Biopharmaceutical News and Research

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New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

Santarus, Inc., a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema were presented at the 7th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.

23 May 2011

Sosei to introduce NorLevo oral emergency contraceptive in Japan

Sosei Group Corporation, the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, will launch its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, tomorrow 24 May, through the distribution network of its commercialization partner, ASKA Pharmaceutical Co., Ltd.

23 May 2011

CSL welcomes historic pandemic agreement

CSL Biotherapies welcomed news overnight of a decision by the World Health Assembly to adopt the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The Framework is the culmination of several years work by a dedicated working group of the World Health Organisation (WHO) and paves the way for greater global collaboration between public and private stakeholders in preparing the world for possible future influenza pandemics.

19 May 2011

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer.

19 May 2011

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has initiated a Phase 2 clinical trial of arhalofenate (MBX-102), its product candidate for the management of hyperuricemia in patients with gout.

19 May 2011

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine's core technology.

19 May 2011

Mpex, Synteract partner for cystic fibrosis fundraising event

Synteract, Inc., a full-service, global contract research organization, and Mpex Pharmaceuticals, a biopharmaceutical company developing new therapies to combat the growing issue of antibiotic resistance, have partnered for the second annual Great Strides fundraiser to benefit cystic fibrosis.

19 May 2011

CITN selects Cytheris' CYT107 for initial clinical trials at network institutions

Cytheris SA and the Cancer Immunotherapy Trials Network, a new initiative in immunotherapy funded by the National Cancer Institute with its Central Operations and Statistical Center headquartered at Fred Hutchinson Cancer Research Center, Seattle, Washington, today announced the selection of recombinant human interleukin-7, the investigational multifunctional cytokine under development by Cytheris, as one of the first immunotherapeutic agents proposed for initial clinical trials at network institutions.

18 May 2011

HII, CDISC launch new project to harmonize health research guidelines

A Project to harmonize health research guidelines was launched today by the Health Improvement Institute in partnership with the Clinical Data Interchange Standards Consortium.

17 May 2011

ProBioGen, Life Technologies' new cell line development kits now available for biologic drug production

Life Technologies Corporation and ProBioGen AG today announced the availability of Gibco Freedom Cell Line Development Kits, a new line of royalty-free products that integrate cells, reagents, culture media and protocols to bring simplicity and flexibility, eliminating up to two months in the earliest stages of new biological drug development.

17 May 2011

CytRx sells global rights of molecular chaperone assets to Orphazyme

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that it has sold the worldwide rights to its molecular chaperone assets to privately-held, Copenhagen, Denmark-based Orphazyme ApS.

17 May 2011

PGT, Quintiles collaborate to bring genomic testing into mainstream drug development

Quintiles, the world's leading biopharmaceutical services company, and Population Genetics Technologies Ltd., creator of innovative solutions to reduce the costs and complexity of large-scale genomic testing and enable correlations with clinical outcomes, today announced a commercial collaboration to bring genomic testing into mainstream drug development in order to produce safer, more effective medicines.

17 May 2011

China's SFDA approves TPI anti-diabetic drug Gliclazide

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals today announced that TPI has received the China's SFDA's approval for its anti-diabetic drug Gliclazide Tablets.

13 May 2011

Sinovac first quarter sales increase 5.3% to $4.7 million

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited first quarter financial results for the period ended March 31, 2011.

13 May 2011

Trillium raises $1 million to advance TTI-1612 into clinical trials for interstitial cystitis treatment

Trillium Therapeutics Inc., a privately-held biopharmaceutical company, announced today that it has raised $1 million from a new undisclosed investor. The funds will be used to advance its lead program, TTI-1612, into clinical trials for the treatment of interstitial cystitis, also known as bladder pain syndrome. The first trial is projected to start in the second half of this year.

12 May 2011

Miltenyi Biotec enters partnership with TeutoCell to develop novel cell culture techniques

Miltenyi Biotec, the only company to offer a seamless experimental integration path from sample preparation through cell separation, culture, and analysis for primary cells, today entered into a strategic alliance with TeutoCell, a provider of cutting edge cell culture technology.

12 May 2011

CrystalGenomics receives draft CSR for CG400549 Phase I MAD study in Staph infections

CrystalGenomics, Inc., a biopharmaceutical company with 3 clinical stage candidates, has announced today that the draft Clinical Study Report from CG400549's Phase I Multiple Ascending Dose Study has just been received.

12 May 2011

Santaris Pharma advances SPC4955 into Phase 1 trial for high cholesterol treatment

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that it has advanced a second drug from its cardiometabolic program, SPC4955 into Phase 1 clinical trials, for the treatment of high cholesterol.

11 May 2011

ImmunID, Centre Léon Bérard and Cytheris commence CYT107-XELODA Phase IIa trial in metastatic breast cancer

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, the Centre Léon Bérard, the major cancer research and treatment center for the Rhône-Alpes region of France, and ImmunID Technologies SAS, a diagnostic company specialized in innovative immunomonitoring tests and services, today announced initiation of a Phase IIa clinical trial that will evaluate multiple combinations of recombinant human interleukin-7, the investigational multifunctional cytokine under development by Cytheris, and a chemotherapeutic agent, XELODA, in the treatment of metastatic breast cancer.

11 May 2011

Symphogen to present second-generation Sympress platform at ESACT conference

Symphogen, a private biopharmaceutical company developing superior antibody therapeutics to treat cancer, infectious and autoimmune diseases, announced today that second-generation enhancements to the company's SYMPRESS manufacturing and quality control platform will be presented in an oral presentation entitled "Recombinant antibody mixtures; optimization of cell line generation and single-batch manufacturing processes" by Dr. Søren K. Rasmussen, Principal Scientist, Symphogen at the upcoming European Society for Animal Cell Technology conference in Vienna on May 17, 2011.

11 May 2011

Biopharmaceutical News and Research

New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

Sosei to introduce NorLevo oral emergency contraceptive in Japan

CSL welcomes historic pandemic agreement

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Mpex, Synteract partner for cystic fibrosis fundraising event

CITN selects Cytheris' CYT107 for initial clinical trials at network institutions

HII, CDISC launch new project to harmonize health research guidelines

ProBioGen, Life Technologies' new cell line development kits now available for biologic drug production

CytRx sells global rights of molecular chaperone assets to Orphazyme

PGT, Quintiles collaborate to bring genomic testing into mainstream drug development

China's SFDA approves TPI anti-diabetic drug Gliclazide

Sinovac first quarter sales increase 5.3% to $4.7 million

Trillium raises $1 million to advance TTI-1612 into clinical trials for interstitial cystitis treatment

Miltenyi Biotec enters partnership with TeutoCell to develop novel cell culture techniques

CrystalGenomics receives draft CSR for CG400549 Phase I MAD study in Staph infections

Santaris Pharma advances SPC4955 into Phase 1 trial for high cholesterol treatment

ImmunID, Centre Léon Bérard and Cytheris commence CYT107-XELODA Phase IIa trial in metastatic breast cancer

Symphogen to present second-generation Sympress platform at ESACT conference

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