Biopharmaceutical News and Research

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Dr Lluis Quintana-Murci from the Institut Pasteur in France honoured with the Debiopharm Life Sciences Award

Debiopharm Group, SA (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today presented the 'Debiopharm Life Sciences Award' to Dr Lluis Quintana-Murci from the Institut Pasteur in France, for his outstanding innovative research in the emerging field of evolutionary genetics of infection.

4 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

SFDA approves production license for Sinovac's H1N1 vaccine

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

4 Sep 2009

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

ERT (Nasdaq: ERES) has celebrated a significant milestone by completing its 150th thorough QT clinical Trial (TET). ERT provides full TET support to the biopharmaceutical industry, including consultation, study design, and provision of ECG equipment to ECG analysis, data processing, management, reconciliation, reporting, quality control and regulatory support.

4 Sep 2009

Pfizer finalizes settlement agreement with U.S. DOJ regarding past promotional practices

Pfizer Inc today announced that it has finalized a previously reported agreement in principle with the U.S. Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005.

3 Sep 2009

CORD I phase III clinical trial results of XIAFLEX published

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that The New England Journal of Medicine (NEJM) has published in its September 3rd edition, the Company's pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum) a novel, first-in-class, biologic for the nonsurgical treatment of Dupuytren's contracture.

3 Sep 2009

Sinovac Biotech signs marketing agreement with Boryung Pharmaceutical Company

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has signed an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac's H1N1 vaccine.

3 Sep 2009

Phase 1 single dose clinical trial of Acceleron Pharma's ACE-031 increases lean body mass

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial indicating that ACE-031 was safe and well-tolerated at all dose levels and increased lean body mass.

2 Sep 2009

Single-dose H1N1 vaccine wins approval in China

The Chinese biopharmaceutical company Sinovac Biotech Ltd. on Monday announced its H1N1 (swine) flu vaccine won the approval of a panel of experts from China's State Food and Drug Administration, the Associated Press/Forbes reports. The company expects to obtain a production license later this week. According to the company, clinical trials of the H1N1 vaccine showed a single shot produced an immune response capable of protecting against H1N1 (8/31).

2 Sep 2009

Dr. Raman Bedi to exclusively represent Oragenics' oral care products

Florida-based biopharmaceutical leader Oragenics, Inc. has appointed renowned international oral care authority Dr. Raman Bedi to serve as exclusive representative for the company’s award-winning line of oral care products to the Middle East.

1 Sep 2009

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

Biopharmaceutical News and Research

Dr Lluis Quintana-Murci from the Institut Pasteur in France honoured with the Debiopharm Life Sciences Award

Phase III clinical trial results of XIAFLEX published in a journal

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

SFDA approves production license for Sinovac's H1N1 vaccine

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

Pfizer finalizes settlement agreement with U.S. DOJ regarding past promotional practices

CORD I phase III clinical trial results of XIAFLEX published

Sinovac Biotech signs marketing agreement with Boryung Pharmaceutical Company

Phase 1 single dose clinical trial of Acceleron Pharma's ACE-031 increases lean body mass

Single-dose H1N1 vaccine wins approval in China

Dr. Raman Bedi to exclusively represent Oragenics' oral care products

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

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