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Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 1b clinical study of PRM-151 to explore the safety, tolerability, pharmacokinetics, and phamacodynamics of PRM-151 in the treatment of patients with idiopathic pulmonary fibrosis.

11 Feb 2011

Intellikine, PKD Foundation to investigate novel therapies for patients with PKD

Intellikine, a leader in the development of small molecule drugs targeting the PI3K/mTOR pathway, and the PKD Foundation today announced a collaboration to investigate novel, orally-available small molecule kinase inhibitors of the TORC1 and TORC2 complexes as a potential treatment for patients with polycystic kidney disease.

11 Feb 2011

Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.

10 Feb 2011

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer. Tesetaxel, the leading oral taxane in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.

10 Feb 2011

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

BioCryst Pharmaceuticals, Inc. announced financial results for the fourth quarter and full year ended December 31, 2010.

10 Feb 2011

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2010. For the three months ended December 31, 2010, Alexion Pharmaceuticals, Inc. reported net product sales of Soliris® (eculizumab) of $156.0 million, reflecting strong additions of new patients, compared to $110.6 million for the same period in 2009.

10 Feb 2011

Idenix announces updates on HCV and HIV clinical development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

10 Feb 2011

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

Georgia Tech, Emory University startup receives $5.1M investment to develop novel cardiac surgery system

A Georgia Tech and Emory University medical device startup that has developed a system to simplify and standardize the technique for opening and closing the beating heart during cardiac surgery has received a $5.1 million investment.

10 Feb 2011

New study: Fetal surgery for spina bifida greatly improves child's mobility

Performing delicate surgery in the womb, months before birth, can substantially improve outcomes for children with a common, disabling birth defect of the spine. Experts at The Children's Hospital of Philadelphia co-led a new landmark study showing that fetal surgery for spina bifida greatly reduces the need to divert fluid from the brain, improves mobility and improves the chances that a child will be able to walk independently.

9 Feb 2011

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes.

9 Feb 2011

Repligen third quarter total revenue increases 26% to $7,068,000

Repligen Corporation today reported results for the third quarter of fiscal year 2011, ended December 31, 2010. Total revenue for the quarter was $7,068,000 compared to total revenue of $5,617,000 for the third quarter of fiscal year 2010 ended December 31, 2009, an increase of $1,451,000 or 26%.

9 Feb 2011

CeNeRx announces FDA approval of CXB909 IND for neuroprotection and neurodegenerative disorders

CeNeRx BioPharma, Inc., a clinical-stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced FDA approval of its IND and reported the first clinical results in humans for CXB909, a novel agent that has demonstrated utility in preclinical models of neuroprotection and neurodegenerative disorders.

9 Feb 2011

Elan and Boehringer Ingelheim enter global collaboration for antibody-based therapeutics

Elan plc and Boehringer Ingelheim today announced that they have entered into a global technical development and manufacturing agreement for antibody-based therapeutics.

9 Feb 2011

Vical announces issuance of US patent for HSV-2 vaccine

Vical Incorporated announced today the issuance of U.S. Patent No. 7,879,339, assigned to Vical and the University of Washington, covering DNA vaccines for herpes simplex virus type 2.

9 Feb 2011

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

Gentium S.p.A. today announced that ongoing preclinical and clinical studies on Defibrotide have been completed and confirmed its plan to file for regulatory approval of Defibrotide with the US Food and Drug Administration and the European Medicines Agency by the end of the second quarter of 2011.

9 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

9 Feb 2011

CytRx's bafetinib helps reduce skeletal complications in cancer patients

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies show that bafetinib may be useful in preventing bone loss in cancer patients who are at high risk for this event.

8 Feb 2011

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

Rib-X Pharmaceuticals, an antibiotics company with a broad development-stage pipeline, today announced the initiation of a Phase 2b clinical trial to evaluate delafloxacin, linezolid and vancomycin for the treatment of acute bacterial skin and skin structure infections, including infections caused by methicillin-resistant Staphylococcus aureus.

8 Feb 2011

Preclinical News and Research

Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Intellikine, PKD Foundation to investigate novel therapies for patients with PKD

Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Idenix announces updates on HCV and HIV clinical development programs

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

Georgia Tech, Emory University startup receives $5.1M investment to develop novel cardiac surgery system

New study: Fetal surgery for spina bifida greatly improves child's mobility

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Repligen third quarter total revenue increases 26% to $7,068,000

CeNeRx announces FDA approval of CXB909 IND for neuroprotection and neurodegenerative disorders

Elan and Boehringer Ingelheim enter global collaboration for antibody-based therapeutics

Vical announces issuance of US patent for HSV-2 vaccine

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

CytRx's bafetinib helps reduce skeletal complications in cancer patients

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

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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