Biopharmaceutical News and Research

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INSPIRE Phase I/IIa study data to be presented at ICAAC

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that data from an interim analysis of its INSPIRE Phase I/IIa study of HIV-infected patients with low CD4 T cell counts treated with a three injection cycle of the Company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), will be presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held September 12-15, 2009, in San Francisco, CA.

9 Sep 2009

Laureate Pharma and Neoprobe sign manufacturing agreement

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, and Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that they have entered into a Biopharmaceutical Development and Manufacturing Agreement.

9 Sep 2009

Can-Fite's Phase II clinical study of CF101 provides positive results

Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, an Israeli Biopharmaceutical company, announced today that its 75-patient Phase II clinical study with CF101 to treat patients with moderate to severe Psoriasis has successfully met its primary objectives.

9 Sep 2009

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S.

8 Sep 2009

Haemonetics acquires SEBRA's blood collection and processing business

Haemonetics Corporation, a global blood management solutions company, and Engineering and Research Associates Inc. (known as "SEBRA(R)"), a leading provider of blood and medical manufacturing technologies, announced today that Haemonetics has acquired the assets of SEBRA's blood collection and processing business for $12.5 million cash. The acquisition is expected to close within the next several weeks.

8 Sep 2009

Shire's assistance helps Gaucher patients manage imiglucerase supply shortage

Shire plc, the global specialty biopharmaceutical company, is committed to doing everything possible to assist Gaucher patients and their physicians during the imiglucerase supply shortage. Shire is pleased to be able to provide velaglucerase alfa well over a year ahead of previously anticipated commercial launch world wide.

8 Sep 2009

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