Therapeutics News and Research

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FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

Researchers synthesize wound-healing peptides

Newly-created bioactive peptides promote wound healing through the growth of new blood vessels and epithelial tissue, such as skin. These wound-healing peptides, synthesized by researchers at the Tufts Center for Innovations in Wound Healing Research, increased angiogenesis in vitro by 200 percent.

8 Dec 2010

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

A therapy developed by Aileen Anderson and Brian Cummings of UC Irvine's Sue and Bill Gross Stem Cell Research Center in collaboration with researchers at StemCells Inc. will be the basis of the world's first clinical trial using human neural stem cells to treat spinal cord injury.

8 Dec 2010

NIH awards Scripps Research $2.35M to study new treatment for obesity

The Scripps Research Institute has been awarded a $2.35 million grant from the National Institutes of Health to study a new way of treating obesity as part of a national consortium with the Dana-Farber Cancer Institute.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

Roche completes enrollment in Herceptin SC Phase 3 trial for HER2-positive breast cancer

Halozyme Therapeutics, Inc. today announced that Roche has completed patient enrollment for the pivotal Phase 3 study of Herceptin SC (trastuzumab subcutaneous), a subcutaneous formulation that uses Halozyme's Enhanze™ technology (rHuPH20, recombinant human hyaluronidase).

7 Dec 2010

Idis to manage ViroPharma's named patient program

ViroPharma Incorporated and Idis, the global leader in developing long-term strategic solutions to therapeutic access, today announced that the two companies have partnered to facilitate access to certain ViroPharma products through a named patient program (NPP). ViroPharma's NPP, developed and managed by Idis, will allow international healthcare professionals to prescribe certain products to individual patients until the time that approval is sought in local countries.

7 Dec 2010

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

Cylene Pharmaceuticals, Inc. has been selected to present data describing the activity of their first-in-class CK2 inhibitor at the 52nd Annual Meeting of the American Society of Hematology, to be held on December 4-7 in Orlando, FL, the company announced today. Kenna Anderes, VP Cancer Biology at Cylene, will discuss research on targeting CK2, a protein kinase that is essential for the progression of multiple myeloma but that has not been previously exploited as an anticancer target.

7 Dec 2010

Rexahn Pharmaceuticals announces US patent for cognition enhancement

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that the U.S. Patent & Trademark Office has issued U.S. Patent 7,842,683 entitled, "Neurotherapeutic Compositions and Methods."

7 Dec 2010

Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

Ascenta Therapeutics, Inc. and The Leukemia & Lymphoma Society (LLS) today entered into an agreement whereby the LLS will support clinical development of Ascenta's oral small molecule inhibitor of IAPs (inhibitor of apoptosis proteins), AT-406, for patients with acute myeloid leukemia (AML).

7 Dec 2010

MU researcher hopes to protect cardiac muscles for children with DMD

Children with Duchenne muscular dystrophy face a future of rapidly weakening muscles, which usually leads to death by respiratory or cardiac failure before their 30th birthday. While researchers are hopeful that gene therapy could eventually evolve into an effective treatment, few have targeted the heart of the problem as much as Dongsheng Duan, PhD.

7 Dec 2010

HDAC inhibitors may be used to fight against skin cancers

In a study published in the journal Developmental Cell, Sarah Millar PhD, professor of Dermatology and Cell & Developmental Biology at the University of Pennsylvania School of Medicine, and colleagues demonstrate that a pair of enzymes called HDACs are critical to the proper formation of mammalian skin.

7 Dec 2010

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

ZIOPHARM Oncology, Inc. announced today that new preclinical data on the novel mechanism of its organic arsenic darinaparsin (ZIO-101) in various lymphoma models were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology in Orlando Florida.

6 Dec 2010

$Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL$

Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL

Allos Therapeutics, Inc. today reported new analysis of data from the Company's pivotal PROPEL trial of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.

6 Dec 2010

Cell Therapeutics announces new pixantrone EOS follow up results

Cell Therapeutics, Inc. today announced new pixantrone end of study follow up results from the Company's pivotal phase III PIX301 trial, which results form the basis for the Company's recent Marketing Authorization Application currently under review by the European Medicines Agency.

6 Dec 2010

Cyclacel reports preclinical data of CYC065 for treatment of cancer, other serious diseases

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, announced today the presentation of new preclinical data for CYC065, a novel, orally-available, cell cycle kinase inhibitor. The data were reported at a poster presentation at the 52nd Annual Meeting of the American Society of Hematology in Orlando, Florida.

6 Dec 2010

$Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010$

Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010

Allos Therapeutics, Inc. today reported updated results from the Company's Phase 1 dose-finding study of FOLOTYN® (pralatrexate injection) which supports the selection of 15 mg/m2 weekly for three weeks out of a four-week cycle as the optimal starting dose and schedule for further evaluation in patients with relapsed or refractory cutaneous T-cell lymphoma. Data were presented at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.

6 Dec 2010

$Pivotal PROPEL trial data of FOLOTYN in patients with refractory PTCL reported at ASH Annual Meeting$

Pivotal PROPEL trial data of FOLOTYN in patients with refractory PTCL reported at ASH Annual Meeting

Allos Therapeutics, Inc. today reported new analyses of data from the Company's pivotal PROPEL trial of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma at the 52nd American Society of Hematology Annual Meeting held in Orlando, Florida.

6 Dec 2010

HSS creates Center for Musculoskeletal Outcomes and Patient Oriented Research

Hospital for Special Surgery announced the creation of the Center for Musculoskeletal Outcomes and Patient Oriented Research to translate information collected from an extensive patient population into studies that will guide experts in preventing, diagnosing and treating musculoskeletal disorders.

4 Dec 2010

Positive results from Neuraltus NP002 Phase 1/2 study for levodopa-induced dyskinesias in Parkinson's disease

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet medical needs, primarily for the treatment of neurodegenerative diseases, announced today top-line results from the Company's Phase 1/2 clinical study of NP002 for the treatment of dyskinesias (muscle movement disorders) resulting from levodopa therapy for patients with Parkinson's disease.

4 Dec 2010

Therapeutics News and Research

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Researchers synthesize wound-healing peptides

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

NIH awards Scripps Research $2.35M to study new treatment for obesity

Contrave, new weight loss pill gets FDA panel nod

Roche completes enrollment in Herceptin SC Phase 3 trial for HER2-positive breast cancer

Idis to manage ViroPharma's named patient program

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

Rexahn Pharmaceuticals announces US patent for cognition enhancement

Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

MU researcher hopes to protect cardiac muscles for children with DMD

HDAC inhibitors may be used to fight against skin cancers

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL

Cell Therapeutics announces new pixantrone EOS follow up results

Cyclacel reports preclinical data of CYC065 for treatment of cancer, other serious diseases

Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010

Pivotal PROPEL trial data of FOLOTYN in patients with refractory PTCL reported at ASH Annual Meeting

HSS creates Center for Musculoskeletal Outcomes and Patient Oriented Research

Positive results from Neuraltus NP002 Phase 1/2 study for levodopa-induced dyskinesias in Parkinson's disease

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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