Tag Archives: IND

Linux

Text qualifier issue causing data alignment problem

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By AnkitSenghani

Hello Everyone,

I have a csv file with text qualifier as “” and data similar to below:

“1”,”abc”,”address1″,”US“
“2”,”def”,”address1 “characters in double-quote” address2″,”IND“
“3”,”ghi”,”address1″,”UK”

In above example, for record 2, we have an issue as in column3 contains double quotes within double quotes. Its causing issue in reading file and data is getting wrongly alligned for that particular record.

Is there a way to use awk or sed so that we can find the record with above issue and reject them to create a new file having only good records.

From: http://www.unix.com/shell-programming-scripting/221597-text-qualifier-issue-causing-data-alignment-problem.html

Linux

Two files comparision with single field

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By shivaji_veer

Hi ,

Im new to uxin environment and shell scripting….

please help me with the code for the following scenario…..

file 1 contains the following fields

abc 200 rupee IND
cdf 400 dollar USA
efg 300 euro GER
hij 600 pound ENG

file 2
SBI abc 321 dollar CANAD
kvr mnd 345 pound FRANC
axs efg 879 euro Russia

if field 1 of file1 matches field 2 of file2 then complete row of filed2 in file should be displayed.

output file:

SBI abc 321 dollar CANAD
axs efg 879 euro Russia

Can someone help on this ….

Source: FULL ARTICLE at The UNIX and Linux Forums

Business, Finance, Occupation & Industry

BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatmen

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By Business Wirevia The Motley Fool

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BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatment of Leukemia


Partial results expected in Q4 2013


Final results expected in H2 2014

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that it has received all necessary regulatory approvals in the US to commence a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML).

The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed/refractory AML. The primary endpoints of the study are the safety and tolerability of the drug. Secondary endpoints will include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy. The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death. The study is expected to be conducted in the U.S. and Israel, and will enroll up to 50 patients.

“This program is generating a lot of enthusiasm from our clinical research partners, and we are very pleased that several renowned and respected investigators will be leading our study in the U.S. and Israel,” said Kinneret Savitsky, PhD, CEO of BioLineRx. “AML is one of the most common types of leukemia in adults, yet survival rates continue to be low relative to other leukemias. In particular, treatment options for patients with relapsed or refractory AML are extremely limited, and in many cases, only palliative care is offered. We look forward to the partial results expected towards the end of this year, and have sincere hopes that BL-8040 will be a significant and efficient addition in the battle with this devastating disease.”

“We are honored to collaborate with BioLineRx on this exciting project,” said Dr. Gautam Borthakur, the principal investigator of the trial at the MD Anderson Cancer Center …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Why Regulus Therapeutics Is Poised to Keep Plunging

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By Brian D. Pacampara, The Motley Fool

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Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool’s free investing community, biopharmaceutical company Regulus Therapeutics has received the dreaded one-star ranking.

With that in mind, let’s take a closer look at Regulus and see what CAPS investors are saying about the stock right now.

Regulus facts

Headquarters (founded)

San Diego, Calif. (2007)

Market Cap

$1 billion

Industry

Biotechnology

Trailing-12-Month Revenue

$12.7 million

Management

CEO Dr. Kleanthis Xanthopoulos (since 2009)
COO Dr. Garry Menzel (since 2009)

Trailing-12-Month Return on Equity

(55%)

Cash/Debt

$98.1 million / $10.1 million

Sources: S&P Capital IQ and Motley Fool CAPS.

On CAPS, 85% of the 13 members who have rated Regulus believe the stock will underperform the S&P 500 going forward.

Just yesterday, one of those Fools, All-Star zzlangerhans, succinctly summed up the Regulus bear case for our community:

They have an enterprise value of [$150M] and all they have to justify it is their [Isis Pharmaceuticals/Alnylam Pharmaceuticals] pedigree. They won’t be submitting an IND for their first microRNA therapeutic until 2014, and their existing partnerships don’t provide much income. What concerns me the most is that their lead compound is an intravenous therapy for Hepatitis C. Where has management been for the last five years, as other companies have been demonstrating high rates of cure with all-oral regimens? The company now admits they will only be able to target a niche population that has failed other therapies. If that’s the best we can hope for from microRNA, I’ll stick with RNAi.

While you can certainly make quick gains in speculative biotechs like Regulus, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool’s free report “3 Stocks That Will Help You Retire Rich” names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.

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The article Why Regulus Therapeutics Is Poised to Keep Plunging originally appeared on Fool.com.

Fool contributor Brian Pacampara has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

…read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Rexahn Pharmaceuticals to Present data on the Mechanism of action of RX-5902: A first-in-class inhib

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By Business Wirevia The Motley Fool

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Rexahn Pharmaceuticals to Present data on the Mechanism of action of RX-5902: A first-in-class inhibitor of p68 helicase for the treatment of solid tumors at AACR Annual Meeting 2013

ROCKVILLE, Md.–(BUSINESS WIRE)– Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company developing potential best-in-class oncology therapies, today announced that it will present mechanism of action data on RX-5902 during a poster session at the American Association for Cancer Research (AACR) 104th Annual Meeting being held in Washington, DC, April 6-10, 2013, at the Washington Convention Center.

The Company will present the mechanism data of RX-5902 in a poster (abstract #5507) entitled, “Mechanistic study of a new 4-(3, 5-dimethoxyphenyl)-N-(7-fluoro-3-methoxyquinoxalin-2-yl)piperazine-1-carboxamide compound (RX-5902),” on Wednesday, April 10, 2013, during the “Chemotherapy and Cancer Dependencies” poster session from 8:00 am – 12:00 pm EDT in Exhibit Hall A-C, Poster Section 37.

For more information on the AACR conference, please visit www.aacr.org.

About RX-5902

RX-5902 is an orally bioavailable, first-in-class inhibitor of p68 RNA helicase for the treatment of various solid tumors, such as melanoma and cancers of the ovary, kidney and pancreas. Rexahn has filed an IND for RX-5902 and anticipates initiating Phase I clinical development in the second quarter of 2013.

RX-5902 has been shown to produce potent anti-tumor effects, increased survival in xenograft models, anti-proliferative activity in drug-resistance cancer cell lines and synergistic effects with known anti-cancer drugs.

RX-5902 is part of a growing pipeline of clinical stage oncology compounds that Rexahn is developing to potentially provide improved efficacy and reduced toxicity, resulting in improved survival and quality of life for patients.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and RX-5902 and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.

Safe Harbor

To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Amarantus BioScience Reports Positive MANF Data in Neuroprotection Animal Models of Parkinson's Dise

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By Business Wirevia The Motley Fool

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Amarantus BioScience Reports Positive MANF Data in Neuroprotection Animal Models of Parkinson’s Disease

Company’s proprietary therapeutic appears to protect key dopamine-producing brain function

SUNNYVALE, Calif.–(BUSINESS WIRE)– Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today reported positive preclinical data for its lead therapeutic MANF in neuroprotection 6-hydroxydopamine (6-OHDA) rat models of Parkinson’s disease. The data show that MANF protects the integrity of dopamine producing neurites in the striatum.

“Our scientists are excited by this data, which not only demonstrates the efficacy of MANF, but its superiority to GDNF, as well,” said Gerald E. Commissiong, President and Chief Executive Officer of Amarantus BioScience. “Based on this study, we believe MANF plays a role in maintaining brain connectivity, specifically the dopaminergic system of the basal ganglia network, which reinforces the potential of MANF as a disease-modifying treatment for Parkinson’s.”

In the neuroprotection study, MANF was delivered into the substantia nigra shortly before injection of the toxin 6-OHDA into the striatum. Four weeks later the animals were sacrificed and the density of dopaminergic neuron projections in the striatum was determined. The protection of neuron health, as measured by the density of neurite terminals, was evident in all three areas of the striatum examined. The effects of a single MANF treatment were evident after four weeks, indicating the effects of MANF protection are sustained. Furthermore, the highest level of neurite density was found at the highest dosage of MANF. Importantly, the neurite density measured under treatment with MANF was statistically significantly better than shown for both vehicle control and a standard dosage of Glial cell-Derived Neurotrophic Factor (GDNF). GDNF is currently in clinical trials for Parkinson’s disease and considered the current benchmark in the field. The data summarized here suggests that MANF may have advantages over GDNF for the clinical treatment of Parkinson’s disease.

“The data on MANF continues to return more favorable results than other molecules currently in clinical development as disease-modifying treatments for Parkinson’s disease,” said Dr. Joseph Rubinfeld, Amgen co-founder and current member of the Company’s Board of Advisors. “We intend to conduct select additional experiments to understand why this appears to be the case while we continue the IND-enabling studies that have already been initiated. We believe these additional data points will further distinguish MANF from competitors in the field, and will deliver significant value in the near-term.”

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Verastem Reports Year-End 2012 Financial Results

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By Business Wirevia The Motley Fool

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Verastem Reports Year-End 2012 Financial Results

–Advancing Clinical Development Programs Targeting Cancer Stem Cells through FAK and PI3K/mTOR Inhibition–

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Verastem, Inc., (NAS: VSTM) , a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported financial results for the year ended December 31, 2012, and also commented on corporate accomplishments and plans.

“Verastem achieved important milestones in our mission to bring new therapies targeting cancer stem cells to patients during 2012,” said Christoph Westphal, M.D., Ph.D., Chairman and Chief Executive Officer of Verastem. “We have built a strong foundation to translate the groundbreaking work of Bob Weinberg to clinical practice. In addition to our ongoing combination study in ovarian cancer, we are on track to initiate a potentially pivotal study of VS-6063 in mesothelioma.”

“The Phase 1/1b trial of lead FAK inhibitor, VS-6063, in combination with paclitaxel for patients with ovarian cancer is open and enrolling at all sites,” said Dr. Joanna Horobin, Chief Medical Officer of Verastem. “In addition to the potential benefit in ovarian cancer, the results from this trial may allow us to expand into additional tumor types where the combined use of a cancer stem cell inhibitor with the commonly used paclitaxel may be a more effective treatment.”

Verastem plans to initiate a potentially pivotal trial of VS-6063 in mesothelioma midyear 2013. Mesothelioma is a highly aggressive disease with an approximate median overall survival of just 12 months from diagnosis of advanced disease. Verastem studies have demonstrated that FAK inhibitors strongly reduce cancer stem cells in preclinical models of mesothelioma. In addition, in a recent third party Phase 1 clinical study of a FAK inhibitor, the median progression-free survival for patients with recurrent mesothelioma was tripled as compared to the reported historical median time to progression on placebo.

“We will continue to expand our FAK franchise in 2013 with a Phase 1 trial of VS-4718, our second FAK inhibitor, in advanced cancers, which is expected to commence in the first half of this year,” continued Dr. Horobin. “In addition, we are conducting IND-enabling studies to support the entry of our PI3K/mTOR inhibitor, VS-5584, into a Phase 1 trial during the second half of the year.”

“During 2012, Verastem secured firm financial footing with our initial public offering and accelerated our programs targeting cancer stem cells through translational research …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

NanoViricides President Dr. Diwan Invited to Present a Seminar at the Center for Biological Physics

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By Business Wirevia The Motley Fool

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NanoViricides President Dr. Diwan Invited to Present a Seminar at the Center for Biological Physics and the California NanoSystems Institute at UCLA

WEST HAVEN, Conn.–(BUSINESS WIRE)– NanoViricides, Inc. (OTC BB: NNVC) (the “Company”) announced today that its President, Dr. Anil Diwan, has been invited to present a seminar at the University of California, Los Angeles. This seminar will be hosted by the Center for Biological Physics, jointly with the California NanoSystems Institute. The seminar is scheduled for Friday, 22nd of March.

“I am honored to have this opportunity to discuss our work with eminent biophysicists that are researching the interactions and structural stability of viruses,” said Anil Diwan, PhD, President of the Company, adding, “Biophysics is the key to understanding our approach to develop nanoviricides®, our novel biomimetic agents designed to destroy viruses.”

Dr. Diwan’s talk is entitled “Designing a Nanoviricide ® – Biophysics is the Key”.

A “nanoviricide ®”, is a biomimetic decoy designed to fool a virus particle into binding to it and thereby capturing the virus particle and rendering it harmless. It is constructed by chemically attaching virus-binding ligands to a polymeric micelle. Biophysics is of prime importance in designing these structures. The biomimetic ligands tend to have poor energies of interaction with the virus particle per ligand, yet a large number of ligands enable a successful interaction with the virus particle. Additionally, the nanoviricide competes with cells for binding to the virus particle, and must provide a substantially more efficient interaction than the cell-virus interaction, in order to achieve a therapeutic effect. The nanoviricide also must be able to exercise its effect in the biological matrix, be it in the bloodstream, plasma, mucosa, or other extracellular spaces. Further, it should have minimal undesirable interaction with the matrix and host cells so that sufficient material is available for clearing out a fulminant viral infection from a patient’s body. In addition, the nanoviricide needs to be able to distribute itself within the body, across various barriers, so that it can reach the spaces where the virus particles are present. NanoViricides, Inc. has demonstrated that highly effective antiviral treatments can be created against a large number of viruses, despite these design challenges. The challenges and opportunities for understanding the behavior of virus-nanoviricide interactions, and the results from studies of nanoviricides development against various viruses such as influenza, HIV, Herpesvirus, adenoviruses, Dengue viruses, will be discussed.

The first ever orally active nanomedicine has been developed by NanoViricides, Inc. This oral anti-influenza drug candidate has shown very high bioavailability. NanoViricides also has an injectable anti-influenza drug in development towards clinical studies for serious cases of influenza. A pre-IND meeting with the FDA has helped the Company …read more
Source: FULL ARTICLE at DailyFinance

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Pernix Therapeutics Reports Fourth Quarter and Full Year 2012 Financial Results

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By Business Wirevia The Motley Fool

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Pernix Therapeutics Reports Fourth Quarter and Full Year 2012 Financial Results


Completed Acquisition of Cypress Pharmaceuticals and Hawthorn Pharmaceuticals


Completed the Acquisition of Somaxon Pharmaceuticals in March 2013


Announced Plans to Launch Dr. Cocoa, an OTC Chocolate Flavored Cough & Cold Product Line

THE WOODLANDS, Texas–(BUSINESS WIRE)– Pernix Therapeutics Holdings, Inc. (“Pernix” or the “Company”) (NAS: PTX) , a specialty pharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2012.

Financial Results

For the fourth quarter of 2012, net revenues were $18.2 million, compared to $21.4 million for the fourth quarter of 2011. Total net product revenues consisted of 53% revenue contribution from branded products and 47% revenue contribution from generic products in the fourth quarter of 2012.

The net loss for the fourth quarter of 2012 was approximately $(1.4) million, or $(0.05) per basic and diluted share, compared to net income of $3.9 million, or $0.15 per basic and diluted share, for the fourth quarter of 2011.

“This past year was a time for investing and building in Pernix’s continued success,” said Cooper Collins, President and Chief Executive Officer of Pernix. “Looking forward in 2013, we are focused on several key objectives that are expected to drive the Company’s future growth, which include the following: integrating Cypress and Hawthorn, re-launching Silenor by our newly-combined Pernix and Hawthorn sales forces, initiating our Phase III clinical trials for our pediatric product, launching Dr. Cocoa, an OTC chocolate flavored cough and cold product for the 2013-2014 cough and cold season, beginning the development of Silenor as an OTC product, and working toward the IND filings of two products in Hawthorn’s pipeline. We are also capitalizing on the synergies of our acquisitions, and improving efficiencies across all of our operations.”

…read more
Source: FULL ARTICLE at DailyFinance

Linux

Date increment logic

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By pmreddy

Hi all,

I need to increment date at run time.

Example:

I need to write a shell script with two parameters.
1. country code like (US,UK, IND…..)
2. Date range from_date to to_date (20070101 to 20070331)

I need to run shell script like this

country_info.sh US 20070101 20070331

first time the shell script takes US and 20070101
after completion of above second time it takes US and 20070102
.
.
.
.
lastly it takes US and 20070331
then exits

I need to skip saturdays and run the script all other days from the above date range.

Please help me

Thanks

Source: FULL ARTICLE at The UNIX and Linux Forums