RALEIGH, N.C.–BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the completion of its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone (BNX) in the treatment of opioid dependent patients. (more…)

MORRISVILLE, N.C.–Vestiq Pharmaceuticals, an emerging Specialty Pharmaceutical Company, formally announces its launch of products that began commercialization in December of 2012. Vestiq is strategically formed through a consolidation of existing U.S. and international pharmaceutical entities and industry partnerships. The Company’s headquarters are located near Research Triangle Park, N.C., and the company’s website is www.vestiqpharma.com. (more…)

RESEARCH TRIANGLE PARK, N.C.–Tranzyme Pharma (Nasdaq:TZYM) today announced that David S. Moore has been named as Chief Business Officer. “Dave has provided meaningful contributions and leadership since joining Tranzyme said Vipin Garg, PhD, Tranzyme’s President and Chief Executive Officer. I look forward to working with him in his new role as we continue to advance the Company.” Mr. Moore joined Tranzyme in August 2011 from Johnson & Johnson as Vice President, Commercial Operations and his responsibilities were increased in January 2012 to include the oversight of Business Development. (more…)

RALEIGH, N.C.–BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the hiring of George K. Ng as Senior Vice President & General Counsel.  In this capacity, Mr. Ng will be responsible for overseeing BDSI’s legal, compliance and intellectual property activities.  Mr. Ng will report directly to Dr. Mark A. Sirgo, President and Chief Executive Officer. Mr. Ng has more than a decade of experience in both law and the pharmaceutical and life sciences fields.  Mr. Ng has held various senior management positions with publicly-traded, global biotechnology and pharmaceutical companies, including Spectrum Pharmaceuticals, Inc. and Alpharma, Inc., with oversight over legal, intellectual property, litigation and compliance matters.  Additionally, Mr. Ng has been responsible for the legal lead in due diligence, negotiations and contract preparation for multiple business development transactions, including U.S. and ex-U.S. licenses, global collaboration agreements and intellectual property and product acquisitions. (more…)

RESEARCH TRIANGLE PARK, N.C.–Tranzyme Pharma (Nasdaq:TZYM) today announced it is discontinuing and immediately ending patient enrollment in DIGEST, a Phase 2b trial in diabetic patients receiving TZP-102 for the management of symptoms of gastroparesis, due to insufficient efficacy. The decision followed a planned interim futility analysis, which examined patients’ responsiveness to thrice daily oral dosing of 10mg of TZP-102 or placebo at the end of weeks 4 and 8 of a 12 week trial. The results are consistent with the findings of a prior Phase 2b trial in that there was a very large placebo effect and no treatment effect. (more…)

CHAPEL HILL, NC–Crown Marketing (OTCQB: CWNM) is pleased to announce that its Controlled Drug Delivery Technology (CDDT) has the potential to revolutionize the manner in which we take oral medication.  Crown’s CDDT is a novel controlled-release technology that harnesses the principles of diffusion through precise mathematical formulas. Crown believes the spectrum and reliability of pharmacokinetic profiles achievable with this technology is superior to currently marketed devices and formulations. Crown’s simple design allows for a high level of flexibility in matching chronotherapeutic requirements. Cost-efficiencies in the commercial manufacturing process, when compared to other drug delivery technologies, may constitute its most important competitive advantage. (more…)

RESEARCH TRIANGLE PARK, N.C.–BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) has announced that in response to recent events and an assessment of its assets, the Company is restructuring and implementing a focused strategy to advance its hereditary angioedema (HAE) and antiviral programs. The restructuring is intended to significantly reduce BioCryst’s cost structure and scale the organization appropriately for its current portfolio. The Company plans to direct its cash and other resources primarily to enable the achievement of important near-term milestones for the BCX4161 HAE, BCX4430 broad spectrum antiviral and BCX5191 hepatitis C (HCV) programs. (more…)

RALEIGH, N.C.–BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the 24th Annual Piper Jaffray Healthcare Conference.  The presentation is scheduled for Tuesday, November 27, 2012 at 11:50 a.m. Eastern Time, at The New York Palace in New York City. (more…)

RESEARCH TRIANGLE PARK, N.C.–Tranzyme Pharma (Nasdaq:TZYM), today announced that Vipin K. Garg, Ph.D., President and CEO, will speak at the 24th Annual Piper Jaffray Healthcare Conference taking place at the New York Palace hotel, New York, NY November 27-28, 2012. Tranzyme’s session is scheduled for Wednesday, November 28th at 12:30 pm ET. (more…)

RESEARCH TRIANGLE PARK, N.C.–Tranzyme Pharma (Nasdaq:TZYM), today announced top-line results of the preliminary analysis of the first of two Phase 2b trials assessing the safety and efficacy of its oral ghrelin agonist, TZP-102 in diabetic patients with gastroparesis. The results, which evaluated patients who were given a single daily dose of 10 mg of TZP-102, 20 mg of TZP-102 or placebo for 12 weeks indicate the trial did not meet its primary efficacy endpoint. (more…)

(Pittsburgh, Pa. & Research Triangle Park, N.C.) Bayer Corporation today announced that it is providing monetary support for disaster relief efforts through donations totaling $150,000 from the Bayer USA Foundation. The American Red Cross and Save the Children will each receive $75,000. The northeastern coast of the United States continues to be affected by Hurricane Sandy, which caused extensive damage to cities and rural communities, leaving millions of people without power or homeless. “When millions of people are affected by devastation in the form of natural disasters, it is important to be able to provide assistance to families and communities in a time of great need,” said Tracy Spagnol, chairperson, Bayer USA Foundation. (more…)

CARY, NC–Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, announced today that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. (more…)