By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
In reporting its first-quarter earnings, Biogen said it would halt the development of at least four investigational drugs to allow the company to focus on more lucrative opportunities.On Tuesday, Biogen revealed what those opportunities—and its other cost-cutting measures—would entail, saying (PDF) it would reduce its headcount by 1,000 by 2025. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce. At the start of 2022, Biogen employed (PDF) 9,610 people, according to an SEC filing. The numbers show that Biogen has already been working to downsize in the wake of the disastrous Aduhelm launch for Alzheimer’s disease. The latest measures will save Biogen $1 billion in operating expenses by 2025, the company estimates, with roughly $300 million of that earmarked for re-investment as Biogen launches key products, including newer Alzheimer’s disease drug Leqembi, which gained a full approval from the FDA earlier this month. Biogen’s shift comes ...
Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33 Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way. The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective. In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve ...
For the first time, Alzheimer’s patients in the U.S. have a treatment that has shown the ability to modify the disease in some patients. But experts have called Leqembi—developed by Eisai and Biogen—a “modest win” and a “first step” in the fight against Alzheimer’s disease. The next step could lie in untangling the correlation between amyloid and tau proteins—and defining what it means for drug development. The predominant theory is that Alzheimer’s is caused by the accumulation of two proteins—amyloid-beta and tau—in the brain. The anti-amyloid hypothesis received regulatory validation in June 2021 when the FDA approved Aduhelm (aducanemab) based on clinical data showing that the drug’s reduction of amyloid-beta plaques was reasonably likely to predict clinical benefit. A more solid endorsement arrived last week with the traditional approval of Leqembi (lecanemab). Leqembi and Aduhelm—along with and Eli Lilly‘s donanemab, which the company is expected to submit for regulatory approval soon—are anti-amyloid antibodies. All of these therapies have secondary ...
Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
Taking good care of your teeth may be linked to better brain health, according to a study published in the July 5, 2023, online issue of Neurology. The study found that gum disease and tooth loss were linked to brain shrinkage in the hippocampus, which plays a role in memory and Alzheimer’s disease. The study does not prove that gum disease or tooth loss causes Alzheimer’s disease; it only shows an association. “Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” said study author Satoshi Yamaguchi, Ph.D., DDS, of Tohoku University in Sendai, Japan. “Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason ...
Regular physical activity may protect against cognitive decline as we get older, but this protective effect may be diminished for people who are not getting enough sleep, according to a new study by UCL researchers. The study, published in The Lancet Healthy Longevity, looked at cognitive function over 10 years in 8,958 people aged 50 and over in England. The research team investigated how different combinations of sleep and physical activity habits might affect people’s cognitive function over time. They found that people who were more physically active but had short sleeps—less than six hours on average—had faster cognitive decline overall, meaning that after 10 years their cognitive function was equivalent to peers who did less physical activity. Lead author Dr. Mikaela Bloomberg (UCL Institute of Epidemiology & Health Care) said, “Our study suggests that getting sufficient sleep may be required for us to get the full cognitive benefits of ...
By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32. As part of the deal, Senator Investment Group’s Rohit Vanjani will join the AltPep board. Besides, Lilly’s senior vice president and chief scientific officer for Neurobiologicals Ronald DeMattos will become a member of the Scientific Advisory Board at AltPep. Vanjani noted: “We believe AltPep is in an excellent position to optimise the value of its unique technology. “With scientific application for both therapeutics and diagnostics in a wide range of amyloid diseases, the potential for the company’s pipeline is vast and extremely promising.” The ...
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