The latest shared research on Citeline
Global Standardization for Alzheimer’s Biomarkers Moves a Major Step Closer to Reality
Alzheimer's Association Analysis of APOE-e4 on amyloid deposits shows abnormal levels can be detected at least 10-years and possibly 20-years prior to onset Citeline, an Informa business unit, and the world's leading research authority on pharmaceutical clinical trials recently reviewed the findings from the 14th International Conference on Alzheimer's Disease (ICAD 2011/AAIC 2011) July 16-21, 2011, noting that while pharma continues to develop beta amyloid targeting drugs, amyloid targets are moving ahead in terms of biomarkers and early warning for risk of Alzheimer's. According to Dr. Revati Tatake, CNS Analyst at Citeline, noteworthy among the biomarkers/genomics-focused on-going studies were multiple studies under ...
Webinar: What Is The Outlook for the Pharma Top 10
Reserve a free place at our webinar to explore the challenges and opportunities facing the top 10 pharma companies: In response to the popularity of our recent focus on leading pharma companies, we are pleased to present this exclusive roundtable discussion, hosted by a panel of experts from the industry's leading research providers. This webinar presentation, only available to members of the PharmaShare community, will explore the latest trends within the evolving company landscape, including: Recent company performances that have shaped the competitive landscape and the strategies that have proven to be most effective in driving growth. The outlook for leading companies through ...
Approved Biologic Therapies in Rheumatoid Arthritis Show Further Evidence of Efficacy and Reduction in Joint Damage at the 2011 European League Against Rheumatism’s Congress
Dr. Laura Runkel, Associate Director of Autoimmune/Inflammation Claire Herman, Senior Analyst, Autoimmune/Inflammation Conference highlights include emerging predictive biomarkers, life cycle management and label expansion trials for approved biologics, along with results for Pfizer’s novel oral drug for rheumatoid arthritis. One of the major annual rheumatology conferences, the European League Against Rheumatism’s Congress (EULAR), was held May 25-28 in London. Citeline, Inc., reviewed the trends and highlights from clinical trial results reported at EULAR, noting that approved biologics in rheumatoid arthritis dominated the program, comprising roughly 25% of clinical trial abstracts presented. Updates from long-term trials for approved biologics in RA—including adalimumab, etanercept, abatacept, rituximab ...
Dalcetrapib and Anacetrapib: A Tale of Two CETPs
Gail Parziale Senior Director, Cardiovascular and Metabolic/Endocrinology Citeline Background on CETP inhibition and the torcetrapib failure Cholesteryl ester transfer protein (CETP) inhibition represents a novel treatment approach for patients with dyslipidemia. This class of drugs works by raising levels of high-density lipoprotein cholesterol (HDL-c), the so-called good cholesterol known to have antiatherogenic and cardioprotective effects. Because current treatment options for patients with decreased HDL are limited, this new therapeutic approach has generated much excitement in the medical community. Pfizer’s torcetrapib had been the front runner in this new therapeutic class when its development was unexpectedly halted in December 2006 following safety concerns that arose during ...
Big Manufacturers Stick With Tried and Tested Drug Delivery
The majority of marketed non-insulin antidiabetics are oral drugs taken in tablet form, and the pipeline continues this trend, with 63% of developmental agents (119 agents) using oral delivery. Several antidiabetics, in particular the marketed glucagon-like peptide-1 (GLP-1) agonists, use subcutaneous injections. This is likely to be an obstacle in comparison to oral antidiabetics, although advantages in efficacy or weight loss have enabled the GLP-1 agonists to gain market share. They are also competing against injectable insulin. Injectables contribute a further 40 pipeline agents, or 21% of the non-insulins pipeline; this includes a majority of subcutaneous injectables, though drugs using ...
The Number of Drugs in Phase III Development Increased By 13% Representing the Largest Year Over Year Improvement Seen
While the Numbers are Promising the Amount of Innovations Remains Limited Citeline recently completed its comprehensive year on year assessment of the pharmaceutical industry's drug development pipeline. Citeline's 2011 Annual Review of Trends in Pharmaceutical R&D released on June 24 found that the overall size and potential of the pharmaceutical industry, as judged by growth in its drug development pipeline, remained flat, although improvements were seen in certain specific trends, foretelling of possible better times ahead. Ian Lloyd, Editorial Director of Citeline's Drug Information Service, commented that while overall drug development did not grow the number of drugs entering Phase III trials ...
Pfizer – Demonstrating Leadership in Segmented Medicine?
Rachel Meighan-Mantha, PhD, Senior Analyst, Oncology, Citeline At Pfizer’s ASCO investor presentation and conference call, Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs, Oncology, expounded on Pfizer’s improved approach to oncology drug development as targeting small but optimal segments in given patient populations. They hope that their version of personalized medicine will provide bigger treatment differences in smaller clinical trials, less costly and faster trial completions and earlier regulatory submissions. Pfizer hopes to commercialize drugs for these optimal patient segments so that patients, payers and Pfizer all benefit. It’s a “win-win-win situation” stated Mr. Rothenberg. Crizotinib, a dual ALK/MET ...
Sanofi’s Semuloparin Shows Efficacy with Cancer Patients, but is it Enough to Differentiate?
Jake Mathon, Senior Analyst, Cardiovascular & Metabolic/Endocrinology, Citeline In a late-breaking presentation at ASCO, investigators announced that Sanofi’s experimental drug semuloparin, a selectively engineered ultra- low molecular weight heparin, reduced VTE risk 64% in cancer patients initiating chemotherapy. The results of the Phase III SAVE-ONCO trial of 3,212 patients showed a rate of 1.2% for semuloparin vs. 3.4% for placebo in the primary endpoint of composite of symptomatic-deep vein thromboembolism (DVT), non-fatal pulmonary embolism (PE) or venous thromboembolism (VTE)-related death. Semuloparin’s efficacy in reducing VTE came with similar incidences of major bleeding compared to placebo (1.2% vs. 1.1% respectively) and slightly ...
Is GlaxoSmithKline Breathing Easier or Holding its Breath? Mixed Results of Two Pivotal Phase 3 fixed-dose Combination Studies in COPD are Reported
Dr. Cydney Brooks, Citeline Senior Director, Editorial Special Projects GlaxoSmithKline and partner Theravance reported results from two pivotal 6-month Phase 3 studies of Relovair in COPD last week. Relovair is a once-daily, fixed-dose combination (FDC) product containing the inhaled corticosteroid (ICS) fluticasone furoate and the long-acting beta-agonist (LABA) vilanterol and is in development for COPD and asthma. These COPD studies provide promising Relovair results in that the improvements in primary endpoints for lung function were statistically significant compared to placebo. However, the overall picture is not clear. Relovair produced “numerically better”, but not statistically significant, improvement in lung function when compared ...
Novartis Poised to Put Gout Sufferers Out Of Their Misery
Christine Blazynski, PhD Sr. Vice-President, Product Development Citeline This week’s EULAR meeting provides insight into the race between Novartis’ canakinumab and Regeneron’s rilonacept for the growing gout market. Both companies report overwhelming positive results from pivotal Phase III trials. But Novartis likely has an edge in this race given that the two pivotal trials (ß-RELIEVED and ß-RELIEVEDII) included an active comparator compared to the placebo-control design used in Regeneron’s Presurge-1 and 2 trials. The two companies had a similar growth strategy for their therapies that target IL-1β. Both companies’ drugs have been approved for the rare diseases Familial cold inflammatory syndrome and Muckle-Wells syndrome. ...
