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Ind in Medical News

Cytopia Lodges IND for JAK2 Inhibitor CYT387

MELBOURNE, Australia, June 22 /PRNewswire/ -- Cytopia Ltd (ASX: CYT) announced today that it has filed an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) for its novel, potent orally active JAK2 inhibitor CYT387. Following FDA review, the company int...

FDA Clears Cellectar's IND Application for Lead Drug Candidate

(131)I-CLR1404 to Enter Clinical Trials MADISON, Wis., March 3 /PRNewswire/ -- Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, today announced that the U.S. Food and Drug Administration (FDA) has c...

Barnett Releases IND Submissions: A Primer

Barnett International, a division of Cambridge Healthtech Institute, has announced the release of IND Submissions: A Primer, an in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments. IND Submissions: A Primer is the only comprehensive IND manu...

FDA embraces a new review process and approves SNM's multi-center IND for FLT

Reston, Va.SNM today announced FDA approval of an SNM-sponsored centralized multi-center investigational new drug (IND) application for 18F-labeled 3'-deoxy-3'-fluorothymidine (FLT). The approval of multi-center Chemistry Manufacturing and Controls (CMC) in the FLT IND represents the successful...

Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia

CAMBRIDGE, Mass., Dec. 17 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR ) announced today that it has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a pilot phase 2 clinical trial of the company's oxygen therapeutic Hem...

TheraQuest's IND for Abuse Deterrent Strong Opioid (TQ-1015) Accepted by FDA

BLUE BELL, Pa., Nov. 13 /PRNewswire/ -- TheraQuest Biosciences, Inc. a development stage pain management company today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug ("IND") application for TQ-1015, its abuse deterrent extended release stro...

DURECT Announces the IND Submission for a Third Abuse-Resistant Opioid Pain Medication Based on Its ORADUR(TM) Technology

CUPERTINO, Calif., Aug. 27 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) today reported that Pain Therapeutics (Nasdaq: PTIE ), its licensee, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioi...

Quark Pharmaceuticals Receives FDA Approval of IND for Kidney Transplant siRNA Drug DGFi

Quark's second siRNA drug delivered systemically FREMONT, Calif., June 25 /PRNewswire/ -- Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate,...

Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)

SAN FRANCISCO, June 3 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Investigational New Drug (IND) application for its lead compound, MitoQ(R). With the IND acceptance, the Company will in...

Algeta Receives IND Approval for Alpharadin(TM) to Commence Clinical Development in the USA

OSLO, February 21 /PRNewswire-FirstCall/ -- Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead prod...

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Ind in Medical Technology

FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway

PARSIPPANY, N.J., May 11 /PRNewswire-FirstCall/ -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") accepted the Company's Investigational New Drug ("IND") application for the us...

U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting

CAMBRIDGE, Mass., March 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR ) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) application to conduct a clinical trial of ...

U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'Op RESUS' Clinical Trial in Trauma Patients in the Battlefield Setting

CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR ) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) application to conduct a clinical trial of th...

deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimer's and Other Cognitive Disorders

REYKJAVIK, Iceland, Oct. 3 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN ) today announced the filing of an investigational new drug (IND) application for DG071, the company's novel small-molecule modulator of phosphodiesterase 4 (PDE4), with the US Food and Drug Administration (FDA...

Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer

SEATTLE, July 23 /PRNewswire/ -- Sound Pharmaceuticals (SPI) has filed an Investigational New Drug Application with the FDA for the clinical testing of a proprietary formulation of ebselen for the prevention of chemotherapy induced hearing loss or ototoxicity. The oral capsule containing ebsel...

Genaera Announces Diabetes IND In Effect for Trodusquemine (MSI-1436)

- Second filing provides opportunity for additional indications and increased potential market - PLYMOUTH MEETING, Pa., Jan. 23 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR ) today announced that the investigational new drug (IND) application submitted to...

Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B

LAGUNA NIGUEL, Calif., Nov. 13 /PRNewswire/ -- Inspiration Biopharmaceuticals announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with IB1001, an intravenous recombinant Factor IX (rFIX) produ...

Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs

SAN DIEGO, Aug. 7 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today reported financial results for the quarter ended June 30, 2007. Revenues for the second quarter of 2007 were $3.1 million, compared with revenues of $7.3 million for the second quarter of 2006. The net loss for...

Clinical Update - Debio 9902 SR (ZT-1) for Alzheimer Patients Debiopharm Starts Tablet Formulations Bridging Study under IND

LAUSANNE, Switzerland, October 21 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that the first healthy elderly subjects have been randomised in a clinical bi...

FDA approves IND on Lead Product M6G

CAMBRIDGE, England, 26th April 2007 - CeNeS Pharmaceuticals plc (LSE: CEN), the Cambridge based biopharmaceutical company, today announces that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the clinical development of morphine-...

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Ind in Biological Technology

Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma

EVRY, France, May 5 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, announces today that the Company's Investigational New Drug Application (IND) to conduct a Phase III clinical trial of Catioprost(R) (Nova21027), for the treatment of glaucoma has been granted by t...

FDA Accepts IND for Arno Therapeutics' Pan-DAC / Akt Inhibitor, AR-42

PARSIPPANY, N.J., March 17 /PRNewswire-FirstCall/ -- Arno Therapeutics, Inc. (OTC Bulletin Board: ARNI), a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") accepted the Company's Investigational New Drug (...

Tigris Pharmaceuticals Files IND Application for GGTI-2418

BONITA SPRINGS, Fla., Feb. 6 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., a privately held drug development company, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for GGTI-2418, a novel anticancer compound. GGTI-2...

SemBioSys submits IND for safflower-produced insulin to U.S. FDA

- Submission demonstrates progress of plant-derived insulin program scheduled to enter the clinic later this year - TSX symbol: SBS CALGARY, July 29 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for meta...

FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics' Unique Proprietary Chemistry

Quark Pharmaceuticals to develop drug candidate for prevention and treatment of delayed graft function in kidney transplantation LONDON, June 25 /PRNewswire/ -- Silence Therapeutics plc (London AIM: SLN) today announces that the U.S. Food and Drug Administration (FDA) has approved a Qua...

PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008

ANNAPOLIS, Md., March 6 /PRNewswire-FirstCall/ -- PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that it has completed the initial pharmacokinetic (PK) testing of ...

EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076

ROCKVILLE, Md., Jan. 3 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigati...

Roche Files IND for Second Genmab Antibody

Summary: Genmab's Partner Roche has Filed an IND With the US FDA for a Genmab Antibody COPENHAGEN, August 10 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today that its partner Roche has filed an Investigational New Drug application (IND) with the US Fo...

Sequoia Pharmaceuticals Files Second IND for 2007

Novel Drug Enhances Pharmacokinetic Properties of Co- Administered Therapeutics GAITHERSBURG, Md., Dec. 7 /PRNewswire/ -- Sequoia Pharmaceuticals, Inc. announced today that it has submitted an investigational New Drug Application (IND) with the United States Foo...

Nitec's IND Application for Clinical Development With Lodotra Accepted by the FDA

BASEL, Switzerland, September 24 /PRNewswire/ -- Nitec Pharma AG today announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application submitted by Nitec for the initiation of clinical development for Lodotra. Following the positive results...

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