological properties, of a drug previously tested by Targacept for patients with MDD who did not respond adequately to first-line treatment. But TC-5214 has shown better overall safety and efficacy.

The pharmaceutical development division of AAIPharma has been purchased by Chicago private equity firm Water Street Healthcare Partners.

Water Street said in a statement that it has committed up to $75 million in equity financing to expand the business, which currently employs 450 scientists and professionals.