The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
Aeras, not-for-profit enterprise, is the only player solely organized around a TB vaccine goal with integrated development and manufacturing in a single organization.
As a new technological space containing all the alternatives, the most practical and immediate application for Rapid Mobile Diagnostics (RMDx) may be in clinical trials.
Tunde Otulana, M.D., heads Boehringer Ingelheim’s clinical development and medical affairs group. He is a former FDA reviewer who studied, learned, and finally got the chance to apply his knowledge of clinical trials when he stepped over into industry in 1997. As a pulmonologist who previously worked for about seven years in the FDA’s pulmonary division, Otulana subsequently led related R&D efforts at several companies before coming to BI in 2011. He now plays a key role in the U.S. in preserving the company’s position as a pioneer and leader in respiratory therapy, mainly in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
SynteractHCR is a privately held contract research organization (CRO) dedicated to meeting the needs of biotech, pharmaceutical and medical device companies.
SynteractHCR, Inc. was sought out by sponsor MediciNova, a publicly traded biopharmaceutical company headquartered in San Diego, for assistance on a Phase 2 asthma trial, MN-221 Cl-007: A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MN-221 in adults with acute exacerbations of asthma.
As of 2015, InVentiv Health has completed over 70 Phase I-IV respiratory studies of various types – including those involving allergy, asthma, COPD, and cystic fibrosis. That experience has given them significant insight in overcoming the typical logistical and clinical challenges sponsors are normally faced with when conducting respiratory studies.
Savara Pharmaceuticals announced today that the first patient has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis (CF) patients.
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), recently announced significant milestones that reinforce its position as a leading eClinical trial solutions provider in Japan.
AstraZeneca recently announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).
Theravance, Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Phase 1 clinical studies.
Novartis announced recently the construction of a new state-of-the-art biotechnology production site in Singapore with an investment valued at over USD 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology.
ODM-101, a new levodopa product currently developed by Orion for the treatment of Parkinson's disease, has successfully completed Phase II Proof of Concept trial. The key results indicate that ODM-101 was more efficacious than the reference product Stalevo® in the treatment of advanced Parkinson's disease patients. The study included more than 100 patients in Europe.
Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.
GlaxoSmithKline plc (GSK) recently announced that results from five Phase III studies investigating its two candidate quadrivalent influenza vaccines (QIVs) were presented at the Influenza Vaccines for the World (IVW) congress in Valencia, Spain and the Infectious Diseases week (IDweek) congress in San Diego, USA in October.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn's disease (CD).
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).
Aeras announces that it has signed an agreement with GlaxoSmithKline Vaccines, S.A. (GSK) to jointly advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK’s proprietary M72 antigen and AS01E adjuvant.