News

 

FDA GRANTS SMALL BUSINESS WAIVER TO CARMEL FOR CAR-501 NDA

 

ATLANTA, Georgia – 14 April 2016 Carmel Biosciences announced that the U.S. Food & Drug Administration has granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application (NDA) for CAR-501, their first human drug application. CAR-501 will be a new user-friendly liquid dosage form of a leading cardiovascular drug with “Gold Standard” clinical data.

"It’s great news for Carmel! We are obviously pleased with the FDA’s waiver approval of the PDUFA fee for CAR-501 NDA," Dr. Bobby Khan, Executive Director of Carmel Biosciences. “As a first-time new drug filer with the FDA we have the opportunity to receive an application fee waiver if we meet certain requirements, which we did, and the $2.4M savings will assist us in moving forward."

 

CARMEL BIOSCIENCES LAUNCHES MET-191, A NOVEL NUTRACEUTICAL PRODUCT

ATLANTA, Georgia – 02 December 2014 Carmel Biosciences announces the availability of Met-191 on its e-Commerce website. Met-191 is a product derived from berberine (an herbal product found primarily in China) and picrorhiza (a natural product found in Nepal and India).   Met-191 has shown benefits in liver health and lipid management.  ImproMet is an appetite suppression product involving cortithermogenic components.  In keeping with its absolute requirements for top quality, Carmel products demonstrate high levels of safety and are clinically tested to show its efficacy.  In 2015, Carmel plans the launch of two additional nutraceutical products for improved cardiovascular and metabolic health.

ANNOUNCEMENT OF ATLANTIC CANADA INNOVATION FUND AWARD TO THE UNIVERSITY OF PRINCE EDWARD ISLAND AND THE CARMEL BIOSCIENCES PARTNERSHIP

 

ATLANTA, Georgia – 19 June 2012 Carmel Biosciences announced today further successes in its partnership with scientists at the University of Prince Edward Island (UPEI).  The university has received an award for $3.77 million from the Atlantic Canada Innovation Fund (AIF) on the proposal titled “COMBINATORIAL DRUG DEVELOPMENT FOR INFLAMMATORY AND METABOLIC DISORDERS TO MAGNIFY HUMAN AND ANIMAL CLINICAL BENEFIT AND SAFETY”  Dr. Khan, Executive Director of Carmel Biosciences, and Dr. Tarek Saleh, Chairman of Biomedical Sciences at the University of Prince Edward Island, are the co-principal investigators of this proposal. This application aims to take a drug (CAR-208) that was developed at UPEI to clinical testing and development. This drug promises to bring new therapeutics to patients suffering from central nervous system diseases, including stroke, Parkinson’s disease and Multiple Sclerosis. Early testing has shown that this drug severely reduces the damaging effects of stroke in animals.

All AIF projects are approved following a rigorous and independent merit-review process by the AIF Advisory Board, composed of experts from across Atlantic Canada with knowledge of R&D, and business and economic policy.  The purpose of the AIF award is to support science and encourage innovation in Atlantic Canada. Researchers and entrepreneurs can use these funds to move their cutting-edge research and development from the lab to the marketplace. Additionally, this fund helps businesses and universities create and maintain research jobs and attract and retain world-leading research talent, which will lead to discoveries that improve productivity, competitiveness and overall quality of life.