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News Breaks
March 18, 2013
08:17 EDTSNY, MACKMerrimack completes enrollment in Phase 2 study of MM-121 in collaboration with Sanofi
Merrimack Pharmaceuticals (MACK) announced that the last patient has been enrolled in a Phase 2, open-label, randomized clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with paclitaxel versus paclitaxel alone in patients with platinum-resistant or platinum refractory advanced ovarian cancers. MM-121 is being developed in collaboration with Sanofi (SNY).
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November 21, 2014
08:25 EDTMACKMerrimack presents data from Phase 1 studies of MM-398, MM-151
Merrimack Pharmaceuticals announced data from multiple presentations. Data presented includes the first public presentation on the preclinical activity and potency of MM-131, and preclinical and clinical data on MM-151. An additional abstract details Phase 1 results from a clinical pilot study evaluating the feasibility of using ferumoxytol, an iron oxide nanoparticle, as a proxy to determine tumor responses to MM-398, nanoliposomal irinotecan. Computational modeling predicted that MM-131 would block HGF from binding to c-Met with higher potency through concurrent binding to epithelial cell adhesion molecule, an abundant protein on the cell surface of many cancer types. The models also suggested that the potency of MM-131 would increase with higher levels of EpCAM, as binding to EpCAM enables MM-131 to concentrate at the cell surface and effectively compete with HGF binding to c-Met. Preclinical studies validated this prediction and MM-131 was shown to inhibit HGF-mediated pathway activation and both the growth and migration of tumor cells across a panel of cell lines in vitro. Additionally, MM-131 inhibits tumor growth in models of c-Met-driven cancer in vivo. Overall, ferumoxytol was well tolerated. Adverse events of MM-398 therapy were consistent with previous studies, and no adverse events were directly attributable to ferumoxytol.
07:16 EDTSNYGenzyme says EU's CHMP adopts positive opinion for Cerdelga capsules
Genzyme, a Sanofi company, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Cerdelga capsules, an oral treatment for certain adults living with Gaucher disease type 1. The European Commission is expected to make a final decision on granting marketing authorization for Cerdelga in the EU in the coming months. Cerdelga was approved by the U.S. Food and Drug Administration in August, and is under review by other regulatory authorities around the world. The CHMP opinion was based on data from the Cerdelga clinical development program, which is the largest ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years.
05:39 EDTSNYMannKind, Sanofi on track to launch Afrezza in Q1, says Piper Jaffray
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November 20, 2014
06:09 EDTSNYSanofi says has potential to launch up to six new drugs in 2015
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05:22 EDTSNYRegeneron, Sanofi receive FDA Breakthrough Therapy designation in AD
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05:20 EDTMACKPharmaEngine, Merrimack receive FDA fast track designation for MM-398
PharmaEngine and its partner Merrimack Pharmaceuticals (MACK) announced that MM-398 has been granted the Fast Track designation by the FDA for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. Merrimack expects to begin the NDA submission in 2014.
November 19, 2014
09:16 EDTMACKOn The Fly: Pre-market Movers
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08:17 EDTSNYRegeneron, Sanofi report new data from six alirocumab trials
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08:07 EDTMACKMerrimack receives FDA fast track designation for MM-398
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07:52 EDTSNYInforma Business Information to hold a conference
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07:11 EDTSNYSanofi drawing up list of CEO candidates to repalce Viehbacher, Reuters reports
Sanofi's (SNY) board is in the process of drawing up a short list of CEO candidates to replace Chris Viehbacher, sources tell Reuters. Jean-Rene Fourtou, a Sanofi director and the honorary chairman of media group Vivendi (VIVHY), has been selected to lead the appointments and governance committee that will select the next CEO. Smith & Nephew (SNN) CEO Olivier Bohuon, AstraZeneca (AZN) CEO Pascal Soriot and former Wyeth CEO Bernard Poussot have been rumored to be potential contenders for the CEO position. Reference Link
November 18, 2014
15:48 EDTSNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
12:16 EDTSNYSanofi to host seminar on New Medicines
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07:20 EDTMACKEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
07:16 EDTSNYMilken Institute--Faster Cures to hold a conference
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
14:53 EDTSNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
09:15 EDTMACKMerrimack to present advances on targeted cancer molecules
Merrimack Pharmaceuticals announced that it will present research on three of its therapeutic candidates at the 2014 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 18-21. Data will be shared in four poster sessions. Presentations will include results from a clinical study using ferumoxytol as a magnetic resonance imaging agent and its ability to predict tumor response to MM-398, preclinical and clinical research on MM-151 and an initial preclinical study of MM-131, a novel bispecific antibody targeting the c-Met tumor signaling pathway.
07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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