Biopharmaceutical News and Research

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Ambit to provide overview of quizartinib drug candidate at Barclays Global Healthcare Conference

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the Company's participation at the Barclays Global Healthcare Conference to be held at the Loews Miami Hotel in Miami Beach, FL, March 10-13, 2014.

4 Mar 2014

Arrowhead receives approval to initiate Phase 2a clinical trial of ARC-520 for chronic HBV infection

Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it received regulatory approval to begin a Phase 2a clinical trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus (HBV) infection.

4 Mar 2014

Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer's disease.

4 Mar 2014

OPKO Health consolidated revenues increase about 30% to $20.7 million in Q4 2013

OPKO Health, Inc., a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its 2013 fourth quarter and full year ended December 31, 2013.

4 Mar 2014

Atopix presents positive results of Phase IIb asthma study at AAAAI meeting

Atopix Therapeutics Ltd ("Atopix"), a biopharmaceutical company developing innovative CRTH2 antagonists for allergic disease, announced the results of a Phase IIb asthma study with their lead compound OC459 at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting , San Diego, California, USA on March 1st.

3 Mar 2014

Auxilium Pharmaceuticals’ net revenues increase $125.9M to 56%

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced financial results for the fourth quarter and full year ending December 31, 2013. The Company also highlighted select commercial, regulatory and clinical development progress and future goals and provided financial guidance for 2014.

28 Feb 2014

OrthoTrophix commences TPX-100 Phase 2 clinical study in knee osteoarthritis patients

OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company started a Phase 2 clinical study of its cartilage repair therapeutic agent, TPX-100, with knee osteoarthritis patients in the U.S. The Company also announced that it had successfully closed the second and last tranche of its Series A preferred stock financing.

20 Feb 2014

CAS announces landmark five-year agreement for SciFinder with AstraZeneca

Chemical Abstracts Service, the world's authority for chemical information, announced today a landmark five-year agreement for SciFinder, the choice for chemistry research, with AstraZeneca, a leading biopharmaceutical company specializing in the discovery, development, manufacturing and marketing of prescription medicines. The long-term agreement guarantees AstraZeneca researchers access to the most accurate, comprehensive and current research, available only in SciFinder.

20 Feb 2014

PAREXEL announces launch of new regulatory outsourcing service line for life sciences industry

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced the launch of a new service line designed to provide a focused, market-driven approach to regulatory outsourcing services in the life sciences industry, with a primary emphasis on post-approval regulatory activities.

From Parexel 19 Feb 2014

Eleven Biotherapeutics announces first pivotal Phase 3 clinical study of EBI-005 for treatment of DED

Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that patient randomization and dosing are underway in the Company's first pivotal Phase 3 clinical study of EBI-005 for the treatment of moderate to severe dry eye disease (DED), the OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease).

19 Feb 2014

NPS Pharmaceuticals reports net global product sales of $15.3 million for Q4 2013

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported financial results for 2013 and its financial outlook for 2014.

18 Feb 2014

GENFIT receives FDA Fast Track designation for GFT505 development program in NASH

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces that the Food and Drug Administration has granted Fast Track designation to the GFT505 development program in NASH, with effect from February 14, 2014.

18 Feb 2014

BMG Pharma signs agreement with Samyang Biopharmaceutical to market GelX in South Korea

BMG Pharma S.r.l. today is pleased to announce that it has signed an exclusive distribution agreement with Samyang Biopharmaceutical Corporation granting them the rights to promote, sell and market its novel mucositis management product GelX in the territory of South Korea.

17 Feb 2014

Scientists discover novel antibody-based therapy that targets progression of kidney fibrosis

Scientists from the University of Sheffield have developed a novel antibody-based therapy which targets the progression of life threating kidney fibrosis.

16 Feb 2014

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that the National Institute of Allergy and Infectious Diseases has awarded Soligenix a Small Business Innovation Research grant to support further preclinical development of SGX943 as a treatment for melioidosis.

14 Feb 2014

TPI announces financial results for second quarter fiscal year 2014

Tianyin Pharmaceutical Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) announced financial results for the second quarter fiscal year 2014.

14 Feb 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.

13 Feb 2014

Agenus closes previously announced acquisition of 4-Antibody

Agenus Inc., a biopharmaceutical company developing novel immunotherapeutics, including a portfolio of checkpoint modulators (CPMs), anti-cancer vaccines and adjuvants, today completed the previously announced acquisition of 4-Antibody AG, a private European-based biopharmaceutical company.

13 Feb 2014

FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc., a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.

13 Feb 2014

Alvogen launches Inflectra into Central and Eastern Europe

Alvogen, the multinational pharmaceuticals company, today announced the launch of Inflectra (Infliximab) into Central and Eastern Europe. Inflectra, Europe's first biosimilar monoclonal antibody (mAb) therapy that has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

13 Feb 2014

Biopharmaceutical News and Research

Ambit to provide overview of quizartinib drug candidate at Barclays Global Healthcare Conference

Arrowhead receives approval to initiate Phase 2a clinical trial of ARC-520 for chronic HBV infection

Intra-Cellular Therapies initiates Phase I/II clinical trial to evaluate pharmacokinetics in patients with dementia

OPKO Health consolidated revenues increase about 30% to $20.7 million in Q4 2013

Atopix presents positive results of Phase IIb asthma study at AAAAI meeting

Auxilium Pharmaceuticals’ net revenues increase $125.9M to 56%

OrthoTrophix commences TPX-100 Phase 2 clinical study in knee osteoarthritis patients

CAS announces landmark five-year agreement for SciFinder with AstraZeneca

PAREXEL announces launch of new regulatory outsourcing service line for life sciences industry

Eleven Biotherapeutics announces first pivotal Phase 3 clinical study of EBI-005 for treatment of DED

NPS Pharmaceuticals reports net global product sales of $15.3 million for Q4 2013

GENFIT receives FDA Fast Track designation for GFT505 development program in NASH

BMG Pharma signs agreement with Samyang Biopharmaceutical to market GelX in South Korea

Scientists discover novel antibody-based therapy that targets progression of kidney fibrosis

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

TPI announces financial results for second quarter fiscal year 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Agenus closes previously announced acquisition of 4-Antibody

FDA accepts Regado Biosciences' IND application for REG2

Alvogen launches Inflectra into Central and Eastern Europe

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