Investigational New Drug

Type: Keyphrase

Name: Investigational New Drug

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Fecal transplants to treat C. diff now need FDA approval

The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.The FDA has not issued a formal rule, but researchers and healthcare ... [Published McKnight's Long Term Care News - May 17 2013]

Entities: FDA Food & Drug Administration, Clostridium Difficile, Investigational New Drug

First reported May 15 2013 - Updated May 16 2013 - 1 reports

DLF Ltd

Markets rally; top twelve stocks in action

NEW DELHI: The S&P BSE Sensex surged over 300 points in mid-morning trade on Wednesday to regain its crucial level of 20,000, led by rally in rate sensitive stocks. While Nifty rallied 100 points, or 1.7 per cent to post its best percentage gain since ... [Published Economic Times - May 15 2013]

Entities: Investigational New Drug, DLF Ltd, Real Estate

First reported May 15 2013 - Updated May 15 2013 - 1 reports

FDA halts U.S. poop transplants pending further review

Topics: fda ♦ food and drug administrationThe Food and Drug Administration has ordered clinicians to stop transplanting healthy fecal matter from one patient to another until the agency has had a chance to review and test the procedure.According to the ... [Published Raw Story - May 15 2013]

Entities: FDA Food & Drug Administration, Clostridium Difficile, Infectious Diseases, Microbiota

First reported May 14 2013 - Updated May 15 2013 - 4 reports

Piramal Enterprises receives nod from USFDA for anti-diabetes molecule

Piramal Enterprises has received approval from US Food and Drug Administration (USFDA) for its investigational new drug (IND), P11187, which aims to target diabetes. This will enable the company to initiate a Phase I clinical trial of new chemical entity ... [Published Indian-Commodity - May 15 2013]

Entities: Piramal Enterprises Ltd, Molecule, Nicholas Piramal, Piramal Group, Piramal Healthcare Ltd

First reported May 13 2013 - Updated May 13 2013 - 1 reports

Inventiva, NovAliX establish strategic alliance

STRASBOURG, FranceA strategic alliance has been announced between Inventiva and NovAliX, under which the partners will focus on discovering clinical candidates that target nuclear receptors. The alliance allows Inventiva and NovAliX to provide a set of ... [Published Drug Discovery News - May 13 2013]

Entities: Receptor, Nuclear, Investigational New Drug, collaboration

First reported May 09 2013 - Updated May 09 2013 - 1 reports

Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug ApplicationQuestions and Answers; Availability

5/9/13 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application--Questions and Answers; AvailabilityNotice of availability.CFR Part: "21 CFR Part 312"Citation: "78 FR 27116"Document Number: "Docket ... [Published Pharmacy Choice - May 09 2013]

Entities: investigational, FDA Food & Drug Administration, Drugs, Investigational New Drug

First reported Apr 25 2013 - Updated Apr 25 2013 - 1 reports

Tel Aviv Stock Exchange

FDA demands more data from Insuline

The FDA said that the company did not provide enough information about the safety and efficacy of its InsuPatch insulin pump.25 April 13 15:07, Globes' correspondentThe share price of InsuLine Medical Ltd. (TASE: INSL) fell 14.3% by mid-afternoon today, ... [Published Globes - Apr 25 2013]

Entities: Insulin, Investigational New Drug, de Novo, Tel Aviv Stock Exchange, Pharmacokinetics

First reported Apr 22 2013 - Updated Apr 23 2013 - 2 reports

BIND Therapeutics, AstraZeneca ink cancer nanomedicine agreement

BIND Therapeutics, a clinical-stage biopharmaceutical company, and AstraZeneca have entered into a strategic collaboration to develop and commercialize an Accurin, a targeted and programmable cancer nanomedicine from BIND's medicinal nanoengineering platform, ... [Published Center Watch - Apr 23 2013]

Entities: Bind Therapeutics Inc, AstraZeneca PLC, Cancer, Scott Minick, Investigational New Drug

First reported Apr 17 2013 - Updated Apr 17 2013 - 1 reports

ARMGO Pharma Receives $1 Million Award from MDA to Support Advancement of Rycal Compound ARM210 as a PR Newswire

/PRNewswire/ --$ ARMGO Pharma and the Muscular Dystrophy Association (MDA) today announced that $1 Million has been awarded for preclinical work in support of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) ... [Published Yahoo! Finance - Apr 17 2013]

Entities: ARMGO Pharma Inc, Investigational New Drug, Drugs, Muscular Dystrophy, treatments

First reported Apr 12 2013 - Updated Apr 13 2013 - 1 reports

Portola Pharmaceuticals seeks $115 million IPO

will seek $115 million in one of biotech's largest IPOs this year.The South San Francisco drug developer, long seen as a prime candidate for an initial public offering, said in a Securities and Exchange Commission filing late Friday that it would use ... [Published San Francisco Business Times - Apr 12 2013]

Entities: Portola Pharmaceuticals Inc, Betrixaban, IPOs

First reported Feb 07 2013 - Updated Feb 07 2013 - 1 reports

Regen BioPharma Files Investigational New Drug (IND) Application With FDA On HemaXellerate Iâ¢ Stem Cell Drug For Aplastic Anemia

Sorry, there is a problem with our siteThe page you have requested cannot be displayedThis occurrence has been logged for quality assurance purposes. ... [Published Bioresearch Online - Feb 07 2013]

Entities: Regen BioPharma, aplastic anemia, Investigational New Drug, Stem Cell, Drugs

First reported Jan 30 2013 - Updated Jan 30 2013 - 1 reports

ImmunoCellular Therapeuticsâ Investigational New Drug (IND) Application For ICT-140 Allowed By The FDA

Sorry, there is a problem with our siteThe page you have requested cannot be displayedThis occurrence has been logged for quality assurance purposes. ... [Published Bioresearch Online - Jan 30 2013]

Entities: Investigational New Drug, FDA Food & Drug Administration

Quotes

...Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so" and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for...

Alnylam Presents Key Pre-Clinical Proof-of-Concept Data for ALN-AS1, an RNAi Therapeutic Targetin ... [Published Business Wire - May 17 2013]

Mine is more of an independent practice. I can cover whatever I want. The people in asset management may say, "Hey, we're looking at investing in this. What do you thinkthink about it?" Then I'll do a little work for them, but it's separate from what I'm publishing. The buyside and sellside are separate companies

Two Biotech Ideas You May Have Missed: William Gregozeski [Published InvestorIdeas.com - May 16 2013]

..."We found that cancer cells need a continuous exposure at low concentrations for the drug to be of maximum effectiveness," Toretsky says. "And this strategy works extremely well in these animal models. The drug appears to be very successful."

Preclinical tests shows agent stops 'slippery' proteins from binding, causing Ewing sarcoma [Published EurekAlert! - May 15 2013]

...clinical study at Dartmouth Medical Center for PAZ320 in Type 2 diabetes," said David Platt, Ph D , Chief Executive Officer of Boston Therapeutics. "The addition of Dr. Sheehan to our team has given us a tremendous boost in this direction. Going forward, as I have indicated previously, we intend to focus our pipeline on commercializing PAZ320 and IPOXYN, which will enable the Company to advance its status as a premier developer of complex carbohydrate-based new chemical entities. Achieving these goals will also enable us to address the rapidly expanding global diabetes market." Revenue for the three month period ended March 31, 2013 was $23,336 compared with $18,854 for the same period in the prior year, an increase of $4,482...

Boston Therapeutics Reports First Quarter 2013 Results [Published Stockhouse Canada - May 15 2013]

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Boston Therapeutics Reports First Quarter 2013 ... [Published Stockhouse Canada - May 15 2013]
FDA halts U.S. poop transplants pending further... [Published Raw Story - May 15 2013]
Cleveland BioLabs and Incuron receives patent a... [Published Individual.com - May 15 2013]
Tokai Pharmaceuticals Inks $35.5m Series E [Published PE Hub News - May 15 2013]
Tokai Pharmaceuticals Announces $35.5 Million S... [Published BioPortfolio - May 15 2013]
Piramal Enterprises Limited receives IND approv... [Published Noodls - May 15 2013]
Markets rally; top twelve stocks in action [Published Economic Times - May 15 2013]
Piramal Enterprises receives nod from USFDA for... [Published Indian-Commodity - May 15 2013]
OIL, Hero MotoCorp, Sterlite Industries and SAI... [Published Indian-Commodity - May 15 2013]
Induced pluripotent stem cells in high-throughp... [Published Drug Discovery World - May 14 2013]
Piramal Enterprises receives IND approval from ... [Published Express Pharma - May 14 2013]
Piramal gets USDFA nod for anti-diabetic molecule [Published Economic Times - May 14 2013]
Cleveland BioLabs and Incuron Announce US and E... [Published Yahoo! Finance - May 14 2013]
Piramal Enterprises gets US nod for anti-diabet... [Published Business Standard India - May 14 2013]
Piramal receives IND approval from US FDA for G... [Published India Infoline - May 14 2013]
Piramal receives US FDA approval for anti-diabe... [Published PharmaBiz - May 14 2013]
Inventiva, NovAliX establish strategic alliance [Published Drug Discovery News - May 13 2013]
ImmunoGen, Inc. Reports Third Quarter Fiscal Ye... [Published Pharmacy Choice - May 13 2013]
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