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Enrollment complete in SUSTAIN Phase 2b clinical trial for atherosclerotic CVD

Resverlogix Corp. today announced that SUSTAIN, a Phase 2b clinical trial comprised of 176 subjects, is fully enrolled.

28 Nov 2011

European Commission approves ONGLYZA as combination therapy with insulin for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved ONGLYZA (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes.

28 Nov 2011

Laminar air flow therapy via novel device could be beneficial for asthmatics: Study

A new device that offers drug-free bedside filtered air flow can significantly reduce patients' symptoms such as wheezing and tight chests in asthmatics. The temperature controlled laminar airflow treatment, called Protexo, filters out airborne triggers such as dust particles and mites, pet hairs and powders that cause irritation and inflammation of the lungs.

27 Nov 2011

Drug for midnight waking gets FDA approval

Transcept Pharmaceuticals Inc. has received the Food and Drug Administration (FDA) approval for its drug Intermezzo - a drug that can help people get back to sleep after waking in the middle of the night. The treatment contains a low-dose of zolpidem tartrate, the active ingredient in Paris-based Sanofi’s sleeping pill Ambien.

27 Nov 2011

Transcept receives FDA approval for Intermezzo to treat insomnia

The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

23 Nov 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

Treatment of Type 1 diabetes patients with DiaPep277- may have several medical benefits

The clinical trial was random, regulated, double-blinded and broad-based. The drug was tested on 457 patients, aged 16-45, who had been diagnosed with Type 1 diabetes a short time before joining the trial. The trial took place in around 40 medical centers in Europe, Israel and South Africa. The patients in the trial were randomly assigned to one of two groups: One received the trial drug (DiaPep277-) through a subcutaneous injection once every three months, for a period of two years, while the control group was given a placebo in the same way.

23 Nov 2011

FDA accepts Regeneron's ARCALYST sBLA for review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.

22 Nov 2011

FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

22 Nov 2011

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Knopp Biosciences LLC today announced the publication in Nature Medicine of comprehensive results from the Phase 2 study of dexpramipexole, a small-molecule modulator of mitochondrial bioenergetics, in people with amyotrophic lateral sclerosis.

21 Nov 2011

Novel antibacterial protein could prevent or treat E. coli O157:H7-induced food-borne infections

A novel antibacterial protein targeted against E. coli O157:H7 may offer a way to prevent or treat serious food-borne bacterial infections, as demonstrated in a study published in the December issue of Antimicrobial Agents and Chemotherapy.

21 Nov 2011

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

ZIOPHARM Oncology, Inc. announced today the publication of a darinaparsin (Zinapar or ZIO-101) study in the PLoS ONE, an international, peer-reviewed, open-access, online publication of the Public Library of Science.

21 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

EU's FP7 programme provides €6M grant for Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial

Dr Patricia Kearney, Department of Epidemiology & Public Health, UCC is one of a group of researchers from European Universities who will participate in a new research project investigating current treatment practices for people who suffer from a mildly underactive thyroid gland.

21 Nov 2011

Gilead enters agreement for Pharmasset acquisition

Gilead Sciences, Inc. and Pharmasset, Inc. announced today that the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.

21 Nov 2011

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive preliminary results from its Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

21 Nov 2011

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention.

21 Nov 2011

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Convergence Pharmaceuticals Limited, the company focused on the development of novel and high value analgesic medicines, today announces that the multiple ascending dose Phase I study of the novel, first in class calcium channel blocker CNV2197944, for the treatment of chronic pain has been initiated.

21 Nov 2011

Avidocin protein could prevent or treat E. coli O157:H7-induced diarrhea

21 Nov 2011

Promising results from dexpramipexole phase 2 trial on ALS

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.

20 Nov 2011

Placebo News and Research

Enrollment complete in SUSTAIN Phase 2b clinical trial for atherosclerotic CVD

European Commission approves ONGLYZA as combination therapy with insulin for type 2 diabetes

Laminar air flow therapy via novel device could be beneficial for asthmatics: Study

Drug for midnight waking gets FDA approval

Transcept receives FDA approval for Intermezzo to treat insomnia

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Treatment of Type 1 diabetes patients with DiaPep277- may have several medical benefits

FDA accepts Regeneron's ARCALYST sBLA for review

FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Novel antibacterial protein could prevent or treat E. coli O157:H7-induced food-borne infections

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

EU's FP7 programme provides €6M grant for Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial

Gilead enters agreement for Pharmasset acquisition

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Avidocin protein could prevent or treat E. coli O157:H7-induced diarrhea

Promising results from dexpramipexole phase 2 trial on ALS

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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