Biopharmaceutical News and Research

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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

PhRMA: 460 medicines in development for rare diseases

America's biopharmaceutical research companies are intensifying research into rare diseases, which often are among the most devastating to patients and complex for researchers. A record 460 medicines for rare diseases are in late stages of the pipeline, either in clinical trials or awaiting Food and Drug Administration (FDA) review, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).

24 Feb 2011

PCI Biotech completes patient inclusion in PC-A11 phase I/II study to treat cancer

PCI Biotech the Norwegian biopharmaceutical company, reported today that it has completed the inclusion of patients in its phase I/II study of its lead candidate PC-A11 in cancer patients.

23 Feb 2011

Japan MHLW approves Sosei's NorLevo emergency contraceptive pill

Sosei Group Corporation, the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, was granted approval for its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, by the Japan Ministry of Health, Labour and Welfare (MHLW). NorLevo(R) has thus become the fist emergency contraceptive pill available in Japan.

23 Feb 2011

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema.

22 Feb 2011

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

ADVANCELL, an emerging biopharmaceutical company, today announced positive results from a clinical study conducted with Acadra (Acadesine) in Chronic Lymphocytic Leukemia patients resistant to current therapies. The company also announced promising non-clinical results in Multiple Myeloma (MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders. Synergism of Acadra in combination with current treatment in these indications has been demonstrated.

21 Feb 2011

Sheffield Bio-Science forms strategic alliance with Wockhardt to strengthen cell culture media portfolio

Sheffield Bio-Science, a Kerry Group Business, has formed a strategic global sales, marketing and development alliance with Wockhardt Ltd. Under this partnership, Sheffield Bio-Science will be the Exclusive Global Sales and Distribution Partner for recombinant insulin manufactured by global Indian biotech Wockhardt. According to estimates, the potential in cell culture markets is around US$ 50 million.

21 Feb 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Novavax, a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials.

19 Feb 2011

Merck Canada announces $6.8 million investment in AmorChem for biopharmaceutical research

Merck Canada announced today a $6.8 million investment in AmorChem, a Quebec life sciences venture capital fund. This is the latest investment made by Merck following a commitment made in 2010 to invest an incremental $100 million over five years in biopharmaceutical research and development in Quebec.

19 Feb 2011

FDA grants miRagen's MGN-4893 orphan drug designation for treatment of polycythemia vera

miRagen Therapeutics, Inc., a privately-held biopharmaceutical company focused on improving patients' lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's compound MGN-4893 for the treatment of polycythemia vera, a myeloproliferative disease characterized by an overabundance of blood cells and platelets in the body.

18 Feb 2011

First evidence of neurotrophic factors improving status of degenerating dopamine neurons in Parkinson's brains

Ceregene, Inc., a biopharmaceutical company, reported today that its scientists and collaborators have published new experimental findings in support of its Parkinson's disease program which appeared as the lead article in the current issue of Movement Disorders. The publication reports the first evidence that gene transfer can provide targeted expression of a neurotrophic factor, i.e., neurturin or NRTN, intended to restore and preserve dying neurons.

17 Feb 2011

Biopharmaceutical News and Research

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

PhRMA: 460 medicines in development for rare diseases

PCI Biotech completes patient inclusion in PC-A11 phase I/II study to treat cancer

Japan MHLW approves Sosei's NorLevo emergency contraceptive pill

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

Sheffield Bio-Science forms strategic alliance with Wockhardt to strengthen cell culture media portfolio

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Merck Canada announces $6.8 million investment in AmorChem for biopharmaceutical research

FDA grants miRagen's MGN-4893 orphan drug designation for treatment of polycythemia vera

First evidence of neurotrophic factors improving status of degenerating dopamine neurons in Parkinson's brains

Event guide: The 5th mRNA-Based Therapeutics Summit Europe eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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