ACAD
31.7
0.00
0.00%
AEMD
0.25
-0.02
-6.81%
APRI
1.22
0.00
0.00%
ARNA
4.77
0.00
0.00%
ATEC
1.32
0.00
0.00%
CFN
59.74
0.00
0.00%
CNAT
6.09
0.00
0.00%
CRXM
0.2
0.00
-0.01%
CYTX
0.5
0.00
0.00%
DXCM
62.32
0.00
0.00%
GNMK
13.51
0.00
0.00%
HALO
14.48
0.00
0.00%
ILMN
203.25
0.00
0.00%
INNV
0.2
-0.03
-11.16%
INO
8.94
0.00
0.00%
ISCO
0.06
0.00
0.00%
ISIS
72.4
0.00
0.00%
LGND
58.56
0.00
0.00%
LPTN
2.94
0.00
0.00%
MBVX
1.11
-0.06
-5.13%
MEIP
3.69
0.00
0.00%
MNOV
3.46
0.00
0.00%
MRTX
20.98
0.00
0.00%
MSTX
0.46
0.00
0.00%
NBIX
33.54
0.00
0.00%
NUVA
46.93
0.00
0.00%
ONCS
0.39
0.00
-0.88%
ONVO
6.59
0.00
0.00%
OREX
5.67
0.00
0.00%
OTIC
34.42
0.00
0.00%
QDEL
24.96
0.00
0.00%
RCPT
116.69
0.00
0.00%
RGLS
18.9
0.00
0.00%
RMD
65.2
0.00
0.00%
SCIE
0.01
0.00
0.00%
SPHS
0.49
0.00
0.00%
SRNE
10.62
0.00
0.00%
TROV
5.95
0.00
0.00%
VICL
1.03
0.00
0.00%
VOLC
17.97
0.00
0.00%
ZGNX
1.39
0.00
0.00%
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New Study Shows Urinary Levels Of Novel Biomarkers Measured By Astute Medical’s NephroCheck® Test Are Associated With Adverse Long-term Outcomes In Patients With Acute Kidney Injury

January 13, 2015 – 8:17 am | Edit Post
New Study Shows Urinary Levels Of Novel Biomarkers Measured By Astute Medical’s NephroCheck® Test Are Associated With Adverse Long-term Outcomes In Patients With Acute Kidney Injury

SAN DIEGO, Jan. 13, 2015 /PRNewswire/ — Citing a study recently published online in the Journal of the American Society of Nephrology (JASN), Astute Medical, Inc. Co-founder and Chief Scientific Officer Paul McPherson today said the Company’s investment in clinical studies continues to yield new information about the novel acute kidney injury (AKI) biomarkers measured by the NephroCheck® Test.

Investigators in the blinded, international, multi-center study found that the combination of the two biomarkers tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7) measured early in the setting of critical illness are associated with increased risk for mortality or receipt of renal replacement therapy over the next 9 months in patients with AKI. The combination of the two biomarkers remained significantly associated with the composite endpoint after accounting for serum creatinine, a common lab test that measures kidney function.[1]

Investigators also found that the risk of dialysis or death increased with higher levels of the biomarker combination.[1]

The authors noted in the publication that the results suggest that the association of the biomarkers of acute kidney distress and long-term adverse outcomes is caused by important underlying renal biology.[1]

The Company-sponsored study enrolled 744 critically ill patients, with 52 excluded from the analyses, at 35 medical centers in North America and Europe. Patients were tested within the first day of admission to the intensive care unit. The combination of TIMP-2 and IGFBP-7 was measured with Astute Medical’s NephroCheck® Test.[1]

The NephroCheck® Test was cleared through the FDA’s de novo classification process in September 2014 and is CE-marked in Europe. In the United States the NephroCheck® Test is only cleared for use in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are intensive care unit (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. This clearance does not include use of the NephroCheck® Test for the type of patient assessment performed in the study reported in the JASN article.

To facilitate marketing of the NephroCheck® Test in the United States and Europe, in July 2014, Astute designated Ortho-Clinical Diagnostics, Inc. (OCD) as the exclusive sales agent for Astute’s NephroCheck® Test and Astute140® Meter in certain countries of the European Union and the United States. Astute has also granted OCD a semi-exclusive worldwide license to develop and commercialize a version of the NephroCheck® Test for use on its VITROS® line of automated, high-volume testing platforms. The test developed for the OCD platform will require separate regulatory clearances before it can be sold.

AKI, an emerging global health threat, is a common, costly and potentially deadly complication in hospitalized patients.[2] Traditional methods of risk assessment are insufficient placing substantial numbers of patients at serious risk of complications and death.[3],[4] AKI may affect up to 50 percent of critically ill hospitalized patients.[5]

Astute Medical, Inc., Astute Medical®, the AM logo, Astute140®, NephroCheck® and the NephroCheck® logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRisk™ is a trademark of Astute Medical, Inc. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/US/About/IntellectualProperty. PN 0417 Rev A 2015/01/12

[1] Koyner JL, Shaw AD et al. Tissue Inhibitor Metalloproteinase-2 (TIMP-2)·IGF-Binding Protein-7 (IGFBP7) Levels Are Associated with Adverse Long-Term Outcomes in Patients with AKI. J Am Soc Nephrol 26:xx xx 2014. Published online ahead of print.
[2] Lewington AJP, Certa J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney Int. 2013;84(3):457-467.
[3] Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter.,Suppl. 2012; 3:1-150.
[4] MacLeod A. NCEPOD report on acute kidney injury – must do better. Lancet. 2009;374:1405-6.
[5] Mandelbaum T, Scott D, Lee J, et al. Outcome of Critically Ill Patients with Acute Kidney Injury Using the AKIN Criteria. Crit Care Med. 2011;39(12):2659–2664.

 

SOURCE Astute Medical, Inc.

Cord Blood Registry and Cellular Dynamics International Announce Collaboration to Reprogram Newborn Stem Cells into Induced Pluripotent Stem Cells

January 13, 2015 – 7:02 am | Edit Post
Cord Blood Registry and Cellular Dynamics International Announce Collaboration to Reprogram Newborn Stem Cells into Induced Pluripotent Stem Cells

SAN BRUNO, Calif. and MADISON, Wis., Jan. 13, 2015 /PRNewswire/ — Cord Blood Registry® (CBR®) and Cellular Dynamics International (NASDAQ: ICEL) (CDI) announced today that they have entered into a research collaboration to reprogram newborn stem cells from both umbilical cord blood and umbilical cord tissue collected, processed and cryopreserved under CBR’s protocols into induced pluripotent stem cells (iPSCs) using CDI’s proprietary methods. 

Through this research collaboration, CBR will provide to CDI multiple de-identified, research-donated and cryopreserved umbilical cord blood units as well as multiple de-identified units of mesenchymal stem cells (MSCs) isolated from previously cryopreserved cord tissue. CDI will reprogram the cells into iPSCs and confirm their pluripotent nature.

iPSCs, cells that have the ability to replicate indefinitely and to differentiate into any cell type in the human body, are one of the most promising frontiers in human medicine. Once an iPSC line is created, it becomes a renewable source of starting material for differentiation into any tissue of the body. iPSCs are currently used by researchers in disease modeling, drug screening and in the early stages of cell-based therapy clinical trials. A patient-specific iPSC line would have significant potential in future cell therapies as any tissue differentiated from those iPSCs would be a perfect genetic match to the individual from whose cells the original line was created.

Hematopoietic stem cells (HSCs), like those found in umbilical cord blood, and MSCs, like those found in cord tissue, have previously been shown by researchers to be reprogrammable into iPSCs (Mack, 2011 and Cai, 2010). However, this research collaboration will be unique in that a leader in iPSC technology and the world’s largest cord blood bank have partnered to establish a workflow to allow HSCs and MSCs collected and cryopreserved at birth by CBR to be later reprogrammed into iPSCs for individuals. 

“CBR is excited to enter into this research collaboration with CDI, a leader in iPSC technology,” said Geoffrey Crouse, President and CEO of CBR. “Establishing a repeatable process, by which CBR’s clients can have their newborn stem cells reprogrammed to become induced pluripotent stem cells, has the potential to increase the future utility of the cells we store in our bank. The stem cells our clients have stored are particularly unique as a starting material as they are collected at birth and typically undamaged by age, disease and environmental factors that may be encountered through life.”

“We look forward to applying CDI’s proprietary episomal reprogramming technique to create iPSCs from cells stored in CBR’s bank,” said Bob Palay, Chairman and CEO of CDI. “Our goal is for the families who have entrusted CBR to store newborn stem cells from more than 500,000 children to know that they can have CDI establish a line of individualized iPSCs that matches their own genetic material. Given the rate of clinical advancements in iPSCs and their capacity to differentiate into different tissues, the ability to create a pluripotent stem cell from newborn stem cells has the potential to become a very valuable resource to treat disease.”

About Cord Blood Registry
Cord Blood Registry® (CBR®) is the world’s largest newborn stem cell company. Founded in 1994, CBR is entrusted by parents with storing more than 500,000 cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with leading research institutions to establish FDA-regulated clinical trials, for conditions that have no cure today. For more information, visit cordblood.com.

About Cellular Dynamics, Inc.
Cellular Dynamics International, Inc. is a leading developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications. CDI’s proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell Products). CDI’s iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in the research and development of cellular therapeutics. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI’s facilities are located in Madison, Wisconsin, with a second facility in Novato, California. See www.cellulardynamics.com.

Forward-looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Cellular Dynamics International, Inc., including statements regarding the reprogramming of iPSCs from newborn stem cells and their potential value for treatment of disease, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our product development efforts, actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Cellular Dynamics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Cellular Dynamics’ Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on March 11, 2014, which risks are incorporated herein by reference, and as may be described from time to time in Cellular Dynamics’ subsequent SEC filings.

References:
Mack AA, Kroboth S, Rajesh D, Wang WB. Generation of Induced Pluripotent Stem Cells from CD34+ Cells across Blood Drawn from Multiple Donors with Non-Integrating Episomal Vectors. PLoS ONE 2011;6(11): e27956.
Cai J, Li W, Su H, et al. Generation of Human Induced Pluripotent Stem Cells from Umbilical Cord Matrix and Amniotic Membrane Mesenchymal Cells. J. Biol Chem. 2010;285(15)11227-11234.

Logo – http://photos.prnewswire.com/prnh/20150112/168704LOGO

Logo – http://photos.prnewswire.com/prnh/20150112/168705LOGO

 

SOURCE Cord Blood Registry; Cellular Dynamics, Inc.

Vista Partners Initiates Coverage on OncoSec Medical (Ticker: ONCS); Price Target $1.20

January 13, 2015 – 7:00 am | Edit Post

Vista Partners Initiates Coverage on OncoSec Medical (Ticker: ONCS); Price Target $1.20

Vista Partners Initiates Coverage on OncoSec Medical (Ticker: ONCS); Price Target $1.20

January 13, 2015 – 7:00 am | Edit Post

Vista Partners Initiates Coverage on OncoSec Medical (Ticker: ONCS); Price Target $1.20

Qualcomm Ventures Forms Joint Investment Business with Novartis

January 12, 2015 – 5:33 pm | Edit Post
Qualcomm Ventures Forms Joint Investment Business with Novartis

Qualcomm (NASDAQ: QCOM), the San Diego wireless technologies giant, plans to form a joint investment business through its corporate ventures arm with the Swiss pharmaceutical giant Novartis. The…

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Qualcomm Ventures Forms Joint Investment Business with Novartis

January 12, 2015 – 5:33 pm | Edit Post

Qualcomm (NASDAQ: QCOM), the San Diego wireless technologies giant, plans to form a joint investment business through its corporate ventures arm with the Swiss pharmaceutical giant Novartis. The…

[[Click headline to continue reading.]]

Qualcomm Ventures Forms Joint Investment Business with Novartis

January 12, 2015 – 5:33 pm | Edit Post

Qualcomm (NASDAQ: QCOM), the San Diego wireless technologies giant, plans to form a joint investment business through its corporate ventures arm with the Swiss pharmaceutical giant Novartis. The…

[[Click headline to continue reading.]]

Qualcomm Ventures Forms Joint Investment Business with Novartis

January 12, 2015 – 5:33 pm | Edit Post

Qualcomm (NASDAQ: QCOM), the San Diego wireless technologies giant, plans to form a joint investment business through its corporate ventures arm with the Swiss pharmaceutical giant Novartis. The…

[[Click headline to continue reading.]]

Evofem, Inc. Announces Pre-NDA Meeting With FDA For Amphora

January 12, 2015 – 5:00 pm | Edit Post

SAN DIEGO, Jan. 13, 2015 (GLOBE NEWSWIRE) — Evofem, Inc., a biotechnology company focused on the discovery and development of women’s health products, announced today that it concluded its pre-New Drug Application (NDA) meeting with the U.S. Food and …

Thermo Fisher Scientific Launches Ion Torrent AmpliSeq RNA Fusion Lung Cancer Research Panel

January 12, 2015 – 5:00 pm | Edit Post

CARLSBAD, Calif.–(BUSINESS WIRE)–Today Thermo Fisher Scientific announced that it has released a next-generation sequencing (NGS) RNA panel and workflow that enables targeted sequencing of fusion transcripts for clinical research. The new Ion Torrent…