Repurposing marketed drugs or rescuing compounds that failed in clinical trials offers entrepreneurs the potential to replenish pipelines with reduced risk and time.
Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.
March and April are traditionally two months that for me involve an unusual amount of business travel. What is different about this year is that the indications under discussion have included depression, schizophrenia, ADHD, Parkinson’s disease, Alzheimer’s disease and a variety of other diseases, including hypertension, diabetes and fibromyalgia. By John Harrison, PhD, Scientific Consultant, CRF Health
Every now and then, a shift in technology revolutionizes an entire industry. Consider the advent of email and automatic banking machines. Once the mainstream adopts these processes, it is difficult to imagine how we managed without them. By Valdo Arnera, MD, General Manager of PHT Corporation Europe
The process of discovering and bringing a drug to market consists of several stages, beginning with identification and validation of a drug target and continuing through lead identification by high-throughput screening, lead optimization, and profiling in relevant disease models.
ePharmaSolutions, a global study launch and site support services company, developed and deployed a highly effective patient recruitment campaign that yielded an outstanding number of qualified referrals to support an osteoarthritis of the knee study in patients that were currently on a medication regimen.
PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. From the start, the PRA study team faced a shortened enrollment period and other timeline challenges, including the protocol’s late delivery as well as problems with the vaccine’s availability.
Many biopharmaceutical companies are exploring new types of strategic partnerships to help them save time and money during the most challenging and costly stage of product development – pivotal Phase IIb/III clinical trials.
This week Cellular Biomedicine Group (OTCQB: CBMG) held a ceremony to mark the launch of their clinical trial for haMPC (Human Adipose-derived Mesenchymal Progenitor Cells) therapy for Knee Osteoarthritis (KOA).
PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-CRPRx in patients with paroxysmal atrial fibrillation.
Doctors currently struggle to determine whether a breast tumor is likely to shift into an aggressive, life-threatening mode—an issue with profound implications for treatment.
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.
Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
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).
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).
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate.
Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext in Paris, with a focus on research and development of new treatments against proliferative diseases, recently announces the start of a phase II clinical trial of oral inecalcitol in patients with chronic lymphocytic leukemia (CLL).
Janssen Biologics (Ireland) announced today it has initiated the Phase 3 development program for sirukumab (CNTO 136) as part of a collaboration with GlaxoSmithKline plc (GSK).
Los Altos, CA /PRNewswire-iReach/ - AbGenomics International announced today that it has obtained agreement from U.S. Food and Drug Administration (FDA) for its proposed plans for a phase 2 clinical trial of the novel autoimmune therapeutic candidate, AbGn-168H.
Amgen (NASDAQ: AMGN) today announced a decision to stop the ganitumab (AMG 479) Phase 3 GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial.
TiGenix (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis.
