(Morrisville, N.C.) Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced that the European Commission endorsed the positive opinion adopted by the Committee for Human Medicinal Products (CHMP) on October 18, 2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending national approvals, the marketing authorization for the Priligy doses can be granted in the European Union Member States where the drug has not yet been approved, and also in Norway and Iceland. The indication for Priligy approved by the EC is the on-demand treatment of premature ejaculation in men between the ages of 18 and 64. (more…)

(Research Triangle Park, N.C.) Mustard Tree Instruments®, the leader in analytical instrumentation for the pharmaceutical manufacturing industry, has strengthened its executive team with the promotion of Peter Cregger to the position of Chief Operations Officer. Cregger will be responsible for manufacturing, engineering, software development, and project management for hardware and software products such as the VTT-1000 multi-variant testing device. (more…)

(Research Triangle Park, N.C.) Liquidia Technologies has announced it has entered into a collaborative agreement with PATH, a global health nonprofit organization, to conduct preclinical proof-of-concept studies on a next generation pneumococcal vaccine that could potentially allow for broadened efficacy and manufacturing efficiencies and result in greater access of such a vaccine to a global population. According to the World Health Organization (WHO), pneumonia kills an estimated 1.4 million children under the age of five years every year – more than any other illness. More than half of these deaths are caused by Streptococcus pneumoniae, a bacterium that has many variations globally and is becoming increasingly resistant to antibiotics. (more…)

(Hayward, Calif. & Research Triangle Park, N.C.) To speed development of a potential ground-breaking therapy for Type 2 diabetes – a debilitating and deadly disease that currently affects almost 350 million people worldwide – Intarcia Therapeutics, Inc., and Quintiles today announced the signing of definitive agreements whereby Quintiles will become a financial and strategic partner for the global clinical development of Intarcia’s ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide). (more…)

(Morrisville, N.C.) Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced top-line results from the Phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin (Lipitor®). Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile. (more…)

(Research Triangle Park, N.C.) Mustard Tree Instruments®, an innovator in analytical instrumentation for the pharmaceutical manufacturing industry, is pleased to announce that Science Officer Brisco Harward Ph.D. addressed members of the NY Section of the Society for Applied Spectroscopy (NYSAS) on November 9, 2011. Dr. Harward was invited to address the group by a leading spectroscopist who was attending a demonstration of the Mustard Tree Verifier™ Tri-Test 1000 (VTT-1000) analytical testing device earlier this fall. (more…)

(Durham, N.C.) PharPoint Research, Inc., a leading drug development service provider offering biotechnology and pharmaceutical companies expertise in project management, clinical monitoring, data management and biostatistics services, announces that PharPoint Research was recognized by Triangle Business Journal as one of the 50 fastest growing companies in the Triangle area. The Fast 50 winners were selected and ranked based on a formula that counts revenue growth and profitability in the preceding three years (2008-2010). Art Holmes, the company’s President and CEO, commented, “This award is a testament to our company’s commitment to superb quality and client satisfaction. By focusing on these two areas, in the past 12 months we have been able to grow the company’s size by over 45% to offer even more services to better serve our clients.” (more…)

(Research Triangle Park, N.C.) Todd Blonshine, CEO of Mustard Tree Instruments® addressed an audience of over 75 members of the pharmaceutical, life sciences, and affiliated market sectors in the Research Triangle Park region as the featured speaker for November’s Innovation in RTP event. In his presentation, “Drug Shortages and Recalls: Redefining Quality Control in the Pharmaceutical Manufacturing Industry with A Purpose” Blonshine discussed the challenges of quality control issues with raw materials in the drug manufacturing process and how his company is helping to alleviate the strain on manufacturers through its innovations in analytical testing instrumentation. (more…)

(Research Triangle Park, N.C.) Drug discovery company SCYNEXIS, Inc. today presented data demonstrating that SCY-635—a novel, oral cyclophilin inhibitor being studied for the treatment of hepatitis C virus (HCV) infection—reactivates the body’s natural defense mechanism, making it capable of inhibiting replication of the virus. The data positions SCY-635 as a potential replacement for recombinant interferon—a component of the standard of care for hepatitis C treatment that is associated with significant side effects. The data were presented in a poster session at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. SCY-635 is currently undergoing Phase 2 studies. (more…)

(Wilmington, Del. & Winston-Salem, N.C.) AstraZeneca and Targacept, Inc. today announced top-line results from the first of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment. The study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo. (more…)

(High Point, N.C.) Banner Pharmacaps Inc. (“Banner”) has confirmed that its Abbreviated New Drug Application (“ANDA”) for Bexarotene 75 mg soft gelatin capsules, a generic version of Targretin, has been accepted for review by the US Food and Drug Administration (FDA). Based upon available information, Banner believes that it is the first applicant to file an ANDA for Targretin containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act, and expects to qualify for 180 days of generic marketing exclusivity upon FDA approval. (more…)

(Research Triangle Park, N.C.) Mustard Tree Instruments®, the leader in analytical instrumentation for the pharmaceutical manufacturing industry, is announcing two promotions of technical staff to bolster the company’s development of new analytical tools to redefine product testing regimen and avoid costly recalls. Brian Garrett, who joined Mustard Tree Instruments® as its Director of Analytics two years ago, has been named Chief Technical Officer.  Jared Peterson has been promoted to Software Architect and Manager where he will lead the company’s software development team. (more…)