Spotlight Blog

New Chronic Lymphocytic Leukemia Cancer Drug

New Chronic Lymphocytic Leukemia Cancer Drug

FDA Approves Collaboration Drug After Extensive Clinical Trial Testing Recently, pharmaceutical research companies AbbVie and Genentech cleared the clinical trial requirements set by the FDA to approve of their new drug to fight against chronic lymphocytic leukemia. The result of these two companies’ collaboration was the production of a newly approved drug, Venclexta. This approval makes Venclexta the first FDA-approved drug in a new class that combats BCL-2, a protein responsible for rapid cancer cell growth. By blocking the cancer cell boosted growth, the pill allows for the cel...More

Psoriasis Drug Cleared by FDA

Psoriasis Drug Cleared by FDA

New Psoriasis Treatment Available After Successful Clinical Trials Psoriasis is a chronic immune disease that affects around 7.5 million Americans alone, with 1 in 5 suffering from moderate-to-severe plaque psoriasis. Eli Lilly’s ixekizumab recently won FDA approval as a new treatment therapy for psoriasis. Psoriasis Drug & the Clinical Research Trial Last year in April, the autoimmune treatment met its main goals in a Phase III clinical research trial. The way the drug works is that ixekizumab, an antibody, blocks the interleukin-17A cytokine and thus lessens the autoimmune-ca...More

Ovarian Cancer Drug Fast Tracked for Clinical Research Trial

Ovarian Cancer Drug Fast Tracked for Clinical Research Trial

Promising Results After Successful Patient Enrollment In Clinical Trial A new treatment for platinum-resistant ovarian cancer has been granted Fast Track status to the CA4P drug, developed by OXiGENE, Inc. Fast Track designation opens up wider access and communications with the FDA, and can later shorten the standard FDA review timeline from 10 to 6 months by allowing the drug to be submitted for priority review of the New Drug Application. CA4P (combretastatin-A4 phosphate or fosbretabulin) is a vascular disrupting agent (VDA) that targets existing tumor blood vessels. By quickly bi...More

Psoriasis Treatment Finishes PoC Clinical Trial Testing

Psoriasis Treatment Finishes PoC Clinical Trial Testing

Psoriasis Drug Will Undergo Further Research Trials To Test Effectiveness After completing a proof-of-concept (PoC) clinical trial, Vitae Pharmaceutical’s psoriasis drug proved to show its efficacy worth through the reduction of psoriasis severity. As a result, it will be designated the opportunity to undergo further clinical research trials. About The Psoriasis Drug The drug itself is referred to as VTP-43742. Unlike most psoriasis drugs in the market, VTP-43742 finds itself as an oral therapy in an otherwise injectable treatment-market, with Novartis’ Cosentyx leading the pack....More

Positive Clinical Trial Results Allow FDA To Approve New HIV Treatment

Positive Clinical Trial Results Allow FDA To Approve New HIV Treatment

Single Pill Combination Drug to Treat HIV Type-1 Gilead Sciences announced early this March that the U.S. Food and Drug Administration has approved Odefsey for treating HIV-1 infections. Odefsey, a single tablet, is a combination drug made up of emtricitabine, rilpivirine, and tenofovir aladfenamide (TAF). It has been approved to treat HIV type-1, the most common form of HIV. In November of last year, Genvoya, another Gilead drug treating HIV, was the first drug containing TAF to receive FDA approval. Odefsey, now the second FDA-approved TAF drug, is now the smallest single tablet r...More

Follicular Lymphoma Drug Approved by the FDA

Follicular Lymphoma Drug Approved by the FDA

Trial Results Show Significant Results Thereby Obtaining FDA Approval Genentech announced the FDA approval for their anti-CD20 agent drug, Gazyva (obinutuzumab), for follicular lymphoma patients who relapsed after, or are refractory to, a rituximab-containing regimen. This FDA approval was given after significant results were shown during the phase III clinical research trial for their Gazyva drug. Sandra Horning, MD, Genentech’s CMO and head of Global Product Development stated, “people with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxa...More

Positive Results from AML Clinical Research Trial – Midostaurin

Positive Results from AML Clinical Research Trial – Midostaurin

Trial Results Pave Way for Breakthrough Therapy Drug Designation Status Following the Phase III RATIFY clinical trial, Novartis received the Breakthrough Therapy drug designation for the acute myeloid leukemia drug, midostaurin. The Breakthrough Therapy drug designation allows for the expedition of drug development and review for medicines that treat serious or life-threatening conditions. The drug must have demonstrated quantitative improvement over a current available therapy on at least one clinically determined endpoint. In this case, the compound PKC412 (midostaurin) was compare...More

Janssen & Intrexon Collaborate Against Type 2 Diabetes

Janssen & Intrexon Collaborate Against Type 2 Diabetes

Using ActoBiotics to Further Clinical Research of T2D Intrexon Corporation and Janssen Pharmaceutica NV have entered into a research collaboration agreement in order to treat Type 2 diabetes (T2D). By discovering and further developing ActoBiotics® therapies, obesity and/or metabolic disorders related to dysregulation can also be targeted. Samuel Broder, M.D., SVP and Head of Intrexon’s Health said, “We believe this collaboration will make a significant contribution to this substantial global health issue. The breadth of opportunity to treat an array of diseases with our versati...More

Clinical Research Trial Shows Potential for MS Symptom Control

Clinical Research Trial Shows Potential for MS Symptom Control

Neurology Study Shows How to Prevent Nerve Damage Related to MS  Multiple sclerosis (MS) is sometimes indicated by the common symptom optic neuritis, in which the optic nerve carrying visual data from the eye to the brain becomes damaged due to inflammation. Dr. Raj Kapoor, of the Institute of Neurology at University College London, had his findings on optic neuritis published in The Lancet Neurology. The study found that phenytoin, an anti-seizure drug, protects against nerve damage in optic neuritis patients. Excess sodium in nerve cells causes an overproduction of calcium, which,...More

Recent FDA Approval Follows Melanoma Clinical Research Trial Results

Recent FDA Approval Follows Melanoma Clinical Research Trial Results

Opdivo & Yervoy Combination to Fight Advanced Melanoma Following Bristol-Myers Squibb’s CheckMate-067 phase 3 clinical research trial in patients with previously untreated advanced melanoma, the FDA has approved the combination Opdivo and Yervoy drug. Opdivo and Yervoy, BMS’s first melanoma immunotherapy, achieved an expanded combination approval in 2011 for just those with the negative BRAF mutation. Prior to this grant, patients with GRAF V600 wild-type mutation-positive unresectable or metastatic melanoma were not included in the target clinical audience. Now, patients wit...More