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FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).

4 Jan 2011

PanOptica completes $30 million Series A financing

PanOptica, Inc., a private biopharmaceutical company focused on licensing and developing innovative ophthalmology therapies, today announced that it has raised $30 million in a Series A financing. This round was led by SV Life Sciences and Third Rock Ventures.

4 Jan 2011

Encouraging results from exon skipping gene-based therapy study for DMD

Scientists at Royal Holloway, University of London have reported encouraging results in a new gene-based therapy for Duchenne Muscular dystrophy (DMD) which at present has no known cure and affects one in 3,000 young boys.

4 Jan 2011

The Scientist examines how nonprofit, for-profit pharma groups are working together to make drugs more affordable for developing countries

"With philanthropists funneling billions of dollars into biomedical research and traditional drug discovery efforts producing fewer and fewer therapies, the line between for-profit and nonprofit life science companies is beginning to blur as both sides of the divide look for new options," The Scientist magazine writes in an article that examines the rise in collaborations between nonprofit pharmaceutical companies and for-profit groups.

4 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

30 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study.

29 Dec 2010

FDA stops pain drug trial over safety concerns

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

29 Dec 2010

Experimental device for obstructive sleep apnea

Obstructive sleep apnea, a dangerous sleep disorder that affects millions of Americans may have found a cure. The disease commonly manifested as snoring but leading to tremendous sleep deprivation can be severely debilitating. Sleep deprivation may lead to car crashes, accidents, high blood pressure, heart attack, stroke, and diabetes.

29 Dec 2010

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 Dec 2010

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

HeartWare International, Inc. today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

28 Dec 2010

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Emergent BioSolutions today announced the initiation of a Phase I clinical trial for NuThraxTM, also known as AV7909, with the dosing of the first subject.

27 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

Vitamin D levels of newborns appear to predict their risk of respiratory infections

The vitamin D levels of newborn babies appear to predict their risk of respiratory infections during infancy and the occurrence of wheezing during early childhood, but not the risk of developing asthma. Results of a study in the January 2011 issue of Pediatrics support the theory that widespread vitamin D deficiency contributes to risk of infections.

27 Dec 2010

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

Study investigators reported positive steps in Cook Medical's efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection for purposes of seeking FDA approval. The findings were presented by Dr. Joseph Lombardi at the 37th annual VEITHsymposium.

23 Dec 2010

AADR testifies at FDA Advisory Panel meeting on dental amalgam

On December 14-15, 2010, the U.S. Food and Drug Administration (FDA) convened an Advisory Panel to discuss several scientific issues that may affect the regulation of dental amalgam. At the conclusion of the hearing, the Panel voted to recommend that the FDA conduct further review of the material's safety.

23 Dec 2010

Clinical Trial News and Research

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

PanOptica completes $30 million Series A financing

Encouraging results from exon skipping gene-based therapy study for DMD

The Scientist examines how nonprofit, for-profit pharma groups are working together to make drugs more affordable for developing countries

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

FDA approves Endo's FORTESTA Gel for low testosterone

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

FDA stops pain drug trial over safety concerns

Experimental device for obstructive sleep apnea

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Vitamin D levels of newborns appear to predict their risk of respiratory infections

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

AADR testifies at FDA Advisory Panel meeting on dental amalgam

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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