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Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Allos Therapeutics, Inc. today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company's Phase 3 clinical trial of FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).

4 Mar 2011

Palatin receives FDA clearance to begin PL-3994 Phase 2A trial for asthma treatment

Palatin Technologies, Inc. today announced that the U.S. Food and Drug Administration has cleared Palatin's request to begin a Phase 2A proof-of-concept human trial under an Investigational New Drug application using a subcutaneously administered formulation of PL-3994, an NPR-A agonist compound, in development for treatment of acute exacerbations of asthma.

4 Mar 2011

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

3 Mar 2011

CAS is an economically attractive alternative to endarterectomy for stroke patients

Researchers determined that carotid artery stenting with embolic protection is an economically attractive alternative to endarterectomy for patients at increased surgical risk.

3 Mar 2011

Honey for wound healing: Study

Researchers from the University of Queensland (UQ) and the Queensland Government have found honey from an Australian native myrtle to be effective as an anti-bacterial agent that can be used to treat wounds and viruses.

3 Mar 2011

Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

Endo Pharmaceuticals announced that FORTESTA Gel – recently approved by the U.S. Food and Drug Administration for the treatment of low testosterone, or 'Low T' in adult males – is now available by prescription in pharmacies across the country.

3 Mar 2011

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Eisai Inc. today announced that the U.S. Food and Drug Administration has approved BANZEL Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

3 Mar 2011

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.

3 Mar 2011

Clinton defends State Department budget requests before House panel

In her testimony before the House Foreign Affairs Committee on Tuesday about President Barack Obama's FY12 budget request, Secretary of State Hillary Rodham Clinton also defended the State Department's FY11 budget request, Bloomberg reports. Clinton said the proposed budget cuts for FY11 would be "devastating" to U.S. national security, and U.S. programs in Afghanistan, Pakistan and Iraq would see "sharp reductions" if the proposed cuts are passed.

3 Mar 2011

EU's Avastin policy: A stark contrast to the FDA's recent decision

The committee's decision stands in stark contrast to the recent verdict by the U.S. Food and Drug Administration, which is wary of Avastin's benefits for breast-cancer patients.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

Roche, OraSure receive FDA 510(k) clearance for Oral Fluid Drug Testing System

OraSure Technologies, Inc. and Roche announced today that the U.S. Food and Drug Administration has granted the Companies 510(k) clearance on four homogeneous fully automated oral fluid drugs of abuse assays developed to be used exclusively as part of OraSure's Intercept Oral Fluid Drug Testing System.

3 Mar 2011

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Eisai announced today that results from the global Phase III clinical study "EMBRACE" will be published online in The Lancet.

3 Mar 2011

Britain to cut foreign aid for 16 countries, focus more on family planning, safe water, maternal mortality

British Secretary of State for International Development Andrew Mitchell on Tuesday announced major changes to the nation's international aid program based on a nine-month review of the agency's policies, Reuters reports.

3 Mar 2011

FDA takes action against companies that manufacture unapproved prescription drugs

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

3 Mar 2011

Vical receives EMA Scientific Advice for Phase 3 trial of TransVax therapeutic CMV vaccine

Vical Incorporated announced today the receipt of Scientific Advice from the European Medicines Agency (EMA) recommending practical efficacy endpoints for a Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine.

3 Mar 2011

IBM announces new Patient Empowerment System

Today IBM announced the next evolution of the patient portal, significantly expanding the types of information, alerts, recommendations and interactive coaching healthcare providers can offer to their patients online.

3 Mar 2011

U-M scientists identify potential target to treat aggressive prostate cancer

Researchers at the University of Michigan Comprehensive Cancer Center have identified a potential target to treat an aggressive type of prostate cancer. The target, a gene called SPINK1, could be to prostate cancer what HER2 has become for breast cancer.

3 Mar 2011

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

EpiCept Corporation today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia patients in its previous Phase III trial with Ceplene administered with low-dose interleukin-2.

3 Mar 2011

Scientists devise new on-line calculator to predict food allergies in children

An on-line calculator that predicts, within seconds, the presence of the three major food allergies in children has been developed by researchers at University College Cork.

2 Mar 2011

Food News and Research

Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Palatin receives FDA clearance to begin PL-3994 Phase 2A trial for asthma treatment

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

CAS is an economically attractive alternative to endarterectomy for stroke patients

Honey for wound healing: Study

Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Clinton defends State Department budget requests before House panel

EU's Avastin policy: A stark contrast to the FDA's recent decision

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Roche, OraSure receive FDA 510(k) clearance for Oral Fluid Drug Testing System

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Britain to cut foreign aid for 16 countries, focus more on family planning, safe water, maternal mortality

FDA takes action against companies that manufacture unapproved prescription drugs

Vical receives EMA Scientific Advice for Phase 3 trial of TransVax therapeutic CMV vaccine

IBM announces new Patient Empowerment System

U-M scientists identify potential target to treat aggressive prostate cancer

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

Scientists devise new on-line calculator to predict food allergies in children

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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