Biopharmaceutical News and Research

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New HQ of David H. Koch Institute for Integrative Cancer Research officially dedicated

The new seven-story headquarters of the David H. Koch Institute for Integrative Cancer Research at MIT, where scientists and engineers are working together to pursue new ways to treat, detect and prevent cancer, will be officially dedicated today at 4 p.m.

5 Mar 2011

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II hereditary angioedema (HAE) attacks licensed for self-administration in Europe.

4 Mar 2011

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

3 Mar 2011

Rockwell Medical fourth quarter net loss increases to $1.7 million

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today fourth quarter and full-year 2010 results.

3 Mar 2011

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Protalex, Inc, a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases, today announced enrollment of the first patients in the 3rd cohort of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA) being conducted in South Africa. The dose was increased by a factor of two from the 2nd cohort.

3 Mar 2011

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

In 2010, Group drug sales grew 5.1% year-on-year - at constant currency - exceeding the objective set a year ago of 3.0% to 5.0%, fuelled notably by the sales of Specialty Care products throughout all the geographical regions where the Group operates.

2 Mar 2011

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company utilizing its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune and immune-mediated disease treatments, today announced the successful clearance of an IND with the US FDA for BHT-3034, a disease-modifying DNA plasmid vaccine immunotherapy for patients with the autoimmune neuromuscular junction disease myasthenia gravis.

1 Mar 2011

Santaris licenses miR-33 from MGH to treat cardiovascular disorders

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that the Company has obtained an exclusive license from Massachusetts General Hospital for intellectual property related to the regulation of miR-33 for the treatment of cardiovascular disorders.

1 Mar 2011

HP announces innovative drug research application for its inkjet technology

HP today announced an innovative drug research application for its inkjet technology that enables pharmaceutical companies to more efficiently develop better drugs through vastly more precise dispensing of dosages.

1 Mar 2011

Nile plans to develop novel therapeutics for ADHF

Nile Therapeutics, Inc., a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced plans to pursue a new indication in the field of heart failure.

1 Mar 2011

Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

Omni Bio Pharmaceutical, Inc., an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential, has committed to expand its Phase I/II human clinical trial in recently diagnosed Type 1 diabetes patients from 15 patients to 50.

28 Feb 2011

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

Synageva supports Fourth International Rare Disease Day

Synageva BioPharma Corp., a privately held biopharmaceutical company that is developing therapeutic products for rare disorders, announced today that the company is supporting the Fourth International Rare Disease Day observance on February 28, 2011.

28 Feb 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

FUJIFILM enters definitive agreement to acquire Merck

FUJIFILM Corporation and Merck, known as MSD outside the United States and Canada, today announced they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceutical industry and wholly owned by Merck.

28 Feb 2011

Samsung enters strategic partnership with Quintiles to support biopharmaceuticals market

Samsung Electronics Co., Ltd., the world's largest electronics company, and its affiliated companies have entered into a strategic partnership with Quintiles, the world's leading pharmaceutical services company, to support Samsung's entry into the biopharmaceuticals market, Quintiles announced today.

27 Feb 2011

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that encouraging preliminary results of a Phase 2 trial of ganetespib as a single agent in non-small cell lung cancer were presented at the International Association for the Study of Lung Cancer 11th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.

27 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Stemline licenses clinically active oncology vaccine for dual targeting of tumor bulk and cancer stem cells

Stemline Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel oncology compounds that target cancer stem cells (CSCs), today announced that it holds the license, from the University of Pittsburgh ("Pitt"), for the exclusive worldwide rights to a clinically active oncology vaccine directed to multiple defined targets on tumor bulk and CSCs.

25 Feb 2011

Thermo Fisher to sell Athena Diagnostics and Lancaster Labs businesses for $940 million

Thermo Fisher Scientific Inc., the world leader in serving science, announced today that it has signed definitive agreements to sell its Athena Diagnostics and Lancaster Laboratories businesses for a total of $940 million in cash.

From Thermo Fisher Scientific Inc. 24 Feb 2011

Biopharmaceutical News and Research

New HQ of David H. Koch Institute for Integrative Cancer Research officially dedicated

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Rockwell Medical fourth quarter net loss increases to $1.7 million

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Santaris licenses miR-33 from MGH to treat cardiovascular disorders

HP announces innovative drug research application for its inkjet technology

Nile plans to develop novel therapeutics for ADHF

Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

Synageva supports Fourth International Rare Disease Day

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

FUJIFILM enters definitive agreement to acquire Merck

Samsung enters strategic partnership with Quintiles to support biopharmaceuticals market

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

AMAG fourth quarter total revenues increase to $17.2 million

Stemline licenses clinically active oncology vaccine for dual targeting of tumor bulk and cancer stem cells

Thermo Fisher to sell Athena Diagnostics and Lancaster Labs businesses for $940 million

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