Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen's stock rose 10%, but analysts had mixed opinions.
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 future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
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.
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.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
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.
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 […]
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
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 […]
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.