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Tuesday, 31 January 2012 23:10 |
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BioSante Pharmaceuticals alerted investors this morning to its plan to move forward after the colossal failure of its late-stage trials for its female libido gel last month. To save cash, the company said it's cutting 21 full-time employees or contractors, about a quarter of its total workforce, and is hunting for in-licensing, merger and acquisition deals. |
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Tuesday, 17 January 2012 22:27 |
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ROCHESTER, Minn. — An investigational drug called regorafenib slowed the progression of tumors and lengthened the lives of patients with metastatic colorectal cancer, an international phase III clinical trial found. The findings were presented today at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in San Francisco by Mayo Clinic oncologist Axel Grothey, M.D., principal investigator of the trial in the United States. |
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Tuesday, 13 December 2011 05:48 |
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Ariad Pharmaceuticals Inc. (ARIA)’s experimental drug ponatinib spurred a positive response in 47 percent of chronic myeloid leukemia patients, a pivotal study the company said may help the medicine gain approval as a new therapy for people without treatment options. |
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Monday, 12 December 2011 05:30 |
PCI-32765 applies molecularly aimed attack to disease usually treated with chemotherapy combinations SAN DIEGO - A new, targeted approach to treating chronic lymphocytic leukemia has produced durable remissions in a Phase I/II clinical trial for patients with relapsed or resistant disease, investigators report at the 53rd Annual Meeting of the American Society of Hematology. |
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Monday, 21 November 2011 06:58 |
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Treatment with dexpramipexole – a novel drug believed to prevent dysfunction of mitochondria, the subcellular structures that provide most of a cell's energy – appears to slow symptom progression in the neurodegenerative disease amyotrophic lateral sclerosis (ALS). Promising results of a phase 2 trial of dexpramipexole are receiving advance online publication in Nature Medicine. Some preliminary results of the study were presented at the 2009 International Symposium on ALS/MND and the 2010 American Academy of Neurology annual meeting. |
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Tuesday, 15 November 2011 06:43 |
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Rivaroxaban Used in Combination with Standard Therapy Reduced Cardiovascular Death by Over 30%Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that adding oral rivaroxaban to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks or strokes in patients with acute coronary syndrome (ACS) compared to those receiving standard therapy alone. Results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial presented today at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine also showed that rivaroxaban significantly increased rates of major bleeding, but did not create an excess risk of fatal bleeding over standard therapy alone. |
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Wednesday, 02 November 2011 06:13 |
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An experimental drug called Ocrelizumab has shown promise in a Phase 2 clinical trial involving 220 people with multiple sclerosis (MS), an often debilitating, chronic autoimmune disease that affects an increasing number of people in North America. It usually strikes young adults and is more common in women than in men. |
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Tuesday, 01 November 2011 05:38 |
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Exelixis has been talking with the FDA for months about reaching an agreement on the design of a pivotal trial for its prostate cancer drug, but now the company has essentially thrown up its hands and decided to push ahead in testing without any formal regulatory deal. Shares of the company fell more than 30 percent, to $5.36, in after-hours trading following the announcement. |
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Wednesday, 26 October 2011 06:03 |
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A Phase III study evaluating Bayer HealthCare Pharmaceuticals’ regorafenib (Bay 73-4506) in patients with metastatic colorectal cancer (mCRC) has been unblinded to allow patients in the placebo arm to start receiving the investigational oral multikinase inhibitor. The Correct study is being conducted in 760 mCRC patients whose disease had progressed after approved standard therapy. Patients are randomized to receive either regorafenib plust best supportive care, or placebo plus best supportive care. |
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Saturday, 22 October 2011 02:56 |
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Today Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) announced additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis (RRMS).
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Tuesday, 17 January 2012 23:11 |
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The last flickering hope that Medivation's Dimebon could help Alzheimer's disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure. |
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Wednesday, 21 December 2011 07:45 |
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AstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, may need to change its drug development strategy after setbacks with experimental treatments for cancer and depression, analysts said. A medicine called olaparib won’t move to the next stage of clinical trials to treat a type of ovarian cancer and a second advanced study of another drug for patients with major depressive disorder failed to meet the main goal, AstraZeneca said in statement today. As a result, AstraZeneca will take a charge of $381.5 million in the fourth quarter. |
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Tuesday, 13 December 2011 05:37 |
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Dec. 10 (Bloomberg) -- Pfizer Inc.’s blood-cancer drug Mylotarg, pulled from the market last year after it was linked to deaths, helped a different group of patients, a study found. Patients newly diagnosed with acute myeloid leukemia who received Mylotarg with chemotherapy lived for 25 months after treatment, compared with 15 months for those given chemotherapy alone, according to the study released today at the American Society of Hematology meeting in San Diego. Mylotarg had previously been used in patients ages 60 and older only after their cancer had returned. |
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Thursday, 01 December 2011 05:37 |
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CHAPEL HILL, N.C. – Researchers at the University of North Carolina at Chapel Hill have shown that it is safe to cut and paste together different viruses in an effort to create the ultimate vehicle for gene therapy. In a phase I clinical trial, the investigators found no side effects from using a "chimeric" virus to deliver replacement genes for an essential muscle protein in patients with muscular dystrophy. |
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Tuesday, 15 November 2011 06:51 |
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Pfizer Inc. and Bristol-Myers Squibb Co.’s experimental drug apixaban wasn’t safer or more effective than a standard treatment in stopping blood clots in the legs and lungs of patients after hospitalization, a study found. |
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Tuesday, 15 November 2011 06:31 |
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (LEMTRADA™) as compared with Rebif® (44 mcg subcutaneous interferon beta-1a). Results for both of these co-primary endpoints were highly statistically significant. |
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Tuesday, 01 November 2011 06:44 |
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MISSION VIEJO, CA--(Marketwire - November 01, 2011) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (PINKSHEETS: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced preliminary results from a study of AEOL 10150 and Neupogen® conducted by Christie Orschell, PhD of Indiana University. The primary endpoint of the study was to determine drug-drug interactions between Neupogen® and AEOL 10150, as well as to monitor safety and tolerability of the two treatments given simultaneously. Results of the study confirmed that AEOL 10150 does not interfere with the positive effects of Neupogen® on the hematopoietic, or bone marrow, syndrome of Acute Radiation Syndrome (ARS), and the two products in combination were safe and well tolerated. |
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Thursday, 27 October 2011 04:59 |
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SAN DIEGO, October 25, 2011 — Conatus Pharmaceuticals Inc. announced today the termination of its Phase 2 clinical trial of CTS-1027 in HCV patients. This decision follows reports of laboratory abnormalities and adverse events in a subset of clinical trial participants.
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Sunday, 23 October 2011 01:09 |
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WESTON, Mass., Oct 21, 2011 (BUSINESS WIRE) -- Today Biogen Idec announced positive data from the Phase 3 DEFINE clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo. Detailed data from DEFINE will be presented at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, including a platform presentation on Friday, October 21, 2011 at 9:30 a.m. CEST. |
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Saturday, 22 October 2011 02:54 |
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Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (Lemtrada™) to Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS).
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