US FDA accepts Shire's lifitegrast NDA and granted priority review status

Shire plc announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date.

The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months

“Our NDA filing for

The NDA filing is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These include one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study.
lifitegrast represents an important regulatory milestone, exemplifying Shire’s ability to forge new paths in therapeutic areas aligned with our focus in rare and specialty conditions,” said Philip J. Vickers, Ph.D., head of research and development, Shire. “Our commitment to moving lifitegrast forward reflects our intent to grow in the Ophthalmics therapeutic category in areas of unmet patient need.  We look forward to working closely with the FDA throughout the review process.”

US FDA approves Konica Minolta's AeroDR XE wireless digital

Konica Minolta Medical Imaging, a world class provider and market leader in medical diagnostic primary imaging, has received the US Food and Drug Administration (FDA) clearance for its new AeroDR XE wireless digital radiography solution.

Healthcare providers in the demanding ER/Trauma rooms and ICU/CCU units need simple, reliable, and robust primary imaging solutions that deliver the information they need to make important patient care decisions quickly and confidently.

To address the needs of these fast-paced, extreme environments, Konica Minolta offers the simple yet powerful AeroDR XE, the lightest DR panel available today. Designed to provide unparalleled reliability and high-capacity imaging in extreme "on the go" environments the robust and highly durable AeroDR XE is also ideal for teaching hospitals, portable use and at the bedside.

Built to endure the rigors of extreme imaging environments outside the radiology department, the AeroDR XE combines the industry's most robust wireless DR panel with a simple yet powerful software interface.  As a result, users benefit from the best weight-to-load ratio – up to 661 lbs – and the highest bend and liquid resistance on the market. Weighing only 5.7 lbs, the AeroDR XE is the lightest panel on the market and easiest to handle.

Cell Cure seeks US FDA permission to begin phase I/IIa

HBL Hadasit Bio-Holdings Ltd., and Cell Cure Neurosciences Ltd. (Cell Cure) announced that Cell Cure has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking to initiate a phase I/IIa clinical trial of OpRegen in patients with geographic atrophy (GA), the advanced stage of the dry form of age-related macular degeneration (dry-AMD).

OpRegen consists of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of visual impairment.

The design of the proposed clinical trial, “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy,” is based on a pre-IND meeting with the FDA.. Patients will undergo a single transplantation and the study will explore three different doses of OpRegen. Following transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to moderate the disease progression.

US FDA grants fast track status to Pfizer’s clostridium

The US Food and Drug Administration (FDA) has granted Fast Track designation to the Pfizer’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhoea and pseudomembranous colitis.




“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio Emini, senior vice president of vaccine research and development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”

Clostridium difficile (klos-TRID-e-um dif-uh-SEEL), often called C. difficile, is the most frequent cause of healthcare-associated infections. C. difficile is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhoea (AAD) and accounts for 15-25 per cent of all episodes of AAD.
FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.

FDA approves first non-invasive DNA screening test for colorectal cancer

The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

Colorectal cancer primarily affects people age 50 and older, and among cancers that affect both men and women, it is the third most common cancer and the second leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention (CDC). Colorectal cancer screening is effective at reducing illness and death related to colon cancer. The CDC estimates that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided
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Colorectal cancer occurs in the colon (large intestine) or rectum (the passageway that connects the colon to the anus). Most colorectal cancers start as abnormal raised or flat tissue growths on the wall of the large intestine or rectum (polyps). Some very large polyps are called advanced adenomas and are more likely than smaller polyps to progress to cancer.

US FDA announces FY 2015 animal drug user fee rates for ADUFA & AGDUFA

The US Food and Drug Administration (FDA) announced in the Federal Register the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).

ADUFA, originally signed into law in 2003 and reauthorized in 2008 and 2013, amends the Federal Food, Drug, and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources support FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals that produce food for consumption. ADUFA III reauthorizes FDA to collect user fees through FY 2018.

FDA - Budget -2014

The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

The remainder of the budget increases would support programs which are necessary to preserve the safety of medical products and meet the agency's growing duties. Recognizing the need for fiscal constraint, the budget includes spending cuts in several areas, including a $15 million decrease in budget authority for human drug, biologics, and medical device programs.


"These are tight budget times, and the FDA budget request reflects this reality," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. "Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines approved as fast as or faster than anywhere in the world, confidence in the medical products they rely on daily, and a food supply that is among the safest in the world."

Chemist - Shops

the Mumbai chemists withdrew the agitation and shops are open without any time restrictions. But most of the chemist shops still do not have a pharmacist at the counter all the time. And the the FDA commissioner has not stopped his state wide inspection of chemist shops to see that pharmacists are present at the retail counter all the time.

Most of state governments in the country have miserably failed to ensure implementation of section 42 of the Pharmacy Act ever since the section was added to the Act. This section came into effect on September 1,1984 to end the practice of running  medical shops without qualified persons. The state pharmacy councils and drug control departments of Andhra Pradesh, Karnataka and Kerala had also conducted similar raids against retail chemists for violation of Section 42 in the past. But the practice continues even today and most of the 6 lakh retail chemist shops in the country are still being managed by salesmen with some superficial knowledge of medicines. Absence of a qualified pharmacist at the counter can definitely affect the quality of service by way of unprofessional counselling leading to wrong dispensing and over medication.

This needs to be strictly curbed in the interest of public health. Section 42 is an ideal piece of legislation and all the developed and most of the developing countries have the practice of keeping full time pharmacists at retail counters. In India, owners of chemist shops are blocking the implementation of the Section from the very beginning. Their objection to have a full time pharmacist at the counter is the 'unbearable' costs of appointing a pharmacist throughout the working hours in a chemist shop. That may or may not be true. But, when anyone venture into a business he cannot bypass the existing laws governing that business. And the enforcement agencies cannot be blind to perpetual violation of the provisions of any Act.


Therefore, both Centre and state governments have to seriously ponder about this lingering issue and have to come out with a right solution without any more delay.

FDA - Responsible for

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S Department of Agriculture)  are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective

• Protecting the public from electronic product radiation
• Assuring cosmetics and dietary supplements are safe and properly labeled
• Regulating tobacco products
• Advancing the public health by helping to speed product innovation.            

FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions