Biopharmaceutical News and Research

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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

iPierian to participate in $3.7 million NIH grant awarded to The Johns Hopkins University

iPierian, Inc., a biopharmaceutical company focused on changing the paradigm of drug discovery and development through the application of cellular reprogramming, today announced that it has been selected to participate in a $3.7 million National Institutes of Health (NIH) Grand Opportunities (GO) grant awarded to The Johns Hopkins University.

22 Oct 2009

NIH awards $3.7 million to Johns Hopkins scientists for research on stem cells developed from ALS patients' skin

Johns Hopkins scientists have been awarded a $3.7 million grant from the National Institutes of Health (NIH) to learn more about the nerve and muscle-wasting disease amyotrophic lateral sclerosis (ALS) using stem cells developed from ALS patients' skin. The award, given over a two-year span, will be shared with three other laboratories, including one at Harvard University and two at Columbia University.

22 Oct 2009

Laureate Pharma signs development and manufacturing agreement to develop fusion protein products

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has signed a new Biopharmaceutical Development and Manufacturing Agreement with an undisclosed client.

22 Oct 2009

Shire to file a Biologics License Application for REPLAGAL with the FDA

Shire plc, the global specialty biopharmaceutical company, announces plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of the year.

21 Oct 2009

Logical Therapeutics to present its clinical study results on LT-NS001

Logical Therapeutics, Inc. (Logical), a biopharmaceutical company focused on developing products that treat medical conditions associated with inflammation, has been selected to present the results of its clinical study comparing the gastrointestinal (GI) safety of its lead product LT-NS001, vs. naproxen at the American College of Gastroenterology's (ACG) Annual Scientific Meeting on October 27, 2009.

21 Oct 2009

Targacept presents data from Phase 2b clinical trial of TC-5214

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics-, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide.

20 Oct 2009

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in CNS and oncology, today announced top-line results from a Phase IIa clinical study of Serdaxin™, its major depressive disorder (MDD) drug candidate.

20 Oct 2009

PhRMA report says nearly 1,000 life-changing medicines for diseases affecting women in development

America's pharmaceutical research and biotechnology companies are working on nearly 1,000 life-changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the U.S. Food and Drug Administration or are in human clinical trials.

20 Oct 2009

New technique to treat metabolic disorders in babies while still in the womb

Researchers say a new development in cord blood transplants for inherited metabolic disorders may be curative for some babies who are treated while still in the womb.

20 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma.

19 Oct 2009

Pfizer announces it has combined operations with Wyeth following the closing of the acquisition

Pfizer Inc today announced that it has combined operations with Wyeth following the closing of the acquisition yesterday. Pfizer is now a more diversified health care company, with product offerings in human, animal, and consumer health, including vaccines, biologics, small molecules and nutrition across the developed and emerging markets.

19 Oct 2009

PIKAMAB obtains U.S. patent rights to develop theragnostic product

PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it has secured exclusive rights to two issued U.S. patents from Hospital for Special Surgery, New York. PIKAMAB is developing Lupus TherasightTM, a novel theragnostic product that will eventually help guide the drug development process and patient treatment protocols in the areas of lupus and lupus nephritis.

15 Oct 2009

Co-promotion agreement to promote Prosed DS to urologists and retail pharmacists

Timm Medical Technologies, Inc., a specialist Urology company, announced today its exclusive co-promotion agreement with Ferring Pharmaceuticals Inc., a Swiss-based biopharmaceutical company, for Prosed® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate) in the United States.

15 Oct 2009

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL).

15 Oct 2009

IQPC to hold the 8th Annual Polymorphism & Crystallization Scientific Forum

Organized by IQPC, the 8th Annual Polymorphism & Crystallization Scientific Forum will be held October 26-28, 2009 at the Hub Cira Center in Philadelphia, PA (www.polymorphismforum.com).

From IQPC Ltd 15 Oct 2009

Eden Biodesign to manufacture Biotecnol's Cardiotrophin-1

Eden Biodesign, a globally-integrated provider of biopharmaceutical process development, cGMP manufacturing and consultancy services, today announced it has been selected by Biotecnol SA to manufacture Cardiotrophin-1 for potential use in certain liver indications.

15 Oct 2009

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has expanded its compassionate use program for PV-10, making the agent, which is being developed as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients in the United States. The program is already in progress in Australia, where it was initiated in June 2009.

14 Oct 2009

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Progenics Pharmaceuticals, Inc. today announced that it has entered into an agreement with Wyeth Pharmaceuticals, a division of Wyeth under which Progenics is regaining all worldwide rights to the RELISTOR® franchise from Wyeth Pharmaceuticals, which Progenics had previously licensed to Wyeth Pharmaceuticals.

14 Oct 2009

Biopharmaceutical News and Research

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

iPierian to participate in $3.7 million NIH grant awarded to The Johns Hopkins University

NIH awards $3.7 million to Johns Hopkins scientists for research on stem cells developed from ALS patients' skin

Laureate Pharma signs development and manufacturing agreement to develop fusion protein products

Shire to file a Biologics License Application for REPLAGAL with the FDA

Logical Therapeutics to present its clinical study results on LT-NS001

Targacept presents data from Phase 2b clinical trial of TC-5214

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

PhRMA report says nearly 1,000 life-changing medicines for diseases affecting women in development

New technique to treat metabolic disorders in babies while still in the womb

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

Pfizer announces it has combined operations with Wyeth following the closing of the acquisition

PIKAMAB obtains U.S. patent rights to develop theragnostic product

Co-promotion agreement to promote Prosed DS to urologists and retail pharmacists

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

IQPC to hold the 8th Annual Polymorphism & Crystallization Scientific Forum

Eden Biodesign to manufacture Biotecnol's Cardiotrophin-1

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Biotechnology 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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