Tuesday, January 27, 2015

Actinium submits pre-IND meeting request to FDA

Actinium submits pre-IND meeting request to FDA

January 26, 2015 by · Leave a Comment 

Tweet Actinium Pharmaceuticals (NYSE MKT:ATNM) has submitted a request for a pre-IND meeting to the FDA for the company’s Iomab-B drug candidate currently undergoing final preparations to start a pivotal Phase 3 trial in mid-2015. The initial indication for Iomab-B is conditioning for bone marrow transplant in older relapsed and refractory acute myeloid leukemia patients, […]

EndyMed expands sales effort in U.S.

EndyMed expands sales effort in U.S.

January 20, 2015 by · Leave a Comment 

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Tweet After five years of selling its skin rejuvenation devices to medical professionals through a distributor, EndyMed Medical (TASE:ENDY) has launched a U.S.-based direct sales operation through subsidiary, EndyMed USA. “During the second half of 2014, we expanded the sales force team to cover all major markets in the U.S. and significantly increased our U.S.-based […]

Roth ups Cytori price target to $6

Roth ups Cytori price target to $6

January 16, 2015 by · Leave a Comment 

Tweet Roth Capital Partners has raised its price target for “buy-rated” Cytori Therapeutics (NASDAQ:CYTX) to $6 from $3.50 after attending a key opinion leaders event with Dr. Dinesh Khanna, who will be the principal investigator in the upcoming Phase 3 STAR study for scleroderma with hand dysfunction. Shares of Cytori closed at 44 cents on […]

Harvard Apparatus to file IND for regenerated trachea trial

Harvard Apparatus to file IND for regenerated trachea trial

January 13, 2015 by · Leave a Comment 

Tweet Harvard Apparatus Regenerative Technology (NASDAQ:HART) plans to file an IND later this year for a pivotal trial of the world’s first regenerated trachea transplant in patients facing life-threatening trachea trauma and cancer. “Our InBreathAirway Transplant System has been successful in six human compassionate cases and because we have great data from these cases, we […]

Vital Therapies provides clinical and regulatory update

Vital Therapies provides clinical and regulatory update

January 12, 2015 by · Leave a Comment 

Tweet Vital Therapies (NASDAQ:VTL) has provided an update on its clinical trial programs and regulatory matters. Currently, 193 of a targeted 200 subjects have been enrolled in VTI-208, the company’s Phase 3 clinical trial in alcohol induced liver decompensation. Forty-six clinical sites are now open in the U.S., UK, Spain and Australia. The Company expects […]

Gamida’s NiCord gets FDA, EMA orphan drug status

Gamida’s NiCord gets FDA, EMA orphan drug status

January 6, 2015 by · Leave a Comment 

Tweet Closely-held Gamida Cell’s NiCord cell therapy for the treatment of acute lymphoblastic leukemia, acute myeloid leukemia (AML), Hodgkin lymphoma and myelodysplastic syndrome has received orphan drug designation from the FDA. The FDA orphan drug designation coincides with the positive opinion of the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products regarding NiCord as […]

Amarantus gets orphan drug approval for MANF

Amarantus gets orphan drug approval for MANF

December 24, 2014 by · Leave a Comment 

Tweet The FDA has granted Amarantus BioScience Holdings’ (OTCQB:AMBS) investigational drug MANF (mesencephalic-astrocyte-derived neurotrophic factor) orphan drug designation for the treatment of retinitis pigmentosa (RP), a group of inherited diseases causing retinal degeneration often leading to blindness. Preclinical data showed that MANF provided protective functional effects in an animal model of RP. Toxicology studies also […]

Amarantus in second closing of Series E preferred

Amarantus in second closing of Series E preferred

December 19, 2014 by · Leave a Comment 

Tweet Amarantus BioScience Holdings (OTCQB:AMBS) has entered into definitive agreements to raise an additional $2-million under its previously announced transaction to issue Series E preferred stock, bringing the total capital raised to $5-million. “In recent months, we have been working towards further strengthening our balance sheet, and I am very pleased to have the ability […]

Medifocus receives two Canadian patents

Medifocus receives two Canadian patents

December 15, 2014 by · Leave a Comment 

Tweet Medifocus (OTCQX:MDFZF; TSX-V:MFS) has obtained two newly allowed Canadian patents covering its platform technology for the treatment of breast cancer. The titles of the patents are “Thermotherapy Method for Treatment and Prevention of Breast Cancer” and the “Method for Improved Safety in Externally Focused Microwave Thermotherapy for Treating Breast Cancer.” A major embodiment of […]

Cantor upgrades Sunesis Pharma to buy

Cantor upgrades Sunesis Pharma to buy

December 10, 2014 by · Leave a Comment 

Tweet Cantor Fitzgerald has upgraded Sunesis Pharmaceuticals (NASDAQ:SNSS) to “buy” and raised its price target to $4 from $2 ahead of an FDA meeting in early 2015. The stock closed at $2.31 on Tuesday. “With the full VALOR dataset now in the public domain (presented as an ASH late-breaker on Dec. 9), we think expectations […]

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