Biopharmaceutical News and Research

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Navidea commences enrollment in NAV4694 Phase 2b study to detect erebral β-amyloid plaque

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment.

28 Mar 2013

FDA clears Soligenix's IND application for SGX942 for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration has completed its review and cleared the Investigational New Drug application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

27 Mar 2013

Lightlake to present Phase II clinical trial results of opioid antagonist nasal spray at APA Annual Meeting

Lightlake Therapeutics Inc., an early stage biopharmaceutical company developing addiction treatments, announced today that a scientific abstract based on results of the Company's Phase II clinical trial of its opioid antagonist nasal spray treatment for patients with Binge Eating Disorder has been accepted for presentation at the American Psychiatric Association Annual Meeting taking place in San Francisco, California, May 18-22, 2013.

27 Mar 2013

Auxilium Pharmaceuticals reports positive results from phase IIa Frozen Shoulder Syndrome clinical trial

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive data for collagenase clostridium histolyticum or CCH which is being developed for the potential treatment, if approved by the U.S. Food and Drug Administration, of adult patients with adhesive capsulitis, commonly known as Frozen Shoulder syndrome.

26 Mar 2013

arGEN-X advances ARGX-112 into formal preclinical development

arGEN-X, a clinical stage biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announces that it has progressed ARGX-112, its fourth therapeutic candidate, into formal preclinical development.

25 Mar 2013

Epizyme receives patent for drug candidate for genetically defined type of non-Hodgkin lymphomas

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today that it has received a Notice of Issuance from the U.S. Patent and Trademark Office for its patent application entitled "ARYL-OR HETEROARYL-SUBSTITUTED BENZENE COMPOUNDS", U.S. Patent No.: 8,410,088.

24 Mar 2013

Chimerix receives FDA Fast Track designation for CMX001 to prevent CMV infection

Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection.

12 Mar 2013

Pneumococcal vaccine pre-clinical development supported by £0.2 million award from Biomedical Catalyst

ImmBio (Immunobiology Ltd), a biopharmaceutical company developing innovative vaccines against serious infectious diseases, today announced that the UK government-backed Biomedical Catalyst has awarded the company approximately £0.2 million ($0.3 million) to support pre-clinical development of its pneumococcal vaccine, PnuBioVax™, which targets a wide range of strains of the bacteria.

12 Mar 2013

Sosei commences SO-1105 Phase III trial in oropharyngeal candidiasis

Sosei Group Corporation, the biopharmaceutical company, today announces that its Japanese subsidiary, Sosei Co., Ltd., has initiated a Phase III trial for SO-1105 for the treatment of oropharyngeal candidiasis.

12 Mar 2013

FDA accepts Ampio’s Patient Outcome for Premature Ejaculation questionnaire

Ampio Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat prevalent inflammatory diseases, such as osteoarthritis (Ampion) and diabetic macular edema (Optina) and sexual dysfunction (Zertane) announced FDA acceptance of its POPE questionnaire, a modification of the Premature Ejaculation Profile (PEP) questionnaire that was used in the two successful Zertane Phase 3 clinical trials completed in Europe.

11 Mar 2013

Armetheon plans to develop tecarfarin against prosthetic heart valves or chronic renal dysfunction

Armetheon, Inc., a clinical stage biopharmaceutical company, announced today that it plans to develop its novel oral anti-coagulant (OAC), tecarfarin (ATI-5923), for a patient population which includes those who have prosthetic heart valves or chronic renal dysfunction.

11 Mar 2013

Acceleron commences ACE-536 phase 2 study in beta-thalassemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced the initiation of a phase 2 study of its novel, investigational protein therapeutic, ACE-536, to treat patients with beta-thalassemia, a genetic hematologic disorder causing chronic and life-threatening anemia and serious complications affecting the spleen, liver and heart.

7 Mar 2013

University of Sunderland pharmaceutical scientists receive CFUK grant for research into cystinosis

Pharmaceutical scientists at the University of Sunderland have been awarded £125,000 by the Cystinosis Foundation (CF) UK to fund the next stage of their research into a rare genetic disease.

7 Mar 2013

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced a new supply agreement with Laboratorios Grifols, S.A. for the development, manufacture and supply of commercial quantities of OFIRMEV (acetaminophen) injection in flexible plastic bags.

6 Mar 2013

Cliantha Research chooses Acceliant's eClinical Suite for clinical trial data management needs

Acceliant, a global technology provider of innovative clinical trial data management solutions, today announced that Cliantha Research, a leading global Contract Research Organization, has chosen Acceliant's eClinical Suite for their clinical trial data management needs.

27 Feb 2013

Smoking prevention and cessation campaigns: an interview with Dr DePinho, University of Texas MD Anderson Cancer Center and Dr Mohar, National Cancer Institute of Mexico

There are more than 94 million former and current smokers in the United States, and more than 21 million in Mexico, according to the 2009 Global Adult Tobacco Survey (GATS) Fact Sheet.

27 Feb 2013

Sius single-use tangential flow filtration skid from Novasep

Novasep, a leading supplier of manufacturing solutions to the life sciences industries, today announces the launch of its Sius single-use tangential flow filtration (TFF) skid.

26 Feb 2013

Avaxia initiates AVX-470 Phase 1b clinical study in ulcerative colitis

Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced today that the first patient has been dosed in a Phase 1b clinical study of AVX-470, an oral anti-TNF antibody, for the treatment of ulcerative colitis.

25 Feb 2013

Circassia announces results from ToleroMune cat allergy phase II clinical study

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced the results of a phase II clinical study showing that a short course of just four doses of its ToleroMune cat allergy therapy maintained improvements in patients' symptoms two years after the start of treatment.

25 Feb 2013

Marine-based active substances show promise against multiple myeloma

There is fierce competition in the ocean habitat. In order to survive there, marine organisms defend themselves against their rivals using an entire arsenal of chemical weapons. With the help of these substances they attack hostile cells, overcome their defence system and thus are interesting active substance candidates for cancer research.

22 Feb 2013

Biopharmaceutical News and Research

Navidea commences enrollment in NAV4694 Phase 2b study to detect erebral β-amyloid plaque

FDA clears Soligenix's IND application for SGX942 for treatment of oral mucositis

Lightlake to present Phase II clinical trial results of opioid antagonist nasal spray at APA Annual Meeting

Auxilium Pharmaceuticals reports positive results from phase IIa Frozen Shoulder Syndrome clinical trial

arGEN-X advances ARGX-112 into formal preclinical development

Epizyme receives patent for drug candidate for genetically defined type of non-Hodgkin lymphomas

Chimerix receives FDA Fast Track designation for CMX001 to prevent CMV infection

Pneumococcal vaccine pre-clinical development supported by £0.2 million award from Biomedical Catalyst

Sosei commences SO-1105 Phase III trial in oropharyngeal candidiasis

FDA accepts Ampio’s Patient Outcome for Premature Ejaculation questionnaire

Armetheon plans to develop tecarfarin against prosthetic heart valves or chronic renal dysfunction

Acceleron commences ACE-536 phase 2 study in beta-thalassemia

University of Sunderland pharmaceutical scientists receive CFUK grant for research into cystinosis

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

Cliantha Research chooses Acceliant's eClinical Suite for clinical trial data management needs

Smoking prevention and cessation campaigns: an interview with Dr DePinho, University of Texas MD Anderson Cancer Center and Dr Mohar, National Cancer Institute of Mexico

Sius single-use tangential flow filtration skid from Novasep

Avaxia initiates AVX-470 Phase 1b clinical study in ulcerative colitis

Circassia announces results from ToleroMune cat allergy phase II clinical study

Marine-based active substances show promise against multiple myeloma

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