Thursday, April 24, 2014

In conversation with Tony Pullen

In conversation with Tony Pullen

April 1, 2014 by · Leave a Comment 

Tweet Tony Pullen is one of the deans of Canadian capital markets. His career in biotech traces its roots to 1985 as an advisor to Cangene, which merged with Emergent BioSolutions (NYSE:EBS) in February. He also was instrumental in raising the initial capital for MDS Health Ventures, which went on to become MDS Capital Corp., […]

Venaxis files for FDA approval of APPY1

Venaxis files for FDA approval of APPY1

March 31, 2014 by · Leave a Comment 

Tweet Venaxis (NASDAQ:APPY) has filed a 510(k) premarket submission to market its APPY1 Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis. The test is already CE Marked in Europe. “We are highly encouraged by the positive results from our pivotal clinical study, and I would like […]

MRI Interventions’ ClearPoint changing brain surgery paradigm

MRI Interventions’ ClearPoint changing brain surgery paradigm

March 25, 2014 by · Leave a Comment 

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Tweet “Our goal is to transform the way brain surgery is performed to advance better treatment options for patients for whom current therapies are deficient.” So says Kimble Jenkins, CEO of MRI Interventions (OTCQB:MRIC), referring to the company’s ClearPoint surgical platform that provides real-time visualization via magnetic resonance image (MRI) guidance for a range of minimally […]

Venaxis posts positive pivotal results from APPY1

Venaxis posts positive pivotal results from APPY1

March 13, 2014 by · Leave a Comment 

Tweet Venaxis (NASDAQ:APPY) has announced positive top-line results from its pivotal U.S. study. The APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from a previous 500-patient pilot study. The company believes the pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k) submission and file with […]

Alpha Cancer to test oncology game changer

Alpha Cancer to test oncology game changer

March 11, 2014 by · Leave a Comment 

http://www.youtube.com/watch?v=HJr8cGE2eVs’]

Tweet Closely held Alpha Cancer Technologies, which is going public in a reverse takeover of Bradmer Pharmaceuticals (TSX-V:BMR-H), plans to begin testing patients with ovarian cancer this year with its drug candidate, ACT-901, which features a novel targeted drug delivery platform. BioTuesdays.com had an opportunity to interview the company’s founder & CEO, Dr. Igor Sherman, […]

Roth starts Durata Therapeutics at buy

Roth starts Durata Therapeutics at buy

March 6, 2014 by · Leave a Comment 

Tweet Roth Capital Partners has initiated coverage of Durata Therapeutics (NASDAQ:DRTX) with a “buy” rating and $20 price target. The stock was quoted at $14.09 on Thursday afternoon. “We believe that Dalvance, a novel, once-weekly, two-dose antibiotic, is best positioned among new drug candidates to treat the rising threat of antibiotic resistance from ‘super bugs’, including […]

Gamida Cell shifts focus to NiCord stem cell product

Gamida Cell shifts focus to NiCord stem cell product

March 4, 2014 by · Leave a Comment 

Tweet Closely held Gamida Cell has shifted its focus to its second-generation stem cell product, NiCord, for the treatment of hematological malignancies and non-malignant hematological diseases in the wake of an FDA decision last year for another pivotal trial of its first stem cell product, StemEx. “We view the clinical outcomes with NiCord as a […]

DARA’s KRN5500 gets orphan drug designation

DARA’s KRN5500 gets orphan drug designation

February 25, 2014 by · Leave a Comment 

Tweet The FDA granted orphan drug designation to DARA BioSciences’ (NASDAQ:DARA) KRN5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics. DARA’s non-opioid, non-narcotic intravenous product is currently in Phase 2 clinical development. “KRN5500, is a candidate to treat chronic neuropathic pain induced by chemotherapy, and fits perfectly […]

Advaxis readies cervical cancer pivotal trial

Advaxis readies cervical cancer pivotal trial

February 25, 2014 by · Leave a Comment 

Tweet Advaxis (NASDAQ:ADXS) hopes to begin a registration trial before the end of the year with its next-generation immunotherapy, ADXS-HPV, for the treatment of invasive cervical cancer. “We are pleased with the encouraging results of our Phase 2 study, which supports a continuing path towards registration for our lead product candidate,” CEO Daniel O’Connor says […]

Leerink ups Intra-Cellular target to $34 from $13

Leerink ups Intra-Cellular target to $34 from $13

February 10, 2014 by · Leave a Comment 

Tweet Leerink Partners has raised its price target for “outperform-rated” Intra-Cellular Therapies (NASDAQ:ITCI) to $34 from $13, after making adjustments to the revenue and expense lines in its model, which was originally very conservative. The stock closed at $16.80 on Friday. “We are making changes to our previous 2014-2016 expense estimates, which already covered funding […]

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