Biopharmaceutical News and Research

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Recruitment for the Phase IIa clinical trial to assess CNS 7056 sedative completed by PAION

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces the successful completion of the Recruitment for the Phase IIa clinical trial assessing the new short-acting intravenous anesthetic/sedative CNS 7056 in patients undergoing endoscopy of the upper gastrointestinal tract.

8 Sep 2009

Ipsen grants license to Debiopharm for developing and commercialising cancer treatment

Ipsen (Euronext:IPN), an innovation-driven global specialty pharmaceutical Group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced today the signature of an agreement under which Debiopharm is granted an exclusive worldwide license to develop and commercialise Ipsen's first-in-class inhibitor of the CDC25 phosphatase enzyme (now Debio 0931), for the treatment of various human cancers.

7 Sep 2009

Debiopharm granted license to develop and commercialise CDC25

Ipsen, an innovation-driven global specialty pharmaceutical Group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced today the signature of an agreement under which Debiopharm is granted an exclusive worldwide license to develop and commercialise Ipsen’s first-in-class inhibitor of the CDC25 phosphatase enzyme (now Debio 0931), for the treatment of various human cancers.

7 Sep 2009

3Sbio announces date for shareholders' annual general meeting

3SBio Inc.("3SBio" or "Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that the annual general meeting of shareholders of 3SBio Inc. will be held on October 12, 2009 at 10:00 a.m., Shenyang time, at No.3 A1, Road 10, Shenyang Economy & Technology Development Zone, Shenyang 110027, People's Republic of China. The shareholder record date is September 12, 2009.

7 Sep 2009

Sinovac to purchase H1N1 vaccine for the national stockpiling plan

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the Ministry of Industry and Information Technology of the People's Republic of China has issued the initial order to Sinovac to purchase H1N1 vaccine for the national stockpiling plan.

5 Sep 2009

Securities class action lawsuit filed against Repros Therapeutics

Feazell & Tighe, L.L.P. announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of Texas on behalf of all persons or entities who purchased or otherwise acquired the common stock of Repros Therapeutics Inc. (“Repros” or the “Company”) (Nasdaq:RPRX), between July 1, 2009 and August 3, 2009, inclusive (the “Class Period”).

5 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

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