Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

first_img– Advertisement – A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen‘s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company.In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s. Two other panelists said it the data was “uncertain.”The FDA could still approve the drug, which would make it the first drug approved to slow cognitive decline in people living with the disease and the first new treatment for Alzheimer’s in nearly 20 years.- Advertisement – Biogen headquarters on Binney Street on Thursday, March 21, 2019 in Cambridge, Massachusetts.Nicolaus Czarnecki | MediaNews Group | Getty Images Biogen’s intravenous drug targets a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease. Biogen has previously estimated about 1.5 million people with early Alzheimer’s in the U.S. could be candidates for the drug, according to Reuters.Some Alzheimer’s experts and Wall Street analysts have been skeptical about the drug’s benefits, especially after Biogen reversed its decision to seek regulatory approval in 2019.The company shocked investors in October of that year by announcing it was seeking regulatory approval after all after pulling the plug on the drug in March. Biogen scientists said at the time that a new analysis of a larger data set showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”There are currently no drugs cleared by the FDA that can slow or reverse the mental decline from Alzheimer’s, which is the sixth leading cause of death in the United States. The U.S. agency has approved Alzheimer’s drugs aimed at helping symptoms, not actually reversing or slowing the disease itself.During the meeting on Friday with the Peripheral and Central Nervous System Drugs Advisory Committee, Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said there was an “enormous unmet medical need.” “Currently approved treatments do not target the underlying pathology of Alzheimer’s disease and their beneficial effects are modest,” he said, adding there has not been an approval of a treatment for the disease since 2003.In a letter sent to the FDA ahead of the meeting, the Alzheimer’s Association said the publicly released data so far “justifies approval accompanied by a Phase 4 post-marketing surveillance study.”“The alternative, requiring completion of an additional Phase 3 trial, would deny broad access up to four years while it is completed. A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease. A four-year delay is too long to wait for millions of American caregivers,” the organization said.The FDA’s final decision on Biogen’s drug is expected by March.This is a developing story. Please check back for updates.center_img Shares of Biogen were halted Friday ahead of the meeting of outside experts.Biogen shares had surged Wednesday after FDA staff gave a positive review of the drug. In a 343-page document, the FDA said results from Biogen’s late-stage trial were “highly persuasive” and the study was “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness” of aducanumab. “Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval,” the FDA added.Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates more than 5 million Americans are living with the disease.- Advertisement – – Advertisement –last_img read more

Students work to balance internships and school

first_imgAs Internship Week ends, many students have worked to secure part-time positions to gain work experience and boost their resumes.Students must be careful, however, to maintain their GPAs if they add an internship to their schedule during the school year, according to Career Center Executive Director Carl Martellino.Studious · Uzair Chaudhury, a freshman majoring in business administration, hits the books. Maintaining a high GPA while interning requires managing time well. – Engie Salama | Daily Trojan“You need to have your grades high and you need to have your internships too,” Martellino said. “If students were letting their grades go in lieu of internships, then if they decide to go to grad school it will hurt them.”Maggie Burkhead, who received a bachelor’s degree in communication in 2011, said she had internships during the school year at a public relations company and at a television production company. She said taking classes while working made her feel pressured.“I remember being really stressed out about how I was going to do both,” Burkhead said. “My first internship was really demanding because I was doing things outside of work. I never changed my courseload, but I certainly got stressed out trying to manage my time in the most efficient way.”Burkhead said she wished she had received more advice on how to manage her time.“One class in particular definitely did suffer just because the work I needed to do for the class always coincided for things I needed to do for the internship,” Burkhead said. “My grade got bumped down a few points, mostly as a result of me not knowing how to manage my time better.”On the other hand, Mike Sullivan, a senior in public relations and cinematic arts critical studies, said his GPA improved when he had an internship at Variety last fall.“The internship sort of breathed some kind of vitality in my activities,” Sullivan said. “I was more driven to get things done. I don’t know if that specifically bled over into my schoolwork, but I was more driven during that semester.”Martellino said there are several ways for students with internships during the academic year to manage their time, including regular exercise and time management.“There is no simple answer,” he said. “We always recommend that students take some time for health, exercise and taking breaks. By trying to be strategic with work, student can make sure not everything piles up because that might be overwhelming.”He said students can group classes so one full day has no classes or do part of their internship online to lessen travel time for an off- campus internship.“I don’t think there is necessarily any easy answer,” Martellino said. “It becomes the way real life is going to be after graduation. Balancing commute, family, life and a full-time job is not unlike what the rest of real life looks like.”Diana Tay, a sophomore majoring in English and communication, takes classes only in the morning so she can go to her internships at Fox and ABC during the afternoon.“It’s easy to handle because I’m the type of person who likes to be busy all of the time,” Tay said. “Last year I planned my schedule in a way so I could do internships.”Tay said she hasn’t had trouble with time management.“I enjoy it because it keeps me busy,” Tay said. “If I didn’t have an internship, I would be sitting in my room watching TV anyway, so it’s kind of for my own benefit.”Martellino said having an internship while classes were in session could be a good thing because many internships relate to students’ majors.“Having [an internship] as a part of the course work is great [because] you can apply that to the real world and bounce it around with peers, and that has tremendous value,” Martellino said.Sullivan said his internship experience added to what he learned in school.“The experience I’ve had has been more valuable to me after what I’ve learned in school,” Sullivan said. “I learned by example what it is to be a good publicist or bad publicist by having to deal with good and bad publicists.”last_img read more