Saturday, November 22, 2014

Knight sells priority review voucher for $125-million

Knight sells priority review voucher for $125-million

November 19, 2014 by · Leave a Comment 

Tweet Knight Therapeutics (TSX:GUD) has sold its neglected tropical disease priority review voucher (PRV) to Gilead Sciences for $125-million. “We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity,” Jonathan Goodman, president and CEO of […]

Tandem takes consumer device approach to insulin pumps

Tandem takes consumer device approach to insulin pumps

November 18, 2014 by · Leave a Comment 

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Tweet Tandem Diabetes (NASDAQ:TNDM), which now markets the popular t:slim Insulin Pump for people with Type 1 diabetes and has two new pumps awaiting FDA clearance, has taken a unique consumer-focused approach to the design of its products. “When we started the company, we had to figure out why only 27% of people with Type […]

rEVO Biologics spearheading preeclampsia treatment

rEVO Biologics spearheading preeclampsia treatment

November 11, 2014 by · Leave a Comment 

Tweet Closely held rEVO Biologics is enrolling patients in a Phase 3 clinical trial of its ATryn recombinant human antithrombin for the treatment of early-onset preeclampsia, with top-line data expected in the second quarter of 2016. “This is a potentially life threatening disorder of pregnancy and a devastating unmet medical need,” Yann Echelard, president and […]

Aeterna Zentaris gets CRL on Macrilen

Aeterna Zentaris gets CRL on Macrilen

November 6, 2014 by · Leave a Comment 

Tweet Aeterna Zentaris (NASDAQ:AEZS; TSX:AEZ) has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form. The CRL said […]

AD focus shifts to treating agitation/aggression

AD focus shifts to treating agitation/aggression

October 28, 2014 by · Leave a Comment 

Tweet After years of fruitless search for new therapies to slow the deadly progression of Alzheimer’s disease (AD), researchers are having more success with experimental treatments for the neuropsychiatric symptoms associated with AD, such as agitation and aggression. A case in point is Avanir Pharmaceuticals (NASDAQ:AVNR), which reported positive results in mid-September from a Phase […]

Analysts launch coverage of Tokai Pharma

Analysts launch coverage of Tokai Pharma

October 13, 2014 by · Leave a Comment 

Tweet Analysts at William Blair, Stifel and Janney Capital Markets initiated coverage of Tokai Pharmaceuticals (NASDAQ:TKAI), saying its lead asset, galeterone, represents a first-in-class and best-in-class, selective and multi-targeted small molecule that should offer advantages over existing prostate cancer therapies. Analyst Katherine Xu started Tokai at “outperform” with a $44 price target. Shares of Tokai […]

Jefferies starts ReWalk Robotics at buy

Jefferies starts ReWalk Robotics at buy

October 7, 2014 by · Leave a Comment 

Tweet Jefferies has initiated coverage of ReWalk Robotics (NASDAQ:RWLK) with a “buy” rating and price target of $39. The stock closed at $29.20 on Monday. ReWalk is a leader in the development and commercialization of robotic Exoskeletons, mechanical devices that aid in mobility and other physical functions, allowing spinal cord injured patients to stand and walk. “With […]

Verisante begins FDA approval process for Aura

Verisante begins FDA approval process for Aura

October 1, 2014 by · Leave a Comment 

Tweet Verisante Technology (OTCQX:VRSEF; TSX-V:VRS) has initiated communications with the FDA for the approval of Aura, a device for the detection of skin cancer. “Verisante has now submitted documents to the FDA as we begin the formal application process for approval to market and sell Aura in the U.S.,” president and CEO, Thomas Braun, said […]

Amarantus requests pre-IND feedback from FDA

Amarantus requests pre-IND feedback from FDA

September 29, 2014 by · Leave a Comment 

Tweet Amarantus Bioscience Holdings (OTCQB:AMBS) has submitted a request to the FDA for a review and written feedback of the Phase 2b clinical trial design for Eltoprazine in levodopa-induced dyskinesia (LID), a common side effect of levodopa treatment in Parkinson’s disease patients. ”We are very pleased to have submitted this pre-IND review request letter to […]

Mackie Research starts Medicure at buy

Mackie Research starts Medicure at buy

September 26, 2014 by · Leave a Comment 

Tweet Mackie Research has initiated coverage of Medicure (TSX-V:MPH) with a “buy” recommendation and 12-month target price of $2.80. The stock was quoted at $2.10 on Friday morning. “The FDA approval of Aggrastat HDB in October 2013 and its launch should be the driver of sales and earnings,” writes analyst Andre Uddin. He expects revenue […]

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