Therapeutics News and Research

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Halozyme announces voluntary HYLENEX product recall

Halozyme Therapeutics, Inc. today announced that Halozyme and Baxter have confirmed the presence of small flake-like glass particles in a limited number of vials of HYLENEX® (hyaluronidase human injection) product at the Baxter manufacturing facility. Earlier today, Halozyme notified the U.S. Food and Drug Administration that it is voluntarily recalling affected lots of 150U HYLENEX product from distribution.

17 May 2010

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Emergent BioSolutions Inc. announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

17 May 2010

Celldex Therapeutics commences screening in CDX-1307 Phase 2 study for bladder cancer

Celldex Therapeutics, Inc. today announced that the first patient has been screened in a randomized Phase 2 study of the Company's novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta.

17 May 2010

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Halozyme Therapeutics, Inc. today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter's failure to provide HYLENEX (hyaluronidase human injection) in accordance with the terms of the parties' existing development and supply contracts.

17 May 2010

Roche to commence clinical study of TB-403 in patients with colorectal and ovarian cancer

BioInvent International AB and ThromboGenics NV announce today that their partner Roche will begin an imaging study with the novel anti-cancer antibody TB-403 (RG7334) in patients with metastatic, treatment-refractory, colorectal and ovarian cancer.

17 May 2010

Cell Therapeutics announces exchange agreements for 4% Convertible Senior Subordinated Notes due 2010

Cell Therapeutics, Inc. today announced that it has entered into exchange agreements with certain holders of some of the Company's outstanding 4% Convertible Senior Subordinated Notes due 2010.

17 May 2010

3SBio's first-quarter 2010 total net revenues up 40.5%

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced its unaudited financial results for the first quarter ended March 31, 2010.

17 May 2010

Cell Therapeutics' Special Meeting of Shareholders adjourned to June 4, 2010

Cell Therapeutics, Inc. today announced that the Company has adjourned today's Special Meeting of Shareholders to 10:00 am Pacific Daylight Time, Friday, June 4, 2010.

15 May 2010

NASDAQ Biotechnology Index semi-annual re-ranking to become effective May 24, 2010

The NASDAQ OMX Group, Inc. announced today the results of the semi-annual re-ranking of the NASDAQ Biotechnology Index®, which will become effective prior to market open on Monday, May 24, 2010.

15 May 2010

Protox announces positive top-line results from the TRIUMPH study in first quarter 2010

Protox Therapeutics Inc. a leader in the development of receptor targeted fusion proteins, today released financial results for the first quarter 2010, ended March 31, 2010. "The first quarter of 2010 marked significant achievements for the company, namely the announcement of positive top-line results from the TRIUMPH study and the subsequent completion of a five million dollar financing," said Dr. Fahar Merchant, President and CEO of Protox.

15 May 2010

U.S. Patent and Trademark Office grants patent to Historx's AQUA technology

HistoRx , Inc., announced today that the U.S. Patent and Trademark Office has granted a patent protecting the company's methods for determining a cancer patient's prognosis based on sub-cellular localization of biomarkers.

15 May 2010

New research facility at Riley Hospital for Children to improve clinical research trials for children

A new research facility at Riley Hospital for Children will dramatically improve the process of turning the results of laboratory research into new treatments for sick children, federal and local officials said Friday.

15 May 2010

Nile Therapeutics reports net loss of $1.9M for first-quarter 2010

Nile Therapeutics, Inc., a company focused on the development of novel therapeutics for heart failure patients, today announced its first quarter financial results for 2010.

14 May 2010

NanoViricides signs research and development agreement with Dr. Ken S. Rosenthal's laboratory

NanoViricides, Inc., reports that it has signed a research and development agreement with Dr. Ken S. Rosenthal's laboratory at Northeastern Ohio Universities Colleges of Medicine and Pharmacy.

14 May 2010

Opexa Therapeutics reports lower net loss of $1.4M for first-quarter 2010

Opexa Therapeutics, Inc., a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2010 and provided an update on its corporate developments.

14 May 2010

Guided Therapeutics first-quarter service revenue increases to $821,000

Guided Therapeutics, Inc. today announced its operating results for the first quarter of 2010.

14 May 2010

Chimerix commences first-in-human study of CMX157 for HIV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the commencement of a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). CMX157 has the potential to increase efficacy and decrease toxicity as compared to tenofovir, and may enable the creation of new 'one pill, once-a-day', fixed-dose combination regimens for the treatment of HIV infection.

14 May 2010

Rexahn Pharmaceuticals announces Phase IIb clinical trial of Zoraxel for ED

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it will initiate a Phase IIb clinical trial for ZoraxelTM in the treatment of erectile dysfunction (ED).

13 May 2010

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

ARYx Therapeutics, Inc. today reported results of operations and provided an update on its business activities for the first quarter ended March 31, 2010.

13 May 2010

Palatin Technologies reports net loss of $2.0M for third-quarter 2010

Palatin Technologies, Inc., a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics, today announced results for its third quarter ended March 31, 2010.

13 May 2010

Therapeutics News and Research

Halozyme announces voluntary HYLENEX product recall

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Celldex Therapeutics commences screening in CDX-1307 Phase 2 study for bladder cancer

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Roche to commence clinical study of TB-403 in patients with colorectal and ovarian cancer

Cell Therapeutics announces exchange agreements for 4% Convertible Senior Subordinated Notes due 2010

3SBio's first-quarter 2010 total net revenues up 40.5%

Cell Therapeutics' Special Meeting of Shareholders adjourned to June 4, 2010

NASDAQ Biotechnology Index semi-annual re-ranking to become effective May 24, 2010

Protox announces positive top-line results from the TRIUMPH study in first quarter 2010

U.S. Patent and Trademark Office grants patent to Historx's AQUA technology

New research facility at Riley Hospital for Children to improve clinical research trials for children

Nile Therapeutics reports net loss of $1.9M for first-quarter 2010

NanoViricides signs research and development agreement with Dr. Ken S. Rosenthal's laboratory

Opexa Therapeutics reports lower net loss of $1.4M for first-quarter 2010

Guided Therapeutics first-quarter service revenue increases to $821,000

Chimerix commences first-in-human study of CMX157 for HIV

Rexahn Pharmaceuticals announces Phase IIb clinical trial of Zoraxel for ED

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

Palatin Technologies reports net loss of $2.0M for third-quarter 2010

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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