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Metamark Genetics closes $22M Series B financing

Metamark Genetics, Inc., a molecular diagnostics company addressing a major challenge in cancer medicine, has completed a $22 million Series B financing. Metamark's Prognosis Determinants platform has illuminated the genetic drivers governing the lethal metastatic progression of major cancers and is now focused on pivotal translational and commercialization efforts to bring these breakthrough discoveries to cancer patients worldwide.

14 Jul 2010

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States.

14 Jul 2010

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

K-V Pharmaceutical Company, a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for Gestiva™ (hydroxyprogesterone caproate injection), 250 mg/mL.

14 Jul 2010

Mass. lawmakers may strip ban on medical-industry gifts

Massachusetts lawmakers may repeal a two-year old law requiring medical firms to disclose gifts to doctors, The Associated Press/Boston Herald reports. "Health care advocates say such a move could put a quick halt to efforts to rein in health care costs and increase transparency in the industry. Those pushing for repeal say the law has made it harder to attract those businesses to the state.

14 Jul 2010

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

14 Jul 2010

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

A new Australian drug has been shown to assist in protecting patients with a rare genetic disorder that makes their skin toxic to light and UV, and previously forced them to live in the shadows.

13 Jul 2010

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Hi-Tech Pharmacal Co., Inc. today reported results for the fourth quarter and year ended April 30, 2010.

13 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

RXi Pharmaceuticals receives SBIR grant to further develop novel RNAi therapeutics

RXi Pharmaceuticals Corporation, a recognized leader in RNAi-based therapeutic discovery and development, today announced that it was awarded an Advanced Technology Small Business Innovation Research grant by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

13 Jul 2010

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

BioSante Pharmaceuticals, Inc. today announced the initiation of a LibiGel (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.

13 Jul 2010

First Edition: July 13, 2010

Today's health policy headlines include a report about state preparations to cut Medicaid spending as the federal funding stalemate continues and a status check on the start up of high-risk pools.

13 Jul 2010

Roche obtains global co-exclusive license for PI3K biomarker from QIAGEN

Roche announced today that the company has obtained a worldwide co-exclusive license for the biomarker PI3K (phosphoinositide 3-kinase) from QIAGEN to develop real-time and endpoint PCR diagnostic assays. Johns Hopkins University owns the patent for the PI3K biomarker and has previously granted an exclusive license to QIAGEN's wholly owned subsidiary DxS, now QIAGEN Manchester.

From QIAGEN Manchester Limited 13 Jul 2010

New study on impact of bortezomib on mantle cell lymphoma

A new study by researchers from the John Theurer Cancer Center at Hackensack University Medical Center sheds light on how bortezomib (VELCADE-), the first in a new class of cancer drugs known as proteasome inhibitors, works in mantle cell lymphoma. The study also provides preliminary evidence for which patients might benefit most from bortezomib.

13 Jul 2010

Encap Drug Delivery granted patents in US, Europe for DuoCap capsule delivery system

Encap Drug Delivery, a leading provider of development and manufacturing services to the pharmaceutical industry, has received confirmation that their DuoCap™, capsule delivery system has been granted patents for US and Europe.

13 Jul 2010

Sheffield Bio-Science honored with 2010 Lilly Global Supplier Award

Sheffield Bio-Science, a leading global pharmaceutical supplier of superior quality cell nutrition and excipient products for the biotech and pharmaceutical markets, has been awarded the distinguished 2010 Lilly Global Supplier Award.

13 Jul 2010

CSHL scientists reverse symptoms of Type III SMA using ASOs

The devastating, currently incurable motor-neuron disease spinal muscular atrophy might soon be treated with tiny, chemically modified pieces of RNA called antisense oligonucleotides.

13 Jul 2010

HighRes Biosolutions to provide high-throughput screening automation to Rigel

HighRes Biosolutions, the leader in laboratory automation solutions for life science, announced today that it will be providing high-throughput screening automation to Rigel Pharmaceuticals, a South San Francisco, California-based clinical-stage drug development company.

13 Jul 2010

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet. Watson's sevelamer carbonate for oral suspension product is the generic version of Genzyme's Renvela for Oral Suspension.

13 Jul 2010

AnaptysBio awarded DARPA contract to generate novel high affinity thermally stable antibodies

AnaptysBio, Inc., a privately-held therapeutic antibody platform and product company, today announced it has been awarded a contract by the Defense Advanced Research Projects Agency (DARPA), to use its proprietary somatic hypermutation (SHM) technology platform to generate novel high affinity thermally stable antibodies that could be used by the military in antibody-based biosensors, including those that can detect bioterrorist threats.

13 Jul 2010

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

Threshold Pharmaceuticals, Inc., today announced two preclinical presentations on its clinical stage hypoxia-activated prodrug, TH-302, at the American Association for Cancer Research Translational Cancer Medicine Meeting, being held July 11 to 14, 2010, in San Francisco, CA. The preclinical presentations describe new findings regarding the efficacy of TH-302 when combined with multi-kinase inhibitors that inhibit VEGF signaling, as well as the efficacy of TH-302 in combination with gemcitabine in models of pancreatic cancer.

13 Jul 2010

Pharmaceuticals News and Research

Metamark Genetics closes $22M Series B financing

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

Mass. lawmakers may strip ban on medical-industry gifts

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

RXi Pharmaceuticals receives SBIR grant to further develop novel RNAi therapeutics

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

First Edition: July 13, 2010

Roche obtains global co-exclusive license for PI3K biomarker from QIAGEN

New study on impact of bortezomib on mantle cell lymphoma

Encap Drug Delivery granted patents in US, Europe for DuoCap capsule delivery system

Sheffield Bio-Science honored with 2010 Lilly Global Supplier Award

CSHL scientists reverse symptoms of Type III SMA using ASOs

HighRes Biosolutions to provide high-throughput screening automation to Rigel

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

AnaptysBio awarded DARPA contract to generate novel high affinity thermally stable antibodies

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

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