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Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

From Baxter International Inc. 11 Dec 2013

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

Avanir Pharmaceuticals, Inc. today announced that PRIME, its phase II clinical trial of the investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis did not meet the primary efficacy endpoint.

10 Dec 2013

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

A first-of-its-kind clinical trial studying two forms of stem cell treatments for children with cerebral palsy has begun at The University of Texas Health Science Center at Houston Medical School.

10 Dec 2013

Sanofi US launches second PiPH innovation challenge to improve drug development process

Today, Sanofi US launched its second Partners in Patient Health Innovation Challenge: Collaborate | Innovate, which will award $100,000 to the winning team. This year's theme is "Co-Creating for Breakthroughs: Moving toward a collaborative research and development ecosystem."

10 Dec 2013

electroCore’s non-invasive VNS therapy for headaches reviewed at AHS and NANS meetings

electroCore’s non invasive vagus nerve stimulation therapy for the prevention and treatment of cluster headache and migraine was reviewed at both the AHS Annual Scottsdale Headache Symposium (Nov 21st to 24th) and the NANS meeting this weekend (Dec 5th to 8th).

10 Dec 2013

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

For several years, epilepsy practitioners have questioned the U.S. Food and Drug Administration's definition of bioequivalence as it applies to narrow therapeutic index drugs, such as those used for epilepsy. In response to these concerns, the FDA has sponsored 3 studies of antiepileptic drugs and also convened an advisory board to help determine which drugs are NTI.

10 Dec 2013

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD), at the 55th Annual Meeting of the American Society of Hematology (ASH) held December 7 - 10, 2013 in New Orleans.

10 Dec 2013

European study investigates high blood pressure drug for treating Alzheimer's patients

An extensive European study is currently investigating whether a drug used to treat high blood pressure may also help patients with Alzheimer's disease. The EU is investing almost 6 million euros on the project, in which Sahlgrenska Academy and Sahlgrenska University Hospital are responsible for Sweden's contribution.

10 Dec 2013

Study offers new insight into benefits of vitamin D in people with multiple sclerosis

In mice with a rodent form of multiple sclerosis (MS), vitamin D appears to block damage-causing immune cells from migrating to the central nervous system, offering a potential explanation for why the so-called "sunshine vitamin" may prevent or ease symptoms of the neurodegenerative disease, according to results of a study at Johns Hopkins.

9 Dec 2013

CRAB CTC enrolls first patient into inaugural cancer clinical trial

Cancer Research And Biostatistics today announced enrollment of the first patient into the inaugural clinical trial sponsored by its Clinical Trials Consortium. The CRAB CTC mission is to ensure rapid clinical testing of new and innovative cancer treatments, and is focusing on lung cancer as its first target. By engaging frontline treating oncologists to push the boundaries of patient care, the aim is to improve the standard of care and extend overall survival.

9 Dec 2013

FDA advisory committee backs Takeda's vedolizumab for treatment of ulcerative colitis, Crohn's disease

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a joint panel of members from the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the United States Food and Drug Administration voted to recommend approval of Takeda's vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

9 Dec 2013

Increased inflammation in prostate may predict reduced risk for cancer

Doctors at the North Shore-LIJ Health System have discovered that increased inflammation in the prostate may predict reduced risk for prostate cancer. The findings are published online in CANCER.

9 Dec 2013

Adocia gets development and commercialization rights in nanotechnology for drug delivery

Adocia, a biotechnology company specializing in the development of ‘best-in-class’ medicines from already approved therapeutic proteins, announces today the signature of an exclusive license agreement with the CNRS, the University Bordeaux I, the Institut Polytechnique de Bordeaux and Aquitaine Science Transfert.

9 Dec 2013

Prana completes treatment phase of IMAGINE Alzheimer’s Disease clinical trial

Prana Biotechnology, a developer of best-in-class treatments for neurodegenerative disease, today announced the completion of the treatment phase of its IMAGINE Alzheimer’s Disease clinical trial.

9 Dec 2013

Studies confirm superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients

Findings from three large, randomized Phase III studies demonstrate the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patient populations, including newly diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec (as defined by 2013 European LeukemiaNet [ELN] guidelines).

9 Dec 2013

Children and adults with high-risk ALL benefit from novel, personalized cell therapy

Nearly 90 percent of children and adults with a highly aggressive form of acute lymphoblastic leukemia showed no evidence of cancer after receiving a novel, personalized cell therapy that reprograms a patient's immune system. In pilot studies of bioengineered T cells that attack leukemia, 24 of 27 patients (89%) experienced complete responses within 28 days after treatment. In all, 27 patients received the treatment--22 children treated at The Children's Hospital of Philadelphia and five adults treated at the Hospital of the University of Pennsylvania.

9 Dec 2013

Heptares starts HTL9936 Phase 1 study for improving cognitive function in Alzheimer's patients

Heptares Therapeutics, the leading GPCR structure-guided drug discovery and development company, announces that it has initiated a Phase 1 clinical study of HTL9936, the first fully selective muscarinic M1 receptor agonist to enter clinical development. HTL9936 is an orally available, small molecule drug candidate discovered using the Heptares GPCR structure-based drug design platform.

9 Dec 2013

UCSF awarded $9.45M federal grant to transform, revolutionize treatment of prostate cancer

UC San Francisco has been awarded a major federal grant to "transform and revolutionize" the treatment of prostate cancer, the second most common form of cancer among American men.

9 Dec 2013

Gene discovered to play a part in one per cent of all cancers

Researchers have identified a gene that drives the development of tumours in over one per cent of all cancer patients. This is the first time that the gene CUX1 has been broadly linked to cancer development.

9 Dec 2013

Clinical Trial News and Research

Navidea receives Fast Track designation for Lymphoseek injection

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

Sanofi US launches second PiPH innovation challenge to improve drug development process

electroCore’s non-invasive VNS therapy for headaches reviewed at AHS and NANS meetings

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

European study investigates high blood pressure drug for treating Alzheimer's patients

Study offers new insight into benefits of vitamin D in people with multiple sclerosis

CRAB CTC enrolls first patient into inaugural cancer clinical trial

FDA advisory committee backs Takeda's vedolizumab for treatment of ulcerative colitis, Crohn's disease

Increased inflammation in prostate may predict reduced risk for cancer

Adocia gets development and commercialization rights in nanotechnology for drug delivery

Prana completes treatment phase of IMAGINE Alzheimer’s Disease clinical trial

Studies confirm superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients

Children and adults with high-risk ALL benefit from novel, personalized cell therapy

Heptares starts HTL9936 Phase 1 study for improving cognitive function in Alzheimer's patients

UCSF awarded $9.45M federal grant to transform, revolutionize treatment of prostate cancer

Gene discovered to play a part in one per cent of all cancers

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