|Lilly to Present Data Across Diabetes Portfolio; Dendreon Reports Marketing Authorization for Provenge|
|By Staff and Wire Reports|
|Tuesday, 17 September 2013 18:42|
Eli Lilly and Company (NYSE: LLY) announced that a total of 31 abstracts will be presented at the 49^th European Association for the Study of Diabetes Annual Meeting in Barcelona, September 23-27. In seven presentations, Lilly will share Phase III data for dulaglutide, its investigational GLP-1 receptor agonist, and Phase II data for LY2605541, its investigational novel basal insulin analog.
Seventeen abstracts will be presented by Boehringer Ingelheim on behalf of the Alliance with Lilly.
Lilly will present an additional seven abstracts, including research from its early-stage pipeline. Lilly's pipeline comprises nearly a dozen potential new medicines for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms.
Following are details on some of the presentations from Lilly's late-stage pipeline.
Dulaglutide Data Six dulaglutide abstracts will be presented, including efficacy, safety and health outcomes data from the Phase III programme. One of these abstracts will be given as an oral presentation. Details for the presentations are as follows:
o Tuesday, 24 September 2013, 10:45-12:15 CEST, Oral Presentation
o Efficacy and safety of dulaglutide vs metformin in type 2 diabetes (AWARD-3) (Santiago Tofe Povedano) [Presentation 4]
o Tuesday, 24 September 2013, 13:45-14:45 CEST, General Poster Session
o Dose-finding results in an adaptive trial of dulaglutide combined with metformin in type 2 diabetes (AWARD-5) (Zachary Skrivanek) [Poster No. 1003]
o Thursday, 26 September 2013, 13:45-14:45 CEST, General Poster Session
o Efficacy and safety of dulaglutide versus placebo and exenatide in type 2 diabetes (AWARD-1) (Carol Wysham) [Poster No. 919] o Safety and efficacy of dulaglutide vs sitagliptin after 104 weeks in type 2 diabetes (AWARD-5) (Bruno Guerci) [Poster No. 920] o Efficacy and safety of dulaglutide vs sitagliptin after 52 weeks in type 2 diabetes (AWARD-5) (Michael Nauck) [Poster No. 921] o Patient-reported outcomes with dulaglutide, exenatide, or placebo (AWARD-1) (Kate Van Brunt) [Poster No. 985]
Novel Basal Insulin Analog (LY2605541) Data One Phase II abstract will be presented for LY2605541. Details for the presentation are as follows:
o Thursday, 26 September 2013, 12:30-13:30 CEST, General Poster Session
o LY2605541 exhibits a flatter glucodynamic profile than insulin glargine at steady state in subjects with type 1 diabetes (Linda Morrow) [Poster No. 1030]
Dendreon Corporation (Nasdaq: DNDN) announced that the European Commission (EC) has granted marketing authorization for PROVENGE^® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorization in the EU.
The marketing authorization provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health records (EHR), practice management, and care coordination announced today that its Chief Executive Officer, Jonathan Bush, has been named "CEO of the Year" by the Massachusetts Technology Leadership Council (MassTLC).
ATMI, Inc. (Nasdaq:ATMI), a global technology company and leader in single-use bioprocess solutions, announced today it has invested in sterile connector and sterile fill technology developed by Medical Instill Technologies (Medinstill), a company dedicated to developing solutions for the transfer and packaging of high purity fluids at unmatched safety levels.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced highlights to be presented at the company's Research and Development Day for the investment community to be held today from 8:00 a.m. to 12:00 p.m. ET.
Complete Genomics, Inc. (formerly NASDAQ: GNOM), a wholly-owned subsidiary of BGI-Shenzhen, a leading international genomics organization based in Shenzhen, China, today announced that it has appointed Ethan Knowlden as senior vice president, general counsel, and secretary.
eHealth, Inc. (NASDAQ: EHTH), which operates eHealthInsurance.com, the nation's first and largest private online health insurance exchange, released results from a survey of short-term health insurance policy holders showing that a majority (52%) purchased short-term plans because they expect to enroll in another form of coverage within one year.
InspireMD Inc. (NYSE MKT: NSPR), a leader in embolic protection stents, today announced financial results for its fourth quarter and fiscal year ended June 30, 2013.
LabStyle Innovations Corp. (OTCQB:DRIO), developer of the Dario™ smartphone-based medical device and diabetes management system, announces its participation in the Rodman & Renshaw 15th Annual Healthcare Conference, to be held September 9-10, 2013 at the Millennium Broadway Hotel in New York City.
Magellan Pharmacy Solutions, a division of Magellan Health Services (NASDAQ: MGLN), will host its 10th annual Oncology Summit – What You Don’t Know Can Hurt You – on September 18 and 19 in Baltimore, Maryland.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today announced that it will host the Analyst and Investor Update Call with Webcast on Tuesday, September 24, 2013, from 9:00 a.m. - 11:00 a.m. (EDT).
Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today it has contracted Inno Biologics Sdn. Bhd. to generate cell clones that are the basis of the Company's future Phase 3 cancer clinical trials.
Nuvilex, Inc. (OTCQB: NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today it has contracted Fisher BioServices, Inc. for the long-term storage of cells that will be required for its future Phase 3 and other cancer clinical trials.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Rainier™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen (OGX-427) in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.
OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the Annual Rodman & Renshaw 2013 Global Investment Conference in New York City.
PDI, Inc. (Nasdaq: PDII) today announced the signing of a collaboration agreement with a privately held molecular diagnostics company (the Company) to commercialize the Company's molecular diagnostic tests.
PeptiDream Inc, a public Tokyo-based biopharmaceutical company (“PeptiDream”) (TOKYO:4587) announced today that it has entered into a Technology License Agreement with US-based Bristol-Myers Squibb (NYSE:BMY) to nonexclusively license PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) technology.
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified company focused on generating profitable revenues through license agreements and evaluating potentially lucrative acquisition targets in an industry agnostic manner, has today provided shareholders with a brief update on meaningful fundamental progress in implementing its business plan and future aspirations.
TriStar Wellness Solutions, Inc. (OTCQB:TWSI), a health and wellness company that targets opportunities in the self-care and professional marketplace, has now hired several key positions for nationwide sales coverage and marketing communications for its wholly owned subsidiary HemCon Medical Technologies Inc.