Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation Submitted To FDA For Approval

Johnson and Johnson Pharmaceuticals and Development LLC has filed a new drug application for  Rivaroxaban which is aiming to Prevent Stroke in Patients with Atrial Fibrillation.

RARITAN, N.J.--(BUSINESS WIRE)--Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

The submission is supported by data from the pivotal, global Phase 3 ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial.

AF is the most common sustained cardiac rhythm disorder, affecting more than 2.3 million people in the U.S. In patients with AF, the heart’s irregular beat makes them vulnerable to the formation of blood clots in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes can lead to major physical and behavioral impairments, or even death. People living with AF are at a five-fold increased risk for stroke compared with the general population, and almost one-third will suffer from a stroke in their lifetimes.

J&JPRD also announced today that it has submitted its complete response to the FDA seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The submission includes specific information requested by the FDA in a complete response letter issued to J&JPRD on May 28, 2009, and is primarily supported by data from the pivotal, global Phase 3 RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.

More information about the rivaroxaban clinical development program, and the diseases for which it is being developed, may be accessed at http://www.jnjpharmarnd.com/jnjpharmarnd/rivaroxaban.html.

About Rivaroxaban

Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. In clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions. The extensive program of clinical trials evaluating this compound makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which is part of the Johnson & Johnson Family of Companies, and Bayer HealthCare AG.

Treatment For Dry Age-Related Macular Degeneration Using Embryonic Stem Cells Cleared By FDA To Begin Phase I/II Clinical Trials.

Advanced Cell Technology, Inc. announced today the company’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) has been approved by FDA. Advanced Cell Technology, Inc now has permission  to begin a Phase I/II multicenter clinical trial to treat patients with Dry Age-Related Macular Degeneration. AMD is the most common form of macular degeneration, afflicting between 10-15 million Americans alone and currently no treatments available for this prevalent disease among the aging. As well as providing a medical solution for patients, economically treatment of Dry Age-Related Macular Degeneration, represents a substantial global market opportunity.

Following is the press release;

MARLBOROUGH, MA – January 3, 2011. Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). ACT is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90% of all cases. The progress of Dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient’s macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said Gary Rabin, Interim Chairman and CEO of ACT. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible. .”

The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.

“Dry AMD is the leading cause of blindness in individuals over the age of 55,” stated Robert Lanza, MD, ACT’s Chief Scientific Officer. “As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt’s Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt’s Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt’s Disease and Dry AMD patients.”

ACT’s Dry AMD therapeutic program uses RPE cells derived from hESCs to replace the lost RPE cells in the patient’s eyes. ACT’s proprietary RPE cell manufacturing process is protected by a number of broad patents, as is the use of hESC-derived RPE cells for treating macular degeneration. While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the Company hopes to demonstrate that the RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

“It is estimated that over ten million Europeans suffer from Age-Related Macular Degeneration, representing a vast unmet need and a significant market opportunity,” commented Edmund Mickunas, ACT’s Vice President of Regulatory Affairs. “We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe.”

Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives.

Recallr: FDA posts Warning Letter To vanderveercenter.com For False Or Misleading Claims Of Lipodissolve Products.

Recallr: FDA posts Warning Letter To vanderveercenter.com For False Or Misleading Claims Of Lipodissolve Products.

Absolute Humidity Governs Seasonal Flu Patterns In Winter!

With all the theories about why flu spread widely in winter, from weak immune systems to cooping up together in chilly weather, a scientific answer seem to be emerging.
It has been long known that the Flu Survival and Flu Transmission is related to humidity. It seems now that the lesser the humidity, absolute humidity, leading to lesser water vapors in the air, flu thrives. The relative humidity is a ever changing number which depends on the temperature has been an unreliable indicator for providing data for the study of flu.
National Institute of Health, NIH, supported disease modeling research team analyzed 30 years of flu and weather data and built a computer model that showed the patterns of how the seasonal flu spread.
Using absolute humidity, "we found that we could reproduce the seasonal cycle of influenza very nicely in basically the whole country. The flu virus survived longer and transmitted more easily from person to person in the low absolute humidity typical of U.S. winters. It didn't live as long and had more trouble transmitting in the high absolute humidity typical of summers " says Oregon State University climatologist Jeffrey Shaman one of the people who led the research team.
But just using humidifiers will not prevent people from getting flu, unless there is a humidifier large enough to humidify the whole continent, but then it might turn into a giant snow machine.
So the best prevention against flu is vaccination!

Novartis Invests $500 Million In Russian Pharmaceutical Manufacturing And Other Related Fields.

While a $500 million infusion to facebook has driven facebook to have a $50 Billion valuation, Novartis seem to be quietly approaching Russia with a similar amount of investment but the valuation has not jumped that much, if at all.

On the other hand Novartis investment is spread over five years and the first part of the investment project, Novartis has signed an agreement to build a pharmaceutical manufacturing facility in St. Petersburg, Russia. Other parts include infrastructure, health care initiatives, and R&D in Russia over the next five years. The  facility to be constructed this year will house technology for both generic and innovative pharmaceuticals. 

“This collaboration shows our commitment to contributing to the ambitious health care goals of the Russian government,” Novartis CEO Joseph Jimenez says.

Novartis says it will also invest in research collaborations  and may license Novartis compounds to qualifying Russian companies and license compounds from Russian scientists and universities which have developed compounds and solutions. Novartis aims to double its investment in drug development and clinical trials in Russia, joining Russian Prime Minister Vladimir Putin in pharmaceutical development in Russia. The Prime Minister pledged a $4 billion in federal funding for pharmaceutical industry development over the next 10 years. The Russian government wants 90% of Russia’s “essential medicines”, to be produced locally by 2020.

C&EN

PRock Marketing Recalls Fruta Planta Weight Loss Dietary Supplement.

FDA has published a warning and recall notice about PRock weight loss supplement formulas Fruta Planta and related products.
Recallr: PRock Marketing Recalls All Weight loss Formulas Reduce Weight Fruta Planta/Reduce Weight Dietary Supplement.

Happy and Healthy 2011 For All Of You!

Thank you everyone and I wish you all to be happy and and to be in excellent health. Finally this year the Meddesktop.com seem like coming alive, we will be focusing on Oncology (Cancer) related matters first as we expand the horizon with projects such as Oncowikia and OncoSemantic.
May all you be awesome this year.