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Managing costs for clinical trials is a big challenge

In the drug industry, clinical trials carry price tags that run well into the tens of millions of dollars. Managing such costs demands a sure hand, and trial sponsors go to great lengths to monitor and manage funds allocated to vendors.

1 Sep 2009

New Vice President for Bioanalytical Development lab appointed by Cytovance Biologics

Cytovance Biologics LLC, a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from mammalian cell culture, today announced the addition of Dr. Jeffrey Su as Vice President of Bioanalytical Development to its diverse and growing scientific staff. Dr. Su will head up the state of the art Bioanalytical Development laboratory supporting existing and new client needs.

1 Sep 2009

Sinovac to supply its Anflu seasonal flu vaccine to the Beijing Public Health Bureau

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the Beijing Public Health Bureau has selected Sinovac as one of the four manufacturers to supply Anflu(R), Sinovac's seasonal influenza vaccine, for the benefit of the citizens of Beijing. The Beijing Public Health Bureau completed the bidding process for the purchase of flu vaccines and corresponding services for 2009 on August 26, 2009. The agreement will be executed after the public notice period.

28 Aug 2009

Arno Therapeutics to commence Phase 1 clinical study of AR-12 in adult patients with lymphoma

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced the dosing of the first patient in a Phase I clinical study of AR-12 (formerly OSU-03012) in adult patients with advanced or recurrent solid tumors or lymphoma.

28 Aug 2009

New Associate Director of Business Development appointed by ERT

ERT, announced the appointment of a new Associate Director of Business Development - Japan, Miki Stevens. In this new role, Ms. Stevens will work with ERT's Japanese partner, Site Support Institute (SSI), to facilitate sales activities and to provide enhanced in-country support of Japanese sponsors and clinical trial sites.

27 Aug 2009

Lakewood-Amedex to speed up development of its broad spectrum anti-influenza product into clinical studies

Lakewood-Amedex Inc., (L-A), the anti-infectives biopharmaceutical company developing a unique portfolio of anti-bacterial and anti-viral products including NuBiotics, a novel family of synthetic anti-bacterial compounds, and anti-viral products against hepatitis, HIV and influenza, announced today that it is accelerating development of its broad spectrum anti-influenza product into clinical studies.

27 Aug 2009

Novelos Therapeutics enters into a definitive agreement with Purdue Pharma to raise funds

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos entered into a definitive agreement with Purdue Pharma L.P., an existing investor, to sell 13,636,364 shares of its common stock and warrants, expiring on December 31, 2015, to purchase an aggregate of approximately 4,772,728 shares of common stock at an exercise price of $0.66 per share, for gross proceeds of $9 million.

27 Aug 2009

Morria Biopharmaceuticals receives approval to commence its Phase II clinical trial on MRX6

Morria Biopharmaceuticals Plc, a biopharmaceutical company focusing on novel, non-steroidal anti-inflammatory drugs, announced today that it has received written approval to commence its Phase II clinical trial on its leading topical Multi-Functional Anti Inflammatory Drug (MFAID) MRX6.

26 Aug 2009

Tikcro Technologies announces financial results for the second-quarter ended June 30, 2009

Tikcro Technologies Ltd. (OTC BB: TIKRF) today reported results for the second quarter and six months ended June 30, 2009.

26 Aug 2009

Profectus BioSciences to conduct proof-of-concept studies with its rVSV vector technology

Profectus BioSciences, Inc. (Profectus), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, announced today it has entered into a research collaboration agreement with the PATH Malaria Vaccine Initiative (MVI) to conduct proof-of-concept studies with its proprietary, recombinant vesicular stomatitis virus (rVSV) vector technology as a preventative malaria vaccine.

26 Aug 2009

DATATRAK International signs two new studies with a global research-based biopharmaceutical company

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the signing of two new studies with a global research-based biopharmaceutical company.

25 Aug 2009

Shire collaborates with Santaris Pharma to develop Locked Nucleic Acid technology

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces today that it has entered into a research-based collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid (LNA) technology in a range of rare diseases, thereby enabling Shire to build on its already strong competitive position for its Human Genetic Therapies (HGT) business.

25 Aug 2009

Cytrx’s study offers a better perception of arimoclomol's mechanism of action in induced animal stroke

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that study results demonstrated that arimoclomol exhibited both statistically significant neuroprotective and neuroregenerative effects in brain cells of animals induced with stroke, offering important insights into this drug candidate’s mechanism of action.

25 Aug 2009

Bioniche Life Sciences update on Phase III clinical program for evaluating Urocidin

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer.

24 Aug 2009

Santaris Pharma to discover and develop new RNA-based medicines for treating rare genetic disorders

Santaris Pharma A/S, a privately-held biopharmaceutical company focused on developing RNA-based drugs targeted to disease-related mRNAs and microRNAs, today announced a multi-year worldwide strategic alliance with Shire plc to discover and develop new RNA-based medicines to treat rare genetic disorders.

24 Aug 2009

Profibrix raises funds for clinical and preclinical development

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the successful closing of a US $11 million series B investment. The financing round was led by new investor Gilde Healthcare Partners, a leading European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company's Supervisory Board.

24 Aug 2009

Poniard Pharmaceuticals may sell up to $60 million of its registered common stock to finance its picoplatin clinical development and commercialization programs

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20 Aug 2009

John R. Walsh to be responsible for continued expansion of IMS' payer and government solution initiatives

IMS Health today announced that John R. Walsh has been named senior vice president, Payer and Government Solutions, a new position. Previously, Walsh was senior vice president, Strategy and Business Development for IMS. He continues to report to David R. Carlucci, IMS chairman and CEO, and will be based in Norwalk, CT.

20 Aug 2009

Orient Pharma granted commercialization rights for a drug candidate by DURECT

DURECT Corporation today announced that it has signed a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT's ORADUR(R) Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD).

19 Aug 2009

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

SynCo Bio Partners, a Netherlands based biopharmaceutical contract manufacturer, and Versartis, Inc. today announced a strategic partnership to produce Versartis' lead drug candidate VRS-859, a novel GLP-1 analog for monthly dosing to treat type 2 diabetes Under the agreement, SynCo will further develop the Versartis existing production process for VRS-859 and optimize the manufacturing process to increase yields for the forthcoming cGMP production.

18 Aug 2009

Biopharmaceutical News and Research

Managing costs for clinical trials is a big challenge

New Vice President for Bioanalytical Development lab appointed by Cytovance Biologics

Sinovac to supply its Anflu seasonal flu vaccine to the Beijing Public Health Bureau

Arno Therapeutics to commence Phase 1 clinical study of AR-12 in adult patients with lymphoma

New Associate Director of Business Development appointed by ERT

Lakewood-Amedex to speed up development of its broad spectrum anti-influenza product into clinical studies

Novelos Therapeutics enters into a definitive agreement with Purdue Pharma to raise funds

Morria Biopharmaceuticals receives approval to commence its Phase II clinical trial on MRX6

Tikcro Technologies announces financial results for the second-quarter ended June 30, 2009

Profectus BioSciences to conduct proof-of-concept studies with its rVSV vector technology

DATATRAK International signs two new studies with a global research-based biopharmaceutical company

Shire collaborates with Santaris Pharma to develop Locked Nucleic Acid technology

Cytrx’s study offers a better perception of arimoclomol's mechanism of action in induced animal stroke

Bioniche Life Sciences update on Phase III clinical program for evaluating Urocidin

Santaris Pharma to discover and develop new RNA-based medicines for treating rare genetic disorders

Profibrix raises funds for clinical and preclinical development

Poniard Pharmaceuticals may sell up to $60 million of its registered common stock to finance its picoplatin clinical development and commercialization programs

John R. Walsh to be responsible for continued expansion of IMS' payer and government solution initiatives

Orient Pharma granted commercialization rights for a drug candidate by DURECT

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

Oxygen Measurement eBook - Easily Understand Dissolved Oxygen Measurement eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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

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