Biopharmaceutical News and Research

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Positive results from Logical Therapeutics' Phase I/II LT-NS001 clinical study

Logical Therapeutics, Inc., a Waltham, MA-based biopharmaceutical company announced today the positive results of a Phase I/II clinical trial evaluating the gastrointestinal (GI) safety of its investigational drug LT-NS001, the first of a new class of bio-activated prodrugs being developed for the chronic treatment of arthritic conditions.

27 Oct 2009

Lexicon Pharmaceuticals reports fiscal 2009 third-quarter results and updates of its clinical trials

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and nine months ended September 30, 2009.

27 Oct 2009

Phase 3 trial results of Horizon Therapeutics's HZT-501 presented at the ACG meeting

Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today presented an analysis from two pivotal Phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine.

27 Oct 2009

Shire reports results of Lialda and 5-ASA persistency analyses

Shire plc, the global specialty biopharmaceutical company, presented the results of three 5-aminosalicylic acid (5-ASA) persistency analyses at ACG 2009 Annual Scientific Meeting, evaluating persistency of Lialda® (mesalamine), Asacol® (mesalamine), Pentasa® (mesalamine) (250mg and 500mg), balsalazide [combined results from generic balsalazide disodium and Colazal® (balsalazide disodium)], and Dipentum® (olsalazine sodium) (500mg).

27 Oct 2009

Analysis from Phase 3 trials of HZT-501 presented at 74th ACG meeting

26 Oct 2009

Wound Management Technologies signs distribution agreement with Biocure S.r.l. of Milan

Wound Management Technologies, Inc., through its subsidiary, Wound Care Innovations, announced today that it has reached an agreement with Biocure S.r.l. of Milan, Italy for the distribution of WNDM's patented molecular form of activated collagen, CellerateRx®.

26 Oct 2009

Cephalon, BDC sign option agreement

Cephalon, Inc. and BioAssets Development Corporation (BDC), a privately held biopharmaceutical company, today announced that the companies have signed an agreement that will provide Cephalon with an option to acquire BDC.

26 Oct 2009

Santarus to present results from two investigator-initiated studies with ZEGERID at 2009 ACG meeting

Santarus, Inc., a specialty biopharmaceutical company, today announced that positive data from two investigator-initiated studies with ZEGERID® (omeprazole/sodium bicarbonate) will be presented in poster sessions at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting taking place in San Diego. These studies were supported by grants from Santarus.

26 Oct 2009

FDA grants five-year New Chemical Entity exclusivity to VYVANSE

Shire plc, the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

26 Oct 2009

Aeterna Zentaris raises US$5.1 million from institutional investors

AEterna Zentaris Inc., (the "Company") a global biopharmaceutical company focused on endocrine therapy and oncology, announced today that it has completed its previously announced registered direct offering of US$5.5 million of units comprised of common shares and common share purchase warrants to certain institutional investors.

24 Oct 2009

Medgenics signs $7 million agreement to develop the Biopump technology for Factor VIII

Medgenics is pleased to announce that it has signed a preclinical development and option agreement with a major international biopharmaceutical company that is a market leader in the field of hemophilia.

23 Oct 2009

Shire announces new pharmacokinetic data of ADHD medication

Shire plc, the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.

23 Oct 2009

Sinovac Biotech to distribute PANFLU.1 vaccine in Mexico

Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, today announced that it has received a Certificate of Approval from the Secretaria de Salud to distribute PANFLU.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico. The certificate is valid through October 13, 2014.

23 Oct 2009

Bristol-Myers Squibb reports strong sales and earnings growth for third quarter 2009

Bristol-Myers Squibb Company today reported strong sales and earnings growth for the third quarter 2009.

22 Oct 2009

PAREXEL to present key trends in late phase development and Comparative Effectiveness Research

Experts from PAREXEL International Corporation, a leading global biopharmaceutical services provider, will address key trends in late phase development and Comparative Effectiveness Research at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 12th Annual European Congress, to be held from October 24 - 27, 2009 in Paris, France.

From Parexel 22 Oct 2009

Sartorius reports financial results for the third quarter of 2009

Today Sartorius, a leading international process and laboratory technology provider, reported its nine-month results for 2009. Third-quarter business of both Group divisions showed a highly divergent pattern of development, similar to that in the previous quarters.

From Sartorius 22 Oct 2009

Unilife Medical Solutions to market its products at pharmaceutical industry event

Unilife Medical Solutions Limited today announced it will be exhibiting at two upcoming pharmaceutical trade shows and conferences.

22 Oct 2009

Complex issue of CER in biopharmaceutical development explored

In a new report released today, John Doyle, Vice President and Practice Leader for Quintiles Consulting, and an expert on pharmaceutical market access, explores the complex issue of comparative effectiveness research (CER) and its strategic importance in successful and efficient biopharmaceutical development.

22 Oct 2009

SNAP Diagnostics joins SAFE-BioPharma Association

SNAP Diagnostics, a Chicago-based leader in the development of technology for the detection of sleep apnea and the analysis of snoring patterns, has joined SAFE-BioPharma Association, the non-profit association that created and manages the global SAFE-BioPharma® digital identity and signature standard for the pharmaceutical and healthcare industries. SNAP Diagnostics is the first dedicated device and diagnostics company to join SAFE-BioPharma.

22 Oct 2009

Dose optimization data from Tolerx's Phase 2 clinical study of otelixizumab

Tolerx, Inc., a biopharmaceutical company developing novel therapies intended to treat diabetes, other autoimmune diseases and cancer by specifically modulating T-cell activity, today presented dose optimization data from its Phase 2 clinical study of otelixizumab in subjects with type 1 diabetes. Otelixizumab is a targeted T-cell immunomodulator currently being evaluated in DEFEND, a Phase 3 clinical study in subjects with new-onset autoimmune type 1 diabetes.

22 Oct 2009

Biopharmaceutical News and Research

Positive results from Logical Therapeutics' Phase I/II LT-NS001 clinical study

Lexicon Pharmaceuticals reports fiscal 2009 third-quarter results and updates of its clinical trials

Phase 3 trial results of Horizon Therapeutics's HZT-501 presented at the ACG meeting

Shire reports results of Lialda and 5-ASA persistency analyses

Analysis from Phase 3 trials of HZT-501 presented at 74th ACG meeting

Wound Management Technologies signs distribution agreement with Biocure S.r.l. of Milan

Cephalon, BDC sign option agreement

Santarus to present results from two investigator-initiated studies with ZEGERID at 2009 ACG meeting

FDA grants five-year New Chemical Entity exclusivity to VYVANSE

Aeterna Zentaris raises US$5.1 million from institutional investors

Medgenics signs $7 million agreement to develop the Biopump technology for Factor VIII

Shire announces new pharmacokinetic data of ADHD medication

Sinovac Biotech to distribute PANFLU.1 vaccine in Mexico

Bristol-Myers Squibb reports strong sales and earnings growth for third quarter 2009

PAREXEL to present key trends in late phase development and Comparative Effectiveness Research

Sartorius reports financial results for the third quarter of 2009

Unilife Medical Solutions to market its products at pharmaceutical industry event

Complex issue of CER in biopharmaceutical development explored

SNAP Diagnostics joins SAFE-BioPharma Association

Dose optimization data from Tolerx's Phase 2 clinical study of otelixizumab

Oxygen Measurement eBook - Easily Understand Dissolved Oxygen Measurement eBook

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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