Archive for the ‘Drug Development’

Banner Announces Submission of Its First-to-File ANDA for Targretin®

October 11, 2011 By: NCTechNews Category: Drug Development

(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…)

Mustard Tree Instruments® Announces Staffing Promotions, Webinar Availability

September 30, 2011 By: David D. Menzies Category: Drug Development, Drug Safety, Pharmaceuticals

(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…)

Pharmaceutical Market Access Budgets Rise in 2012 to Meet Payer Demand for Outcomes

September 29, 2011 By: NCTechNews Category: Drug Development, Research

(Research Triangle Park, N.C.) New research shows that virtually all drug research companies are planning to maintain or increase spending for market access activities in 2012. Budgeting may be fine-tuned and reallocated, but companies are cutting very little, if any, resources for these activities, the benchmarking study by Cutting Edge Information shows. In fact, most market access categories will see increased funding at more than 50 percent of drug companies next year. (more…)

Mustard Tree Instruments Releases Software Platform Upgrade for VTT 1000 Multi-Variant Testing Device

September 21, 2011 By: David D. Menzies Category: Analytics, Drug Development, Drug Safety, Pharmaceuticals

(Research Triangle Park, N.C.) Mustard Tree Instruments®, a leader in analytical instrumentation for the pharmaceutical manufacturing industry, has released an upgrade to the software platform for its unique multi-variant testing device, the VTT 1000. The release comes as the two-year-old company relocates into larger offices in the technology-rich Research Triangle Park region of North Carolina. Mustard Tree Instruments® increased its footprint from 5,400 to 14,000 square feet of offices and R&D space with the move to accommodate projected growth and future product needs. (more…)

ClinPharm Consulting Announces Reorganization of Executive Leadership

August 31, 2011 By: David D. Menzies Category: Clinical Pharmacology, Drug Development, Pharmaceuticals

(Research Triangle Park, N.C.) ClinPharm Consulting, a specialized consulting firm offering a unique paradigm for empowering drug development pipelines, announced two major staffing changes to further integrate its scientifically sound PK-PD services with new approaches to reduce risk to drug development programs and maximize return on R&D investment. Chief Scientific Officer M. Alexander Shaw, Ph.D., has been promoted to Chief Operating Officer, while Bill Wargin, Ph.D., has taken over as the firm’s new Chief Scientific Officer. (more…)

Furiex Pharmaceuticals to Present at the Wedbush 2011 Life Sciences Management Access Conference

August 15, 2011 By: NCTechNews Category: Drug Development

(Morrisville, N.C.) Furiex Pharmaceuticals, Inc. (Nasdaq: FURX), a drug development collaboration company, announced that June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, is scheduled to present at the Wedbush 2011 Life Sciences Management Access Conference on Wednesday, August 17, 2011, at 1:50 p.m. ET at the Le Parker Meridien Hotel in New York, N.Y. Dr. Almenoff will provide a corporate overview and discuss Furiex’s therapeutic pipeline. (more…)

PharPoint Research Expands in Research Triangle Park Area

July 26, 2011 By: NCTechNews Category: Biotechnology, Drug Development, Pharmaceuticals

(Chapel Hill, 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 it is expanding and has relocated their Chapel Hill, NC operations to new office space on Miami Boulevard in Durham, NC in the heart of the Research Triangle Park. (more…)

Innovative Partnership Advances Novel Drug Candidate to Combat Sleeping Sickness

June 29, 2011 By: NCTechNews Category: Drug Development, Health Care

(Washington, D.C.) The Drugs for Neglected Diseases initiative (DNDi), Anacor Pharmaceuticals, and Research Triangle Park, N.C.-based SCYNEXIS Inc. announced the successful completion of pre-clinical studies for the first new oral drug candidate discovered specifically to combat human African trypanosomiasis (HAT), also known as sleeping sickness. An article released today in the open-access journal PLoS Neglected Tropical Diseases, reveals the initial successful results of pre-clinical studies of the new compound, which will soon advance to Phase I human clinical trials. (more…)

BioPontis Alliance Enters Translational-Technology Development Agreement with Pfizer

June 28, 2011 By: NCTechNews Category: Drug Development, Finance

(Raleigh, N.C.) BioPontis Alliance, LLC announced today that it has entered into a Translational-Technology Development agreement with Pfizer, Inc. The agreement is an element of BioPontis’ unique business model, which combines translational drug research with its own asset-based investment fund. Pfizer is the second leading pharmaceutical company to join the alliance structure at BioPontis, which is a first-in-kind vehicle for capturing innovative science from academia and doing the necessary work to potentially translate discoveries into drug candidates for further development by pharmaceutical companies such as Pfizer. (more…)

Trana Discovery Announces Availability of Staphylococcus aureus Drug Discovery Assay

June 27, 2011 By: NCTechNews Category: Drug Development

(Cary, N.C.) Trana Discovery, Inc., a drug discovery technology company, today announced the availability of a new High-Throughput Screening (HTS) assay capable of selectively identifying compounds that inhibit the reproduction of Staphylococcus aureus bacteria through a unique mechanism of action: the inhibition of the bacteria’s ability to use a specific transfer RNA (tRNA) in protein synthesis. The assay opens the door for the discovery and development of critically-needed treatments of Staphylococcus aureus infections. (more…)

NCTechNews Blogging Live at BIO International Convention June 27-30

June 01, 2011 By: David D. Menzies Category: Biochemical Profiling, Biofuels, Biomarkers, Biopharmaceutical, Biotechnology, Clinical Pharmacology, Clinical Research Organization, Clinical Trials, Contract Research Organization, Drug Development, Drug Safety, Events, Government, Health Care, Innovation, Intellectual Property, Life Sciences, Medical Technology, Medicine, Nonprofit, Pharmaceuticals, Research, Tech Transfer

(Research Triangle Park, N.C.) NCTechNews, North Carolina’s technology news source, will be blogging live from the BIO International Convention in Washington, D.C. June 27-30 to cover major trends affecting the life sciences community. The BIO International Convention is the largest global event of its kind, attracting the biggest names in biotech and featuring keynotes and sessions from key policymakers, scientists, CEOs, and celebrities, and the world’s largest biotechnology exhibition - the BIO Exhibition. (more…)

Furiex Acquires Full Exclusive License Rights to Develop and Commercialize JNJ-Q2

April 20, 2011 By: NCTechNews Category: Drug Development, Pharmaceuticals

(Morrisville, N.C.) Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) announced today that it has acquired full exclusive license rights to develop and commercialize the compound JNJ-Q2 under its existing development and license agreement with Janssen Pharmaceutica N.V. (Janssen). Furiex acquired these rights as a result of Janssen’s decision not to exercise its option under the agreement that gave Janssen the opportunity to continue development of JNJ-Q2. JNJ-Q2 is a novel broad-spectrum fluoroquinolone antibiotic. Furiex has completed a successful Phase II study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is currently conducting a Phase II study in patients with community acquired bacterial pneumonia (CABP). (more…)

  • Controlling Quality

    An RTP firm is gaining international notoriety as a leader in analytical instrumentation for the pharmaceutical and chemical manufacturing industries, sharing innovative solutions to evolving pharmaceutical and chemical manufacturing challenges, presenting on emerging multi-variant approaches to obtaining immediate, unambiguous results from drug product samples at a recent major international tradeshow.

    Portable Power

    Alternative energy solutions provider INI Power Systems, Inc. recently marked its ten-year anniversary by unveiling the innovative new Trinity™ series of portable alternative energy hybrid solutions at two major events catering to the defense and emergency first responder marketplaces, with attendees searching for reliable, flexible power systems with multiple applications.

    EV Innovation

    Morrisville-based green transportation pioneer Evatran™ recently hosted a demonstration of its Plugless Power™ hands-free electric vehicle (EV) charging system, showcasing cost savings and convenience of EV usage in residential, commercial and public applications.

    guide to success

    Entrepreneurs now have a workbook to guide them through successful implementation of business building blocks thanks to a new goal-setting toolkit for personal and professional success available at no charge from a Cary-based international strategic business consultant.

    Packaging Cures

    RTP-based advertising and branding firm The Marketing Machine helped overcome the issue of illiteracy among medical patients in Ghana, South Africa in designing packaging for the only manufacturer of anti-retroviral drugs in the region, creating individual icons and colors to help patients understand which drugs they needed, regardless of their ability to read.

    Broadband Stimulus

    Two grants funded by the American Recovery and Reinvestment Act are being used by MCNC to expand broadband connectivity and services throughout North Carolina and create more than 1,000 engineering and construction jobs, the organization said.

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