Biopharmaceutical News and Research

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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

New fully human monoclonal antibodies to battle Chikungunya

The Singapore Immunology Network (SIgN), an institute of the Agency of Science, Technology and Research (A*STAR), and VIVALIS, a French biopharmaceutical company, announced today the discovery of two new fully human monoclonal antibodies which could battle Chikungunya, a disease that currently has no available vaccine or specific treatment.

16 Feb 2011

WaferGen offers SNP Genotyping screening with new SmartChip PCR System

WaferGen Biosystems, Inc. a leading developer of state-of-the-art genomic analysis systems, today announced that it is offering an early access program for high-throughput Single Nucleotide Polymorphism Genotyping through its new SmartChip Real-Time PCR System.

16 Feb 2011

Bioniche presentation focuses on implementing E. coli cattle vaccine to reduce risk of human infection

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, gave a presentation about its E. coli O157 cattle vaccine at the First International One Health Congress in Melbourne, Victoria, Australia.

16 Feb 2011

Pfenex enters strategic agreement with Boehringer Ingelheim for use of Expression Technology

Pfenex Inc., an industry leader in protein expression through the Pfenex Expression Technology platform and Boehringer Ingelheim International GmbH, a leading pharmaceutical company and global leader in biopharmaceutical contract development and manufacture, announced today that they have entered into a strategic agreement.

16 Feb 2011

Aeolus receives BARDA contract for AEOL 10150 drug development against ARS

Aeolus Pharmaceuticals, a biopharmaceutical company developing a new class of broad spectrum catalytic antioxidant compounds that reduce oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure, today announced that the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, has awarded Aeolus a contract for the advanced development of AEOL 10150 as a medical countermeasure against the pulmonary sub-syndrome of acute radiation syndrome.

16 Feb 2011

Apricus Bio awards Neopharm exclusive rights to market and sell Vitaros in Israel and Palestinian Territories

Apricus Biosciences, Inc., announced today that it has entered into a licensing agreement granting Neopharm Group the exclusive rights to market and sell Vitaros®, Apricus Bio's treatment for erectile dysfunction ("ED") and, when and if available, its formulation for the treatment of premature ejaculation ("PE"), in Israel and the Palestinian Territories of the Gaza Strip and the West Bank.

15 Feb 2011

Tianyin Pharmaceutical's second quarter revenue increases 69.6% to $25.3 million

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine, branded generics and other pharmaceuticals, announced the financial results for the second quarter of Fiscal Year 2011.

14 Feb 2011

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

For the biopharmaceutical industry, the changing healthcare marketplace has increased the importance - and difficulty - of interacting with patients to improve outcomes. New technologies and access restrictions have created both opportunities and challenges for approaching and engaging patient populations to improve disease control.

14 Feb 2011

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has entered into a Cooperative Research and Development Agreement with the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) to collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer.

14 Feb 2011

Dyadic issued seventh U.S. patent

Dyadic International, Inc., a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, announced today that it has been issued U.S. Patent No. 7,883,872 entitled, Construction of Highly Efficient Cellulase Compositions for Enzymatic Hydrolysis of Cellulose, by the United States Patent and Trademark Office ("USPTO").

11 Feb 2011

Biopharmaceutical News and Research

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

New fully human monoclonal antibodies to battle Chikungunya

WaferGen offers SNP Genotyping screening with new SmartChip PCR System

Bioniche presentation focuses on implementing E. coli cattle vaccine to reduce risk of human infection

Pfenex enters strategic agreement with Boehringer Ingelheim for use of Expression Technology

Aeolus receives BARDA contract for AEOL 10150 drug development against ARS

Apricus Bio awards Neopharm exclusive rights to market and sell Vitaros in Israel and Palestinian Territories

Tianyin Pharmaceutical's second quarter revenue increases 69.6% to $25.3 million

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

Dyadic issued seventh U.S. patent

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