Pharmaceuticals News and Research

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First Edition: June 7, 2012

Today's headlines include a report that some lawmakers on Capitol Hill are meeting to attempt to find ways to deal with an upcoming deadline -- Jan. 1 -- which is also known as the "fiscal cliff."

7 Jun 2012

$6.4 million awarded to investigate mechanisms of allergy tolerance generated by Circassia’s ToleroMune Treatment

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the United States’ National Institutes of Health (NIH) has awarded a $6.4 million grant to Professor Mark Larché of McMaster University, Canada, to study mechanisms of tolerance developed by patients treated with Circassia’s Toleromune® allergy therapy.

7 Jun 2012

Call for increased screening and faster testing for drug-resistant tuberculosis

Johns Hopkins experts in the prevention and treatment of multidrug-resistant tuberculosis are calling for increased screening and more rapid testing of the 9 million people worldwide estimated to be infected each year with TB, and now at risk for this form of the highly contagious lung disease. The call follows results of a survey showing that the harder-to-treat TB variants are much more widespread than previously thought.

7 Jun 2012

Studies evaluate transplantation potential and success of islet cells derived from pancreatic tissues

Two studies appearing in the current issue of Cell Transplantation, evaluate the transplantation potential and success of islet cells derived from pancreatic tissues, in addition to a clinical study that reports the occurrence of adverse events.

7 Jun 2012

Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease

Savient Pharmaceuticals, Inc. announced that new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA (pegloticase) regardless of baseline CKD stage.

7 Jun 2012

DODAC to discuss ThromboGenics’ new BLA for ocriplasmin intravitreal injection

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) has notified the Company that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for July 26, 2012.

7 Jun 2012

Debiopharm announces results from Debio 0932 Phase I study on cancer

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, presented results of a Phase I open-label dose-escalation study with Debio 0932, an oral Heat Shock Protein 90 (HSP90) inhibitor in clinical development as an anti-cancer agent.

7 Jun 2012

Boehringer Ingelheim updates U.S. prescribing information for Pradaxa with FDA

Boehringer Ingelheim has today announced that it has updated the US prescribing information for Pradaxa (dabigatran etexilate) in alignment with the US Food and Drug Administration (FDA) to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin."

7 Jun 2012

End-to-end regulatory solution for medical device companies in Europe offered by new partnership between ELC and mdi Europa

ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it has formed a preferred European partner relationship with mdi Europa GmbH, a global regulatory consultancy for medical device and IVD companies.

6 Jun 2012

Phase III study of AFOLIA, a biosimilar r-FSH meets its endpoint

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6 Jun 2012

AB Science announces data from development program of masitinib in GIST

AB Science SA, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), announces today that data from the development program of masitinib in gastrointestinal stromal tumors (GIST) have been presented as part of three presentations delivered at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting, 1-5 June in Chicago, Illinois.

6 Jun 2012

Arte, ProJect Pharmaceutics partner to develop Lyo-DCPS

Arte Corporation and ProJect Pharmaceutics have been working closely on the development of a new type of dual chamber prefillable syringe for freeze-dried pharmaceuticals. The two companies have joined together with the objective to provide innovative dual chamber syringes for the global pharmaceutical market.

6 Jun 2012

PhaseBio raises $48.4M in Series B financing

PhaseBio Pharmaceuticals, Inc., a privately held, clinical-stage biotechnology company developing drugs to treat diabetes, metabolic disease and cardiovascular disease, announced today that it has raised a total of $48.4 million from its Series B financing following receipt of the third tranche to advance the company's product development programs.

6 Jun 2012

BioLineRx receives two U.S. patent allowances for BL-1021 to treat neuropathic pain

BioLineRx, a biopharmaceutical development company, announced today that two Notices of Allowance have been issued by the United States Patent and Trademark Office (USPTO) for BL-1021, an orally available small molecule for treating neuropathic pain.

6 Jun 2012

VGXI, OncoSec partner to produce interleukin-12 plasmid DNA

OncoSec Medical Inc., which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announced today that the Company has entered into an exclusive cGMP manufacturing agreement with VGXI Inc. (VGXI) for the production of interleukin-12 plasmid DNA.

6 Jun 2012

Bayer announces updated data from radium-223 dichloride Phase III trial on CRPC

Bayer HealthCare today announced updated data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial for its investigational drug radium-223 dichloride in men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.

6 Jun 2012

inVentiv Health acquires Kazaam Interactive

inVentiv Health, Inc., offering best-in-class clinical, commercial and consulting services to the healthcare industry, today announced that it has acquired Kazaam Interactive, a full-service interactive agency providing comprehensive solutions and services for healthcare agencies and brands.

6 Jun 2012