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ERYtech Pharma receives ODD for its GRASPA from FDA

ERYtech Pharma announces that FDA has granted an Orphan Drug Designation (ODD) for GRASPA®, the company’s lead product in Acute Lymphoblastic Leukaemia.

27 Jan 2010

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.

27 Jan 2010

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

25 Jan 2010

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

25 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients.

24 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

USPTO issues new patent for Advaxis' intellectual property portfolio

The U.S. Patent and Trademark Office (USPTO) issued today patent 7,635,479, "Compositions and Methods for Enhancing the Immunogenicity of Antigens,” by Dr. Yvonne Paterson, et al, which is assigned to the Trustees of the University of Pennsylvania and licensed to Advaxis, Incorporated (OTCBB: ADXS).

22 Jan 2010

Data from GenVec's trial in esophageal cancer showcased at 2010 Gastrointestinal Cancer Symposium

GenVec, Inc. announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.

22 Jan 2010

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

hESC "reporter" line to measure endothelial cell production and activity

New York Stem Cell Foundation (NYSCF)-Druckenmiller Fellow, Daylon James, PhD, of Weill Cornell Medial College, is lead author on a study defining conditions for generating a plentiful supply of endothelial (vessel lining) cells that are suitable for therapeutic use. Dr. James and his colleagues created a human embryonic stem cell (hESC) "reporter" line that can be used to measure endothelial cell production and activity.

22 Jan 2010

Norepinephrine responses to bucindolol influenced by alpha-2C adrenergic receptor genotype

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular disease, today announced that the paper “An alpha-2C-Adrenergic Receptor Polymorphism Alters the Norepinephrine Lowering Effects and Therapeutic Response of the Beta Blocker Bucindolol in Chronic Heart Failure” was published in the January 2010 edition of the peer-reviewed journal Circulation: Heart Failure (http://circheartfailure.ahajournals.org).

22 Jan 2010

CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

NicOx receives EMEA approval for naproxcinod MAA

NicOx S.A. today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the US Food and Drug Administration (FDA) in November 2009.

22 Jan 2010

Study shows usefulness of handheld devices for teleconsultation and emergency procedures

Handheld devices such as personal digital assistants (PDAs) and the iPod Touch are prevalent among doctors. However a recent study shows that these devices may be particularly useful for emergency radiologists, who in the near future, may be able to use them for teleconsultation and emergency procedures, according to a study published in the February issue of the American Journal of Roentgenology.

22 Jan 2010

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

Depomed receives second $500,000 milestone payment from Covidien

Depomed, Inc. announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology. The most recent payment from Covidien, which was received in December 2009, relates to the development of a formulation for the second product candidate under the collaboration.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

Efficacy of neurofeedback in treating ADD/ADHD

On January 22, the Potomac Institute for Policy Studies will present a guest lecture by Don DuRousseau, founder and CEO of Human Bionics LLC, a neurotechnology company specializing in brain-computer interface (BCI) systems. Mr. DuRousseau will explore the use of neurotechnology techniques, including the increasingly popular neurofeedback, as a treatment for ADD/ADHD.

21 Jan 2010

Results of two pivotal Phase III clinical trials with oral FTY720 published

Results of the TRANSFORMS and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).

21 Jan 2010