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FDA approves Hospira's meropenem for injection, USP (I.V.)

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration (FDA) approval for meropenem for injection, USP (I.V.) 500 mg and 1 g vials. The medication, a carbapenem that belongs to the beta-lactam class of antibiotics, is a generic version of AstraZeneca's Merrem® I.V. Sales of the name-brand product in the United States were approximately $200 million in 2009.

23 Jun 2010

Genentech's Lucentis for treatment of macular edema following RVO receives FDA approval

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review.

23 Jun 2010

PharmaTrust to introduce MedCentre remote pharmacy dispensing machine in UK

PharmaTrust will become the first company to introduce a remote pharmacy dispensing machine into the UK later this year. The Oakville, Ontario-based company announced yesterday at an event at Grocer's Hall in London that it is commencing trials of its MedCentre dispensing technology at five hospitals in the UK. Guests included government representatives, pharmacy stakeholders and media.

22 Jun 2010

Ricerca's Lyon facility obtains ISO 9001:2008 certification

Ricerca Biosciences, a uniquely integrated preclinical contract research drug development company providing services to the pharmaceutical industry, is pleased to announce that its Ricerca France, Lyon facility, has recently obtained the ISO 9001:2008 certification for all activities performed at the site.

22 Jun 2010

Three leading scientists gather to discuss Improved Strategies for Pre-clinical Cardiac Testing

Three leading scientists in the field of cardiac safety in pre-clinical drug development are gathering to discuss Improved Strategies for Pre-clinical Cardiac Testing in a free webinar on June 23 at 11:00 a.m. EDT, sponsored by the Drug Safety Council.

22 Jun 2010

Pro-Pharmaceuticals receives first purchase order for DAVANAT from PROCAPS

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has received its first purchase order for DAVANAT from PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia. Pro-Pharmaceuticals has received a purchase order for $200,000 which will be the upfront payment for this first shipment of DAVANAT.

22 Jun 2010

Data on Qnexa to be featured in six presentations at ADA annual meeting

VIVUS, Inc. today announced that data on Qnexa, an investigational drug candidate, will be featured in a total of six presentations – including an oral presentation, three moderated poster presentations and two poster presentations – during the 70th Scientific Sessions of the American Diabetes Association, being held from June 25-29, 2010 in Orlando, Florida.

22 Jun 2010

Biovest targets mantle cell lymphoma as next indication for BiovaxID

Biovest International, Inc. (Other OTC:BVTI) today announced at the Active Immunotherapeutics Forum in Barcelona, Spain, that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID. At the conference, the Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care.

22 Jun 2010

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the peer-reviewed journal Molecular Therapy has published a paper entitled "Comparative Analysis of Immune Responses Induced by Vaccination With SIV Antigens by Recombinant Ad5 Vector or Plasmid DNA in Rhesus Macaques." The paper, co-authored by researchers from Merck, University of Pennsylvania School of Medicine, and Inovio Pharmaceuticals, notes that significant advances in the design, formulation, and delivery of DNA plasmid-based vaccines have dramatically increased their ability to induce antigen-specific immune responses.

22 Jun 2010

Sun Pharma settles litigation with Orion over generic Stalevo, Comtan ANDAs

Sun Pharmaceutical Industries Ltd. announced that together with its affiliates ("Sun Pharma") it has executed a settlement agreement with Orion stipulating a dismissal of the lawsuits filed in the United States against Sun Pharma regarding submission of Abbreviated New Drug Applications (ANDAs) for generic versions of Stalevo® and Comtan® tablets.

22 Jun 2010

Dietary antioxidants improve insulin resistance in obese adults, study finds

A diet rich in natural antioxidants improves insulin sensitivity in insulin-resistant obese adults and enhances the effect of the insulin-sensitizing drug metformin, a preliminary study from Italy finds. The results will be presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

Esperion Therapeutics, a privately held biopharmaceutical company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that TransGenRx, a global leader in transgenic technology, will produce protein-based therapeutics to be used in the company's research efforts targeting HDL therapies for the treatment of cardio-metabolic disease.

22 Jun 2010

Omega-3 effective for treating depression in patients without anxiety disorders

The use of Omega-3 supplements is effective among patients with major depression who do not have anxiety disorders, according to a study directed by Dr. Fran-ois Lesp-rance of the Centre de recherche du Centre hospitalier at the Universit- de Montr-al (CRCHUM), head of CHUM's Department of Psychiatry and a professor at the Universit- de Montr-al. The study was published June 15 in the online Journal of Clinical Psychiatry.

22 Jun 2010

OMJPI, Diamyd Medical sign agreement to develop and commercialize GAD65 antigen-based therapy

Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced today it has signed an exclusive agreement with Diamyd Medical AB, a Swedish publicly traded company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications, to develop and commercialize their GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions.

22 Jun 2010

Gastric cancer drug market to grow from $700M in 2009 to $1.5B in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the rapid uptake and market penetration of key targeted agents, beginning with Roche/Genentech/Chugai's Herceptin, will drive the gastric cancer drug market to more than double, from $700 million in 2009 to nearly $1.5 billion in 2019.

22 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

BioSante Pharmaceuticals, Inc. commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD).

22 Jun 2010

Diamyd Medical, Ortho-McNeil-Janssen Pharmaceuticals sign agreement for diabetes therapy

Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.

22 Jun 2010

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company's topical formulation achieved target retina/choroid concentrations with minimal systemic exposure.

22 Jun 2010

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene-IV, which is marketed by Roche Laboratories, Inc.

22 Jun 2010

Pharmaceutical News

FDA approves Hospira's meropenem for injection, USP (I.V.)

Genentech's Lucentis for treatment of macular edema following RVO receives FDA approval

PharmaTrust to introduce MedCentre remote pharmacy dispensing machine in UK

Ricerca's Lyon facility obtains ISO 9001:2008 certification

Three leading scientists gather to discuss Improved Strategies for Pre-clinical Cardiac Testing

Pro-Pharmaceuticals receives first purchase order for DAVANAT from PROCAPS

Data on Qnexa to be featured in six presentations at ADA annual meeting

Biovest targets mantle cell lymphoma as next indication for BiovaxID

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Sun Pharma settles litigation with Orion over generic Stalevo, Comtan ANDAs

Dietary antioxidants improve insulin resistance in obese adults, study finds

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

Omega-3 effective for treating depression in patients without anxiety disorders

OMJPI, Diamyd Medical sign agreement to develop and commercialize GAD65 antigen-based therapy

Gastric cancer drug market to grow from $700M in 2009 to $1.5B in 2019

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

Diamyd Medical, Ortho-McNeil-Janssen Pharmaceuticals sign agreement for diabetes therapy

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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