Biogen and Food and Drug Administration

Selected news for the company - Biogen, and the healthcare topic - Food and Drug Administration. We have 995 shared news items for this connection to-date.

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Date Headline (link) Source Relevant Snippet
1/10/2022 A new Alzheimer's drug shows why the FDA's speedy approval process is broken Philly Tribune ... than wait for solid proof, especially if chances are you'll be dead by the time that proof comes around.The Food and Drug Administration's "accelerated approval" pathway is intended to address this challenge by allowing ... price tag that remains exceedingly high, even after its maker, Biogen, slashed the price in half, to $28,200 annually for the average patient.We think accelerated approval is a policy worth saving, but fixes are ...
12/22/2021 Eisai-Biogen Alzheimer's drug difficult to assess-Japan ministry | Nasdaq Nasdaq ... trial results made it difficult to determine the efficacy of an Alzheimer's treatment developed by Eisai Co 4523.T and Biogen Inc BIIB.O .Tokyo-based Eisai and its United States partner filed for Japanese regulatory ... doses of the drug could slow disease progression.The U.S. Food and Drug Administration (FDA) approved the drug earlier this year despite objections from an outside advisory panel its clinical benefit was unproven.Biogen said ...
12/16/2021 Biogen to start large trial to confirm Alzheimer's drug benefits - STAT STAT Pharmalot Pharmalittle: Biogen to start large trial to confirm Alzheimer‚Aos drug benefits; FDA to decide on easier access to abortion pill By Ed Silverman Dec. 16, 2021ReprintsAlex Hogan/STATT op of ... of its Alzheimer‚Aos treatment, pending clearance from the U.S. Food and Drug Administration, STAT writes. The trial, which was a condition of agency approval, could answer some outstanding questions that have kept many neurologists ...
11/28/2021 FDA OKs new Alzheimer's drug after 20 years. Experts disagree In a decision based as much on hope as on science, the Food and Drug Administration on Monday approved a drug designed to treat Alzheimer‚Aos disease despite scant evidence that it improved the symptoms ... the population ages.‚AuThe drug, to be marketed by Biogen Inc. under the brand name Aduhelm, reduces the amyloid beta plaques that build up in the brains of people with Alzheimer‚Aos. That ‚Auis ...
10/21/2021 'Major Bottleneck' Limits Alzheimer's Drug | Industrial Equipment News (IEN) The infused drug is hailed as a potential breakthrough treatment for a fatal disease. Oct 21st, 2021 The Biogen Inc., headquarters, Wednesday, March 11, 2020, in Cambridge, Mass. A new Alzheimer‚Aos drug from Biogen ... treatment from patients, CEO Michel Vounatsos said Wednesday.The U.S. Food and Drug Administration approved the drug, named Aduhelm, in June and later said it was appropriate for patients with mild symptoms or early-stage ...
10/20/2021 Lecanemab Follows Aduhelm's Path to Accelerated Approval Lecanemab Follows Aduhelm‚Aos Path to Accelerated Approval Quick Links 20 Oct 2021Part 1 of a two-part story.The Food and Drug Administration's approval of aducanumab based on plaque removal rather than clinical benefit has thrown open the gates for other anti-amyloid therapeutic antibodies to follow the same route to market. Eisai/Biogen are already on that path with lecanemab , having applied to the FDA for a ...
10/20/2021 Biogen CEO: ‘Major bottleneck’ still limits Alzheimer's drug SF Chronicle A new Alzheimer's drug from Biogen brought in only $300,000 in sales during its first full quarter on the market, continuing a slow debut complicated by coverage questions and concerns from doctors. The infused drug, hailed as a potential breakthrough treatment for a fatal disease, has encountered a health care system that "remains a major bottleneck" in keeping the treatment from patients, CEO Michel Vounatsos said Wednesday. The U.S. Food ...
10/19/2021 Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022 Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early ... to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package ...
10/19/2021 Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022 Business Wire CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct 19, 2021-- Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and ...
10/19/2021 Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022 ... Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half ...
10/19/2021 Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022 | Financial Buzz Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD ...
9/29/2021 Five things for health marketers to know: Wednesday, September 29, 2021 United Airlines may begin firing unvaccinated employees as early as this week, the company announced. In the wake of the company‚Aos mandate, 98.5% of employees have received the vaccine. ( CNBC Weekly )Biogen and Eisai will seek fast Food and Drug Administration approval for its experimental Alzheimer‚Aos therapy, lecanemab, the companies said Monday. The same pathway led to the approval of Aduhelm. ( STAT )Centers for Disease Control and Prevention ...
9/28/2021 Eisai, Biogen start U.S. accelerated approval for new Alzheimer's drug - NewsBreak CHICAGO, Sept 27 (Reuters) - Japanese drugmaker Eisai Co (4523.T) on Monday began its application process for its experimental drug for early Alzheimer's disease using an accelerated approval pathway, the same path that helped Eisai's development partner Biogen Inc (BIIB.O) win U.S. approval of its medication in June.The Biogen/Eisai drug Aduhelm was the first Alzheimer's treatment to win approval in nearly 20 years, but the Food and Drug ...
9/28/2021 REPORT: Biogen, Eisai Began Application For Alzheimer's Drug | The Daily Caller Biogen, and its Japanese partner Eisai, announced Monday that it plans to begin the process for U.S. approval for its experimental drug for Alzheimer‚Aos.Biogen and Eisai announced ‚Aurolling submission‚Au to the Food and Drug Administration (FDA) for its second Alzheimer‚Aos drug, lecanemab, according to a company press release. The companies expect the submission to be completed in the next several months.Biogen, Eisai seek fast approval ...
9/28/2021 Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway LECANEMAB IS AN ANTI-AMYLOID BETA (AŒ≤) PROTOFIBRIL ANTIBODY TOKYO and CAMBRIDGE, Mass, September 27, 2021 - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ‚AuEisai‚Au) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, ‚AuBiogen‚Au) today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company‚Aos investigational ...
9/28/2021 Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer‚Aos Disease Under the Accelerated Approval Pathway Published Date: September 28, 2021TOKYO, Sep 28, 2021 ‚Ai (JCN Newswire) ‚Ai Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401 ...
9/28/2021 Eisai Initiates Rolling Submission To The U.S. FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway TOKYO and CAMBRIDGE, Mass., Sept. 27, Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer's disease (early ...
9/27/2021 The road to Aduhelm: What one ex-FDA adviser called 'probably the worst drug approval decision in recent US history' for an Alzheimer's treatment By Jeffrey Toobin, CNN Dr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this ... would be marketed under the name Aduhelm by the company Biogen, which is based in Cambridge, Massachusetts. Aduhelm, if effective, would address one of the most pressing needs in modern medicine: to slow the symptoms ...
9/27/2021 The road to Aduhelm: What one ex-FDA adviser called 'probably the worst drug approval decision in recent US history' for an Alzheimer's treatment - Local News 8 By Jeffrey Toobin, CNNDr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this ... would be marketed under the name Aduhelm by the company Biogen, which is based in Cambridge, Massachusetts. Aduhelm, if effective, would address one of the most pressing needs in modern medicine: to slow the symptoms ...
9/23/2021 Premarket Movers Thursday - Darden, Salesforce, Biogen, BlackBerry - TheStreet TheStreet ... Biogen ( BIIB ) - Get Biogen Inc. Report edged higher after analysts from Needham gave the Cambridge, Mass., drugmaker a buy rating and said the market has not priced in the potential upside for its new drugs. The investment firm predicts a rally despite controversy around the company's Alzheimer‚Aos drug. In July, the head of the Food and Drug Administration called for an investigation into the approval of the ...
9/21/2021 Alzheimer's: the new scenarios in the fight against the disease ... Food and Drug Administration (FDA), in fact, he approved Aducanumab, a drug developed by the Pharmaceutical Company Biogen Inc. After decades of scientific research, this is the first treatment that specifically addresses the degenerative process of the disease and is not limited to just ‚Auattacking‚Au the symptoms of dementia. Aducanumab, in fact, seems to be able to slow down cognitive decline by acting directly on the two proteins ‚Ai ...
9/21/2021 The Cassava Saga: Here's What You Need To Know About This Embattled Alzheimer's Stock ... with mild-to-moderate Alzheimer‚Aos disease. If the effect continues for a year to 18 months, Cassava could follow Biogen ( BIIB ) with an approved Alzheimer‚Aos drug ‚Ai or not ... off Cassava‚Aos market cap. There is concern that the Food and Drug Administration might even halt Cassava‚Aos plans for Phase 3 testing. Sherman says it makes sense for investors in SAVA stock to ...
9/21/2021 SAVA Stock: The Ongoing Saga For The Most Volatile Name In Alzheimer's | Investor's Business Daily ... patients with mild-to-moderate Alzheimer's disease. If the effect continues for a year to 18 months, Cassava could follow Biogen ( BIIB ) with an approved Alzheimer's drug ‚Ai or not.Cassava's results were promising at ... billions off Cassava's market cap. There is concern that the Food and Drug Administration might even halt Cassava's plans for Phase 3 testing.IBD Newsletters Get exclusive IBD analysis and actionable news daily. SIGN UP ...
9/18/2021 Man among first to receive new Alzheimer's treatment ... clinic Friday as he became the first person to receive a dose of Aduhelm, the first drug approved by the Food and Drug Administration in nearly two decades to treat Alzheimer's disease.Zuendel is a ... make me extremely happy.‚AuIn June, the FDA approved Biogen‚Aos aducanumab , which they are now selling under the name Aduhelm, a drug that is administered by IV once every four weeks to slow ...
9/2/2021 Chairs Pallone and Maloney Request Answers from FDA on the Approval Process for Alzheimer's Drug Aduhelm US House of Representatives ... Food and Drug Administration (FDA) Acting Commissioner Dr. Janet Woodcock seeking information regarding the review process and accelerated approval of Biogen Inc.‚Aos Alzheimer‚Aos drug, Aduhelm. The letter to FDA follows a previous letter to Biogen in July and is part of the committees‚Ao ongoing investigation into the drug‚Aos approval process, marketing, and pricing.‚AuWe are concerned by apparent anomalies in FDA‚Aos processes surrounding its review ...