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The Lead

NIH Begins Early Human Clinical Trial of New Ebola Vaccine

October 22, 2014 2:00 pm | News | Comments

Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. Read more...                

UNC Researchers Found New Characters In Cancer Cells

October 22, 2014 1:47 pm | News | Comments

UNC School of Medicine researchers have pinpointed a set of intriguing characteristics in a...

Taiho Receives FDA Fast Track for Cancer Treatment

October 22, 2014 1:14 pm | News | Comments

Taiho Oncology Inc. announced that the FDA...

Oramed Gets Positive Data From Oral Insulin Trial

October 22, 2014 10:03 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage...

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Lilly's Diabetes Treatment Receives NDA

October 21, 2014 2:19 pm | News | Comments

FDA has accepted the filing of a NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Read more...       

Once CD8 T Cells Take on One Virus, They'll Fight Others Too

October 21, 2014 2:02 pm | News | Comments

Scientists think of CD8 T cells as long-lived cells that become tuned to fight just one pathogen, but a study finds that once CD8 T cells fight one pathogen, they also join the body's "innate" immune system, ready to answer the calls of the cytokine signals that are set off by a wide variety of infections. Read more...

RegeneRx Proceeds With Phase 3 Eye Drop Study

October 21, 2014 10:43 am | News | Comments

RegeneRx announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. Read more...

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Boehringer Ingelheim Initiates Phase 3 Cancer Study

October 21, 2014 10:34 am | News | Comments

Boehringer Ingelheim announced enrollment of the first patient in a new global Phase 3 study in patients with mCRC. Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Read more...

New Class of Drugs Shows Promise for Treating Chronic Diarrhea

October 21, 2014 10:23 am | News | Comments

A pilot study testing a new type of drug in patients with chronic diarrhea has shown promising effects on reducing their symptoms. Read more...                                    

BioPontis Alliance, HNF Partner to Develop Treatments for CMT

October 20, 2014 2:29 pm | News | Comments

BioPontis Alliance for Rare Disease and the Hereditary Neuropathy Foundation (HNF), both philanthropies, announced the creation of a joint venture to develop drug candidates for the treatment of the rare disease known as Charcot- Marie-Tooth (CMT) Disease. Read more... 

Taiho Receives FDA Fast Track Designation for Colorectal Cancer Drug

October 20, 2014 11:55 am | News | Comments

Taiho Oncology announced that the FDA granted Fast Track designation for TAS-102, an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the company has initiated a rolling NDA submission to the FDA. Read more...

Clanotech Receives Orphan Drug Designation in the EU

October 20, 2014 10:48 am | News | Comments

Clanotech AB announced that its anti-fibrotic and anti-angiogenic candidate drug CLT-28643 received orphan drug designation by the European Medicines Agency (EMA) for prevention of scarring post glaucoma filtration surgery.  Read more...

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Sanofi, Regeneron Announce Phase 3 Study of Atopic Dermatitis Drug

October 20, 2014 10:32 am | News | Comments

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications. Read more..

Drug Restores Pleasure-Seeking Ahead of Other Antidepressant Effects

October 20, 2014 10:14 am | News | Comments

A drug being studied as a fast-acting mood-lifter restored pleasure-seeking behavior independent of — and ahead of — its other antidepressant effects, in an NIH trial. Within 40 minutes after a single infusion of ketamine, treatment-resistant depressed bipolar disorder patients experienced a reversal of a key symptom — loss of interest in pleasurable activities — which lasted up to 14 days. Read more...

UCSF, CDRD Sign Drug Development Agreement

October 17, 2014 1:06 pm | News | Comments

UCSFo and CDRD, a non-profit drug development center headquartered in Vancouver, Canada, announced a collaborative affiliation to identify potential medications and develop them to the stage where they are commercially attractive to private sector partners. Read more...

Pharmacyclics' Non-Chemo Treatment Approved in Europe

October 17, 2014 10:54 am | News | Comments

Pharmacyclics Inc. announced that the European Commission (EC) has granted marketing approval for Imbruvica (ibrutinib) throughout the 28 member states of the European Union (EU). Imbruvica, a first-in-class, oral, once-daily, non-chemotherapy treatment, now is approved to be marketed in Europe. Read more...

Scientific Breakthrough May Help Design Future Antibiotics

October 17, 2014 10:33 am | News | Comments

Scientists have used computer simulations to show how bacteria are able to destroy antibiotics – a breakthrough which may help develop drugs which can effectively tackle infections in the future. Read more...

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A Novel Approach to Alzheimer’s Disease

October 17, 2014 9:57 am | by Daniel L. Alkon, M.D.,Chief Scientific Officer, Neurotrope Inc. and Toyota Chair in Neurodegenerative Disease, Scientific Director and Professor, Blanchette Rockefeller Neurosciences Institute | Articles | Comments

Alzheimer's disease (AD) afflicts more than 5 million people in the U.S. and 40 million worldwide, generating annual healthcare costs that exceed $200 billion in the U.S. and $600 billion globally. By 2050, AD is expected to strike more than 115 million patients per year, according to the Alzheimer’s Association. Read more...

FDA Fast Tracks Approval of Two ‘Historic’ IPF Drugs

October 16, 2014 4:22 pm | by Cynthia Fox, Science Editor | Articles | Comments

Two historic drugs for idiopathic pulmonary fibrosis (IPF) received “fast track, priority review, orphan product, and breakthrough designation” approval Wednesday from the Food and Drug Administration (FDA). Read more...

Big Step in Battling Bladder Cancer

October 16, 2014 3:06 pm | News | Comments

The millions of people worldwide who suffer from the painful bladder disease known as interstitial cystitis (IC) may soon have a better, long-term treatment option, thanks to a controlled-release, implantable device invented by MIT researchers. Read more...

Big Step in Battling Bladder Disease

October 16, 2014 1:33 pm | News | Comments

Novel device that stays in the bladder and slowly releases drugs sells to pharmaceutical giant. Read more...                                                             

Personalized Cellular Therapy Achieves Remission in Leukemia Patients

October 16, 2014 12:36 pm | News | Comments

Ninety percent of children and adults with ALL who had relapsed multiple times or failed to respond to standard therapies went into remission after receiving an investigational personalized cellular therapy, CTL019, developed at the Perelman School of Medicine at the University of Pennsylvania. Read more...

Roche, Cardiorentis AG Collaborate on AHF Drug Safety

October 16, 2014 10:41 am | News | Comments

Cardiorentis AG, a privately held biopharmaceutical company, announced a collaboration with Roche to establish the therapeutic efficacy and safety of Ularitide, the company's investigational drug for acute heart failure (AHF). Read more...

FDA Approves Boehringer Ingelheim's Drug for Lung Disease

October 16, 2014 10:30 am | News | Comments

 Boehringer Ingelheim announced that the FDA approved OFEV (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). Read more...

Eisai's Thyroid Cancer Drug Gets FDA Priority Review

October 15, 2014 10:45 am | News | Comments

Eisai Inc. announced that the FDA has accepted for review the NDA for its in-house developed agent lenvatinib mesylate as a treatment for progressive RAI-refractory DTC and granted the NDA Priority Review status. Read more...

Selecta, JDRF, Sanofi Collaborate on SVP Immunotherapy for Type 1

October 15, 2014 10:31 am | News | Comments

Selecta Biosciences and JDRF, announced that they have extended their joint research collaboration and attracted Sanofi as a partner in support of their program to develop an SVP immunotherapy with the long-term goal to treat and potentially prevent the underlying cause of type 1 diabetes. Read more...

Medtronic Begins Study of First Predictive Low Glucose Management Technology

October 14, 2014 1:39 pm | News | Comments

Medtronic Inc. announced that the first patients have been enrolled in an investigational device exemption (IDE) study of its breakthrough Predictive Low Glucose Management (PLGM) technology, marking a critical step toward development of an artificial pancreas in the U.S. market. Read more...

Rats of New York and The Diseases They Carry

October 14, 2014 12:29 pm | News | Comments

In the first study to look at would-be diseases carried by New York City rats, scientists at the Center for Infection and Immunity at Columbia University's Mailman School of Public Health identified bacterial pathogens, including E. coli, Salmonella, and C. difficile, that cause mild to life-threatening gastroenteritis in people. Read more...

Biologists Find Gene That Could Stop Tumors in Their Tracks

October 14, 2014 12:21 pm | News | Comments

The dirt in your backyard may hold the key to isolating cancerous tumors and to potential new treatments for a host of cancers. Read more...                                         

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