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Protocol in Biological Technology

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

QUEBEC CITY, Aug. 3 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS , TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ), its partner and licensee for perifosi...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) today announced finalization of the protocol for the Company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance o...

BioNeutral's Ygiene(TM) Hospital Grade Achieves a 100% Total Kill (Pass) Against the Life Threatening Clostridium Difficile (C.diff) Spores in Independent EPA Required Protocol Testing.

NEWARK, N.J., July 21 /PRNewswire-FirstCall/ -- BioNeutral Group, Inc. ("BioNeutral") (OTC Bulletin Board: BONU), a specialty chemical technology based Life Science Company announced today that at ATS Labs using the required EPA protocol testing, BioNeutral's Ygiene(TM) Hospital Grade Antimic...

OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

BOTHELL, WA, and VANCOUVER, June 24 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI ) announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) via the special protocol assessment process (SPA) on an amendment to the design ...

Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment

LA JOLLA, Calif., July 23 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FD...

OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011

VANCOUVER, July 14 /PRNewswire/ - OncoGenex Technologies Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate ca...

Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial

Pivotal Trial in Medullary Thyroid Cancer Planned to Initiate This Summer SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL ) announced today that the company and the U.S. Food and Drug Administration (FDA) have reached agreement on the phase 3 registr...

FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE

-Amended Agreement Accelerates Expected Timing of Final Analysis by One Year While Maintaining Comparable Powering of Interim and Final Results- -Dendreon to Hold Conference Call on Thursday, March 13, 2008 at 11:00 AM ET- SEATTLE, March 12 /PRNewswire-First...

Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer

Trial will also Support a Marketing Authorization Application in the European Union HOUSTON, Jan. 17 /PRNewswire/ -- Agennix Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial e...

ZymoGenetics and Merck Serono Receive FDA Special Protocol Assessment for Atacicept Pivotal Study in Lupus Nephritis

- Patient enrollment to begin in fourth quarter - SEATTLE, Oct. 4 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN) today announced that, together with its collaborator Merck Serono, it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Pro...

BioLife Solutions' CryoStor(TM) Adopted by Tissue Regeneration Therapeutics for Preservation Protocol for New, Non-Embryonic Source of Stem Cells

Umbilical Cord Tissue Provides Building-Block Cells for Muscle, Bone, Connective Tissues BOTHELL, Wash., Sept. 17 /PRNewswire-FirstCall/ -- BioLife Solutions Inc. (OTC Bulletin Board: BLFS), a leading developer and marketer of proprietary hypothermic storage and cryo...

Cancer Clinics of Excellence (CCE) Releases 62nd Evidence-Based Treatment Protocol

SCOTTSDALE, Ariz., Feb. 6 /PRNewswire/ -- Cancer Clinics of Excellence, LLC, the nation's only physician-driven network of community oncologists, announced the completion of its 62nd comprehensive Evidence-Based Treatment Protocol covering 11 of the leading oncology disease states at the 4th Annua...

Haemonetics Announces Launch of Faster Plasma Collection Protocol

BRAINTREE, Ma., June 16 /PRNewswire-FirstCall/ -- Haemonetics Corporation announced today at the annual meeting of the Plasma Protein Therapeutics Association the launch of a plasma collection software for its PCS(R)2 plasma collection system that reduces plasma donation time by 20%. Stephen...

High Yield Protein Production from Pichia pastoris Yeast: A Protocol for Benchtop Fermentation

By Julia Cino, PhD Introduction Over the last several decades, geneticists have learned how to manipulate DNA to identify, excise, move and place genes into a variety of organisms that are quite different genetically from the source organism. A ma...

GenomiPhi: protocol for BAC amplification and fabrication of slides for array CGH

Prasad D.K. Dhulipala 1 , Rao S. Takkellapati 1 , Kate Lavrenov 1 , Scott Hamilton 1 , and Jessica Pole 2 1 GE Healthcare, Piscataway, NJ, USA 2 Hutchison/MRC Research Centre, University of Cambridge, Cambridge, UK ...

Genomic DNA Isolation Protocol for 40 l Avian Whole Blood

AquaPure Genomic DNA Isolation Kit Catalog #732-6340 Expected yield range: 100300 g DNA Method Cell Lysis 1. Use fresh blood within 10 sec of venipuncture to avoid clotting. Alternatively, collect w...

Total RNA Isolation Protocol 1,2,3

Sample Preparation: To extract RNA from washed and pelleted cultured cells, add 200 l 4 M Guanidinium Isothiocyanate Solution (4M Guanidinium Isothiocyanate, 25 mM Sodium...

CELLocate protocol blocks for 55 m microgrid

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CELLocate protocol blocks for 175 m microgrid

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RNAqueous-96 RNA Isolation Kit Automation Protocol

This protocol was developed for the MultiPROBE II HT Liquid Handling System with a Gripper Integration Platform. Time required: 1 hr 20 min. For more information on the protocol, see the

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

...f randomization (46% reduction in mortality, p=0.04). Based on data from the prior Phase 3 study of orBec(R), the upcoming confirmatory Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients. The prim...

Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

...Life Sciences is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed t... closely with the Agency to design and establish a protocol under a Special protocol Assessment. The company anticipates that initiatio...

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

... "With our enhanced cash position, reduced cost structure and Phase II protocol allowance from the FDA, we are well positioned to continue advancing the de... Finalization of ANA598 Phase II Protocol. Anadys has finalized its protocol and received FDA clearance for the Phase II study of ANA598 in combination ...

United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients

...nation gene and stem cell therapy for cardiovascular disease." The U.S. trial is expected to begin this year. After completing the REGEN safety protocol with one-month follow-up, the company hopes to transition this second-generation product into its FDA-authorized Phase II/III MARVEL study. MyoCell SD...

SAPHRIS(R) (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Schizophrenia

...a later date. These results follow those of a previously reported clinical trial in this patient population using the same study design and protocol in which both asenapine and olanzapine reduced negative symptoms after one year of treatment, but the difference between the two was not statistically...
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