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BioMarin announces preliminary results from ADAPT in patients suffering from PKU

BioMarin Pharmaceutical Inc. announced today preliminary results from ADAPT (A Diversified Approach for PKU Treatment) in an abstract (Abstract #91, Mental Health Screening in Phenylketoniuria Clinic) presented by Barbara Burton, MD at the 2011 annual American College of Medical Genetics conference in Vancouver, Canada.

19 Mar 2011

KYTHERA presents additional data from third ATX-101 Phase II clinical study in submental fat reduction

KYTHERA Biopharmaceuticals, Inc. today presented additional efficacy data from a third Phase II clinical study with ATX-101, a first-in-class adipolytic agent that is under investigation for the reduction of submental ('under the chin') fat. The expanded analysis focused on additional patient reported outcome measures, including instruments measuring submental fat impact, subject global assessments and subject self-ratings of chin attractiveness.

18 Mar 2011

New study: Men who consume hair loss drug may report sexual dysfunction

A new study by The George Washington University School of Medicine and Health Sciences, that will be published in the Journal of Sexual Medicine, suggests men who take the drug finasteride, commonly marketed under the trademark names Propecia and Proscar, may report an on-going reduction in sex drive, and in some cases, prolonged periods of erectile dysfunction even after they stop using the medications.

18 Mar 2011

FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

FibroGen, Inc., today announced that FibroGen and partner Astellas Pharma Inc. advanced FG-4592 (Astellas designation ASP1517), an investigational anemia therapy, to phase 2b development for treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.

18 Mar 2011

Gene therapy for Parkinson’s: It works!

A latest study has shown that gene therapy may be successful in treating the dreaded brain degenerative disease – Parkinson’s disease. Neurologists are hopeful that it could be useful in other neurologic disorders too.

17 Mar 2011

PsiOxus commences MT-102 Phase II study for treatment of cancer- and age-related wasting

PsiOxus Therapeutics, Ltd. announced initiation of a Phase II study of MT-102, a small molecule therapeutic for the treatment of cancer- and age-related wasting. MT-102 is being developed to reverse the effects of cachexia, a wasting disease that accompanies cancer, heart failure, COPD, renal failure, cirrhosis and rheumatoid arthritis, and that is associated with significant morbidity and mortality.

17 Mar 2011

New lozenge clinical trial for dry mouth treatment

A clinical trial using an all-natural lozenge to treat dry mouth, a condition that impacts 40 percent of American adults, is under way at Georgia Health Sciences University College of Dental Medicine.

17 Mar 2011

New study: Positive outcomes from gene therapy trial in patients with Parkinson's

A multi-center gene therapy trial for patients with advanced Parkinson's disease demonstrated reduced symptoms of the progressive movement disorder, according to a new study published in Lancet Neurology.

17 Mar 2011

Gene therapy holds promise for Parkinson's treatment

A first-of-its-kind study of gene therapy in the treatment of Parkinson's disease determined that half of all patients who received the treatment had "clinically meaningful improvements" of their symptoms within six months of surgery.

17 Mar 2011

New omalizumab medication may reduce seasonal asthma attacks in children

A new anti-asthma medication dramatically reduced increases in seasonal asthma attacks in children and young adults with allergic asthma, according to a multi-institutional study involving a UT Southwestern Medical Center physician.

17 Mar 2011

Results from first successful phase 2 trial of gene therapy for Parkinson's or any neurologic disorder

A gene therapy called NLX-P101 dramatically reduces movement impairment in Parkinson's patients, according to results of a Phase 2 study published today in the journal Lancet Neurology. The approach introduces a gene into the brain to normalize chemical signaling.

16 Mar 2011

Fibrocell Science submits azficel-T final study report to FDA

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a final study report to the U.S. Food & Drug Administration (FDA) for a completed, six-month histological study examining skin after injections of azficel-T.

16 Mar 2011

RegeneRx RGN-352 Phase 2 trial in acute myocardial infarction placed on clinical hold

RegeneRx Biopharmaceuticals, Inc. announced that it has received a notice from the U.S. Food and Drug Administration (FDA) indicating that, due to non-compliance with FDA's current Good Manufacturing Practice (cGMP) regulations by its contract manufacturer, the Company's Phase 2 clinical trial of RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial infarction (AMI), has been placed on clinical hold.

16 Mar 2011

Cortex enters agreement with Biovail to regain AMPAKINE assets and rights

Cortex Pharmaceuticals, Inc. announced that it has entered into an agreement with Biovail Laboratories International SRL, a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc., to regain the AMPAKINE® assets and rights related to respiratory depression.

16 Mar 2011

Montreal Heart Institute and Cerenis commence CER-001 Phase 2 study in acute coronary syndrome

The Montreal Heart Institute today announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly QUicken Atherosclerosis REgression?) study of CER-001 in patients with acute coronary syndrome (ACS), in collaboration with Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases.

16 Mar 2011

AstraZeneca commences NKTR-118 Phase III clinical programme for opioid-induced constipation

AstraZeneca today announced enrolment of the first patient in the Phase III clinical programme for NKTR-118, an oral peripherally-acting opioid antagonist being investigated for the treatment of opioid-induced constipation (OIC).

16 Mar 2011

Unigene initiates oral PTH Phase 2 study in postmenopausal women with osteoporosis

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today the dosing of the first subject in a Phase 2 study with an experimental oral parathyroid hormone analog for the treatment of osteoporosis in postmenopausal women.

16 Mar 2011

iTherX commences ITX-5061 Phase 1b study in patients with HCV

iTherX, a pharmaceutical company dedicated to discovering and developing a new class of therapies for hepatitis C, today announced that it has commenced patient recruitment in an open-label, proof-of-concept Phase 1b study of its lead compound ITX-5061 in liver transplant patients with hepatitis C virus infection.

16 Mar 2011

Incyte’s ruxolitinib COMFORT-II Phase III trial in MF meets primary endpoint

COMFORT-II, the second pivotal Phase III trial of Incyte Corporation's investigational Janus kinase inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis, when compared to best available therapy.

15 Mar 2011

Oxford Biomedica’s TroVax(R) TRIST Phase III study results to be published in Cancer Immunology, Immunotherapy

Oxford BioMedica plc, a leading gene therapy company, today announces that further analyses of the TroVax Renal Immunotherapy Survival Trial, a randomised, double-blind, placebo-controlled Phase III study, have been accepted for publication in Cancer Immunology, Immunotherapy, the official journal of the Association for Cancer Immunotherapy.

15 Mar 2011

Placebo News and Research

BioMarin announces preliminary results from ADAPT in patients suffering from PKU

KYTHERA presents additional data from third ATX-101 Phase II clinical study in submental fat reduction

New study: Men who consume hair loss drug may report sexual dysfunction

FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

Gene therapy for Parkinson’s: It works!

PsiOxus commences MT-102 Phase II study for treatment of cancer- and age-related wasting

New lozenge clinical trial for dry mouth treatment

New study: Positive outcomes from gene therapy trial in patients with Parkinson's

Gene therapy holds promise for Parkinson's treatment

New omalizumab medication may reduce seasonal asthma attacks in children

Results from first successful phase 2 trial of gene therapy for Parkinson's or any neurologic disorder

Fibrocell Science submits azficel-T final study report to FDA

RegeneRx RGN-352 Phase 2 trial in acute myocardial infarction placed on clinical hold

Cortex enters agreement with Biovail to regain AMPAKINE assets and rights

Montreal Heart Institute and Cerenis commence CER-001 Phase 2 study in acute coronary syndrome

AstraZeneca commences NKTR-118 Phase III clinical programme for opioid-induced constipation

Unigene initiates oral PTH Phase 2 study in postmenopausal women with osteoporosis

iTherX commences ITX-5061 Phase 1b study in patients with HCV

Incyte’s ruxolitinib COMFORT-II Phase III trial in MF meets primary endpoint

Oxford Biomedica’s TroVax(R) TRIST Phase III study results to be published in Cancer Immunology, Immunotherapy

Industry Focus eBook - Cell biology (5th edition) eBook

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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