The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug's clinical benefit.
The voluntary withdrawal was in response to an FDA request. Eisai said its interpretation of the data differed from the agency's, but the drug's original developer had called off pursuit of European approval when regulators there pointed to potential tumor risk from long-term use.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Drug regulators in the U.S., Canada and Australia simultaneously approved Merck's Keytruda and Eisai's Lenvima for advanced endometrial carcinoma following a collaborative review under a program called Project Orbis.
The move comes less than two months after the high-profile failure of aducanumab, which it had developed with Biogen, and the initiation a day later of a Phase III study of another amyloid beta-targeting drug, BAN 2401.
Biogen halting its Phase III trial of aducanumab last month had many proclaiming the amyloid beta hypothesis' demise. But many doctors soldier on, while others see potential alternative uses for Abeta-targeting drugs.
After Thursday's halt to aducanumab's development dealt a significant blow to the amyloid beta hypothesis in Alzheimer's, analysts had expected BAN 2401 - developed under a partnership with Biogen - to be shelved as well.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The news sent Biogen's shares down more than 26 percent pre-market, but analysts also wrote that it deals a significant blow to amyloid beta as a target in Alzheimer's disease.
The U.S. Food and Drug Administration’s move to approve the first obesity drug in 13 years seems to reflect a calculated risk by the regulator that the health hazards associated with weight loss drugs are eclipsed by the urgency of escalating medical costs associated with widespread obesity in the country. The healthcare costs associated with […]
Generic drug company Banner Pharmacaps has positioned itself to be first in line to market a generic version of Eisai skin cancer drug Targretin. The High Point, North Carolina company has filed with the Food and Drug Administration an abbreviated new drug application for Bexarotene 75 mg gelatin capsules. Targretin was approved to treat cutaneous […]
The patent wall protecting Eisai‘s (TYO:4523) blockbuster Alzheimer’s disease drug Aricept is crumbling fast with two more generics companies receiving U.S. Food and Drug Administration approval this week to take on the drug that Eisai manufactures at its Research Triangle Park, North Carolina facility. Teva Pharmaceutical Industries (NASDAQ:TEVA) and Actavis have both received FDA approval […]
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
Japanese drug company Eisai‘s (TYO:4523) bid to extend the patent life of its blockbuster Alzheimer’s drug Aricept with a new skin patch formulation has been dealt a blow by the U.S. Food and Drug Administration. Eisai’s drug partner Teikoku Pharma has received a complete response letter from the FDA stating that the agency cannot approve […]
Among today's current medical news, Eisai expects to cut about 900 jobs as the pharmaceutical company faces generic competition for Alzheimer's disease drug Aricept.
Eisai releases clinical trial results on two compounds and the drug development company will seek marketing approval on an epilepsy drug but withdraw such plans for a sepsis treatment after that drug fails in clinical trials.