Biogen said its BLA for aducanumab, the Alzheimer’s disease candidate it is co-developing with Eisai, has been accepted for Priority Review by … Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.Discover announcements from companies in your industry. Alzheimer’s disease continues to confound scientists as failure after failure is taking its toll on investors in the space.

There might also be a push to drop programs deemed to be very risky or where the proof-of-concept requires long, expensive clinical trials.

Internally, the Pfizer reaction was intense. When discussing aducanumab, people often point to the regulatory experience with Duchenne muscular dystrophy.

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Biogen and Eisai’s drug candidate’s failure is a disappointment to the Alzheimer’s community aiming to find a treatment for the neurodegenerative condition, especially as fewer large companies work in the space after several high profile failures.

The FDA should “stop it in its tracks and require at least one additional study to confirm the benefit” of aducanumab before it’s approved.Biogen has said it does not expect to present additional data prior to the FDA’s decision, however, it is working on a study that will re-dose patients who were previously being studied. In effect, hundreds of millions of dollars needed to be cut from R&D. Biogen Inc. said an Alzheimer’s treatment it had left for dead earlier this year may work after all. The death of an important drug like aducanumab will have both a short and a long term effect on Biogen as a company and especially on R&D.I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, andI was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia.

Biogen finished 2019 as one of the worst performers in the S&P 500 Health Care Index, and some analysts have said the company may need an aggressive dealmaking strategy if the bet on Alzheimer’s doesn’t pay off.Biogen has been on the frontier of drug development for diseases attacking the brain and central nervous system and most recently The verdict may ultimately come down to politics. Whether that leads to any benefit has been a topic of heated debate among researchers.“I’d argue they failed to hit their internal criteria,” Baird analyst Brian Skorney said of Biogen’s studies. The drug company Biogen says it will seek federal approval for a …

Hedge funds including AQR Capital Management, Arrowstreet Capital and DE Shaw & Co. also have millions riding on the drugmaker’s success.Options set to expire on April 3 show an anticipated share price move of about 10% in either direction. • There was tremendous excitement generated in this potential breakthrough treatment, not just in Pfizer but also among cardiologists and heart patients. Oct 6 – Oct 7, 2020

Wonder whether Biogen’s resurrection of aducanumab has stoked unrealistic hopes for Alzheimer’s disease progress? in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. James Kupiec, CMO of the company, predicted that disease-modifying treatments could arrive on the market Copyright - Unless otherwise stated all contents of this web site are © 2020 - William Reed Business Media Ltd - All Rights Reserved - Full details for the use of materials on this site can be found in the

CONTINUE TO SITE ➞ It was a risky bet and one for which Wall Street has delivered a punishing blow. But upon further review, Biogen and partner “It all comes down to FDA’s willingness to approve a novel therapy with a debatable dataset in a disease that affects millions of patients,” said Guggenheim Securities analyst Yatin Suneja in a January phone interview. By signing up to receive our newsletter, you agree to our

While the data are “Once the agency starts a review, it could be anywhere from six to ten months before it reaches a decision whether to allow the drug on the market.

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