Stellar Biotechnologies and Araclon Biotech Sign Exclusive KLH Supply Agreement for Clinical Trials in Alzheimer's Active Immunotherapies

PORT HUENEME, CA--(Marketwired - Nov 11, 2014) - Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) and Araclon Biotech SL ("Araclon") today announced that the companies have executed a definitive exclusive supply agreement to meet Araclon's Phase (II and III) clinical trial requirements for Keyhole Limpet Hemocyanin (KLH) used in Araclon's active immunotherapies against Alzheimer's disease.

Stellar is a leader in sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in immunotherapy development. KLH manufacturing is limited by the fact that this important molecule can only be produced from a scarce marine source and Stellar believes it is the only company that has the technology to manage the controlled production of this resource.

Published: 11 November 2014

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Threshold Pharmaceuticals Receives FDA Fast Track Designation for TH-302 for the Treatment of Previously Untreated Patients With Metastatic or Locally Advanced Unresectable Soft Tissue Sarcoma

SOUTH SAN FRANCISCO, CA--(Nov 11, 2014) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS).

Published: 11 November 2014

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Nasdaq FDA HC Decision Up on News

AcelRx Pharmaceuticals Reports Third Quarter 2014 Financial Results

REDWOOD CITY, Calif., Nov. 10, 2014 -- AcelRx Pharmaceuticals, Inc. (ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and nine months ended September 30, 2014.

"In the third quarter, we held a meeting with the FDA to discuss the Zalviso CRL received in July. During the meeting we discussed the resubmission of the Zalviso NDA and the steps necessary for the resubmission," stated Richard King, president and CEO of AcelRx. "In advance of resubmitting our Zalviso NDA, we have agreed with the FDA to submit protocols for the bench testing and a Human Factors Study for their review and comment. We currently continue the preparation necessary to initiate bench testing and a Human Factors study to enable response to the CRL."

Published: 11 November 2014

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Nasdaq

Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

- Achillion Achieves 100% SVR12 in Eight-Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy Study") Including Nine of 12 Patients With Viral Loads Higher Than 6 Million IU/ml at Baseline --

- Reports Additional Preclinical Results for ACH-3422, Uridine-Analog Nucleotide NS5B Polymerase Inhibitor --

NEW HAVEN, Conn., Nov. 8, 2014 -- Achillion Pharmaceuticals, Inc. (ACHN) today announced the presentation of results from the ongoing Phase 2 study of ACH-3102 in a late breaker poster and data in three preclinical posters on ACH-3422. The poster presentations are being made at the 65^th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting 2014, which takes place through November 11, 2014 in Boston, MA.

Published: 10 November 2014

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Nasdaq Up on News Project Update

FDA Advisory Committee Recommends Rockwell Medical's Triferic for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients

Triferic Phase 3 Efficacy and Safety Results Support Positive Benefit/Risk

WIXOM, Mich., Nov. 6, 2014 -- Rockwell Medical, Inc. (RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food & Drug Administration (FDA) recommended that the Phase 3 Triferic efficacy and safety results support a positive benefit/risk to treat iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD). The ODAC voted in favor of Triferic by a vote of 8 to 3.

Published: 07 November 2014

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FDA HC Decision

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Stellar Biotechnologies Inc ( KLH )

Stellar Biotechnologies and Araclon Biotech Sign Exclusive KLH Supply Agreement for Clinical Trials in Alzheimer's Active Immunotherapies

Threshold Pharmaceuticals ( THLD )

Threshold Pharmaceuticals Receives FDA Fast Track Designation for TH-302 for the Treatment of Previously Untreated Patients With Metastatic or Locally Advanced Unresectable Soft Tissue Sarcoma

AcelRx Pharmaceuticals Inc ( ACRX )

AcelRx Pharmaceuticals Reports Third Quarter 2014 Financial Results

Achillion Pharmaceuticals Inc ( ACHN )

Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

Rockwell Medical Inc ( RMTI )

FDA Advisory Committee Recommends Rockwell Medical's Triferic for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients