Pharmaceuticals News and Research

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Pharmalink's Nefecon for IgA nephropathy receives FDA orphan drug designation

Pharmalink AB, a privately held Swedish pharmaceutical company, has received orphan drug designation by the US Food and Drug Administration (FDA) for its product candidate Nefecon (PL-56) for patients with IgA nephropathy, also referred to as Berger's Disease. This program is presently in clinical development phase II.

13 Oct 2010

Beta-Pro expands operations to meet increasing demand in $2 billion hepatocyte market

Beta-Pro LLC, announced today that it has expanded its operations to accommodate increasing demands from pharmaceutical drug discovery and research institutes in the $2 billion hepatocyte market. The human cellular sciences company now manages extensive laboratory facilities in the University of Virginia Research Park in Charlottesville, Virginia.

13 Oct 2010

USPTO grants HemoShear patent for human cell-based surrogate systems

HemoShear LLC, a biotechnology research company and leading developer of human cell-based surrogate systems for discovery and assessment of new drug compounds, today announced that the U.S. Patent and Trademark Office (USPTO) has granted it patent no. 7,811,782 entitled "Use of An In Vitro Hemodynamic Endothelial/Smooth Muscle Cell Co-Culture Model to Identify New Therapeutic Targets for Vascular Disease."

13 Oct 2010

Prosensa receives £7.5M milestone payment in GSK2402968 Phase IIa trial for DMD

Prosensa, the Dutch biopharmaceutical company focusing on RNA modulating therapeutics, has announced that it received a £7.5m milestone payment from GlaxoSmithKline (GSK) as a result of achieving a data milestone in its Phase IIa open label extension trial of GSK2402968 (PRO051), being developed to treat Duchenne Muscular Dystrophy (DMD) under its agreement with GSK. The milestone payment was based upon achievement of a successful safety review, with no serious safety signals observed.

13 Oct 2010

Imprime PGG and cetuximab increase overall response rate in metastatic colorectal cancer

A combination of Biothera's Imprime PGG and cetuximab (Erbitux) doubled the overall response rates for second- and third-line metastatic colorectal cancer patients participating in a Phase Ib/IIa clinical trial. The completed trial results were released yesterday at the 35th European Society for Medical Oncology (ESMO) Congress.

13 Oct 2010

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Threshold Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 1/2 clinical trial in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting being held in Milan, Italy.

13 Oct 2010

JAMA publishes Probuphine Phase 3 clinical trial data

Titan Pharmaceuticals, Inc. today announced that data from its previously completed and announced Phase 3 randomized, placebo-controlled clinical trial of Probuphine were published in the Journal of the American Medical Association (JAMA).

13 Oct 2010

New cancer initiative may promote rapid drug development

Greenville Hospital System University Medical Center (GHS) unveiled details of its new Institute for Translational Oncology Research, a visionary cancer initiative that will help pave the way for new breakthroughs in rapid drug development, diagnostic discovery and advanced cancer care. ITOR is part of the GHS Cancer Center, a recognized regional multi-disciplinary center.

13 Oct 2010

CyDex terminates joint development agreement on Captisol-enabled clopidogrel with Prism Pharmaceuticals

CyDex Pharmaceuticals, Inc. today announced a mutual decision with Prism Pharmaceuticals to terminate their existing joint development agreement on novel Captisol-enabled® intravenous formulations of clopidogrel. This provides CyDex with full development and commercialization rights to the product candidate - an injectable formulation of clopidogrel. Clopidogrel is the active ingredient in PLAVIX®, an orally available antiplatelet drug, which currently is marketed by Bristol-Myers Squibb Company and Sanofi-Aventis, Inc.

13 Oct 2010

CEL-SCI receives Taiwanese IRB approval for Multikine Phase III trial in head and neck cancer

CEL-SCI Corporation announced today it has received approval from the first Taiwanese Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare.

13 Oct 2010

Immunomedics receives additional patent claims for antibody therapy

Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that additional claims for the patent family "Method and kit for imaging and treating organs and tissue," were issued as U.S. Patent No. 7,811,570.

13 Oct 2010

Health care politics: Republican messages examined, how state propositions evolved

PolitiFact/St. Petersburg Times evaluated Republican claims in campaign ads about Medicare and the new health law that are "targeting older voters who may be worried their Medicare benefits will be harmed." Such ads are airing in Florida, Pennsylvania and California. "PolitiFact found each of those attacks to be Barely True. In these attacks and many others, PolitiFact found the ads have taken a small amount of truth — the Democratic incumbent's vote in favor of the health care law — and exaggerated the impact.

13 Oct 2010

B. Braun Medical announces availability of FDA-approved Cefepime in DUPLEX System

In an effort to meet industry demands for expanded Cephalosporin offerings delivered to patients through safe and accurate administration, B. Braun Medical Inc. (B. Braun) announced that FDA-approved 1g and 2g Cefepime for Injection USP and Dextrose Injection USP in B. Braun Medical Inc.'s DUPLEX Drug Delivery System will be available for purchase beginning today.

From B. Braun Melsungen AG 13 Oct 2010

CSL to distribute Cerus' INTERCEPT Blood System in Australia, New Zealand

Cerus Corporation announced today that it has entered into an agreement with CSL Limited, Biotherapies division to distribute Cerus' INTERCEPT Blood System for platelets in Australia and New Zealand. The INTERCEPT Blood System is designed to provide increased protection from a broad range of transfusion-transmitted pathogens, including bacteria and emerging pathogens such as the dengue and chikungunya viruses.

13 Oct 2010

Auxilium receives USPTO patent for XIAFLEX product

Auxilium Pharmaceuticals, Inc. a specialty biopharmaceutical company, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 7,811,560 claiming, among other things, purified collagenase, the active component in Auxilium's product XIAFLEX (collagenase clostridium histolyticum).

13 Oct 2010

Today's Opinions: Broken promises, Boehner's Plan B and implementing reform

My sister's cancer sent me into the medical literature with an insatiable hunger for information. It's this search for answers and 20 years of experience caring for women many of whom bore physical or emotional scars acquired in the aftermath of suspicious or inconclusive mammograms that led me to decide that I could no longer endorse the tests as routine screening measures for me or any other woman

13 Oct 2010

Smart for Life(R) to add Lepticore(R) to product line

Smart for Life(R), the trailblazing company featuring weight management products will begin adding Lepticore(R) to its product line this month.

12 Oct 2010

USPTO issues Watson Notice of Allowance for key progesterone patent to treat or prevent preterm birth

Columbia Laboratories, Inc. announced today that the U.S. Patent and Trademark Office (USPTO) has issued Watson Pharmaceuticals, Inc. a Notice of Allowance for a key patent for the use of progesterone to treat or prevent preterm birth. The USPTO issues a Notice of Allowance to report that a patent application has been examined and is allowed for issuance as a patent. The patent is expected to issue within three months upon payment of required fees.

12 Oct 2010

Boyden reports 35% increase in demand for Senior R & D Managers in Life Sciences sector

Fresh hiring decisions are being made at senior management levels, due to CEOs' bold moves to reshape businesses to the more permanent competitive reality, according to the quarterly Boyden Executive Outlook, released today by Boyden Global Executive Search.

12 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 2010

Pharmaceuticals News and Research

Pharmalink's Nefecon for IgA nephropathy receives FDA orphan drug designation

Beta-Pro expands operations to meet increasing demand in $2 billion hepatocyte market

USPTO grants HemoShear patent for human cell-based surrogate systems

Prosensa receives £7.5M milestone payment in GSK2402968 Phase IIa trial for DMD

Imprime PGG and cetuximab increase overall response rate in metastatic colorectal cancer

Threshold announces TH-302 Phase 1/2 clinical trial interim results

JAMA publishes Probuphine Phase 3 clinical trial data

New cancer initiative may promote rapid drug development

CyDex terminates joint development agreement on Captisol-enabled clopidogrel with Prism Pharmaceuticals

CEL-SCI receives Taiwanese IRB approval for Multikine Phase III trial in head and neck cancer

Immunomedics receives additional patent claims for antibody therapy

Health care politics: Republican messages examined, how state propositions evolved

B. Braun Medical announces availability of FDA-approved Cefepime in DUPLEX System

CSL to distribute Cerus' INTERCEPT Blood System in Australia, New Zealand

Auxilium receives USPTO patent for XIAFLEX product

Today's Opinions: Broken promises, Boehner's Plan B and implementing reform

Smart for Life(R) to add Lepticore(R) to product line

USPTO issues Watson Notice of Allowance for key progesterone patent to treat or prevent preterm birth

Boyden reports 35% increase in demand for Senior R & D Managers in Life Sciences sector

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

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