Articles By Cyndi Root

  1. Boehringer Ingelheim's Tiotropium Improves Adolescent Asthma In Phase III Trial 9/12/2014

    Boehringer Ingelheim announced in a press release a Phase III trial of tiotropium (brand name Spiriva) in adolescent asthma patients, showed statistically significant improvement in lung function. The company is presenting data from the trial program, UniTinA-asthma, at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany. Spiriva HandiHaler (tiotropium bromide inhalation powder) is Food and Drug Administration (FDA) approved for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) and for treatment of breathing problems associated with COPD.

  2. NIH's NIAAA To Conduct Clinical Trial Of Gabapentin Enacarbil For AUD 9/11/2014

    The National Institutes of Health (NIH) announced in a press release that its agency the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will conduct a six-month trial of gabapentin enacarbil (brand name Horizant) in people who have been diagnosed with alcohol use disorder (AUD). XenoPort, a biopharmaceutical company from Santa Clara, California, will supply the study drug. George F. Koob, Ph.D., director of the NIAAA, said, “Prior clinical studies of gabapentin, the active metabolite of the molecule called gabapentin enacarbil, have shown positive results in patients with AUD. We believe that the time is right to conduct a multi-site, well-controlled clinical trial.”

  3. Mayo Clinic, IBM Partner To Match Patients To Clinical Trials 9/10/2014

    The Mayo Clinic and IBM announced in a press release that they plan to use Watson, a supercomputer, to match patients to clinical trials. IBM’s Watson is a cognitive computer, which will be customized for Mayo Clinic applications. The computer will teach itself and mature over time, becoming more efficient at matching patients and locating patients for difficult trials, such as rare diseases.

  4. FDA Accepts Astellas' NDA For Isavuconazole For Invasive Aspergillosis and Invasive Mucormycosis 9/10/2014

    Astellas announced in a press release that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for isavuconazole. The intravenous and oral broad-spectrum antifungal is for the treatment of invasive aspergillosis and invasive mucormycosis. The FDA is required to act on the application by March 8, 2015. The FDA has already granted isavuconazole Qualified Infectious Disease Product (QIDP) status and Orphan Drug status for invasive aspergillosis and invasive mucormycosis, both of which are life-threatening fungal infections.

  5. U.K.'s MHRA To Build App For Adverse Event Reporting 9/9/2014

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) announced in a press release that it will be leading an initiative to develop an application (app) for adverse drug reaction (ADR) reporting. The WEB-RADR project is a three-year collaboration with MHRA, European regulators, the pharmaceutical industry, and academics. The app is intended for consumers and healthcare profession

  6. Mallinckrodt's MNK-155 Shows Promise In Phase III Acute Pain Trial 9/9/2014

    Mallinckrodt announced in a press release that a Phase III trial for MNK-155 met its primary endpoint. The oral formulation of hydrocodone and acetaminophen demonstrated improved pain scores compared to placebo in patients undergoing a bunionectomy. Mallinckrodt is presenting the data at PAINWeek 2014, a national pain conference held in Las Vegas, Nevada. The company’s New Drug Application (NDA) for MNK-155 submitted to the Food and Drug Administration (FDA) in May 2014, included data from the trial.

  7. CRO PPD Acquires Trimentum Clinical Trial Method From RCT Logic 9/8/2014

    Pharmaceutical Product Development, a contract research organization (CRO), announced in a press release that it has acquired Trimentum, sequential parallel comparison design (SPCD), from RCT Logic. The technology allows clinical trial sponsors a way to decrease the impact of the placebo effect. Recent trials in major depressive disorder (MDD) have shown the efficacy of the program, which is applicable to many disease areas.

  8. Merck's Allergopharma, S-TARget Partner To Develop S-TARget's Allergy Therapeutics 9/5/2014

    Allergopharma, Merck KGaA’s allergy division, announced in a press release that it has formed a partnership with Austrian-based S-TARget Therapeutics. The two companies signed an exclusive licensing agreement to use S-TARget’s S-TIR to develop allergy treatments. Marco Linari, CEO of Allergopharma, said, "With S-TARget's technology platform, we have great potential available to develop new therapeutic forms for the most significant allergens, such as dust mites and pollen.”

  9. Cellceutix Compares Brilacidin To Cubicin In Phase IIb Trial For ABSSSI 8/22/2014

    Cellceutix Corporation announced in a press release that it has completed enrollment for a Phase IIb trial comparing Brilacidin to Cubicin (daptomycin) for acute bacterial skin and skin structure infections (ABSSSI). In the fourth quarter of 2014, the company expects data from the trial. Brilacidin shows promise as a single-dose antibiotic with a low potential for antibiotic resistance.

  10. NIH Begins Genetic Testing Trial For Stage IB-IIIA Non-Small Cell Lung Cancer 8/21/2014

    The National Institutes of Health (NIH) announced in a press release that it has launched a genetic testing trial to identify genes in stage IB-IIIA non-small cell lung cancer (NSCLC) tumors that have been or will be removed by surgery. The ALCHEMIST study, which is being carried out at the Dana-Farber Cancer Institute in Boston, Washington University in St. Louis, and the University of Texas Southwestern Medical Center in Dallas, consists of three components – screening, EGFR treatment, and ALK treatment. The National Cancer Institute (NCI) will conduct the study.