By Michelle Roberts Digital health editor Gut problems including constipation, difficulty swallowing and an irritable bowel may be an early warning sign of Parkinson’s disease in some people, a new study suggests. The findings in the journal Gut add more evidence to the idea that brain and bowel health are intimately linked. Understanding why gut issues happen might allow earlier treatment of Parkinson’s, say the researchers. Parkinson’s is progressive, meaning the brain disorder gets worse over time. What is Parkinson’s? People with Parkinson’s do not have enough of the chemical dopamine in their brain because some of the nerve cells that make it are damaged. This causes symptoms including involuntary tremor or shaking, slow, shuffling movements and stiff muscles. Although there is currently no cure, treatments are available to help reduce the main symptoms and maintain quality of life for as long as possible. Spotting the disease even sooner – ...
Dr. Heather Sandison, a leading expert in Alzheimer’s Disease and Related Dementia (ADRD) care, has recently published a groundbreaking study in the Journal of Alzheimer’s Disease, highlighting significant improvements in cognitive function among individuals with cognitive decline. The study is the second to employ a multimodal, individualized care plan and offers further hope for managing and potentially reversing cognitive impairment. The study, “Improved Cognition in People with Cognitive Decline: A Multimodal Intervention Approach,” is published in the Journal of Alzheimer’s Disease Volume (94) Issue (3) and focused on individuals with objective cognitive impairment (OCI), a precursor to Alzheimer’s disease. Dr. Sandison and her team recruited 34 participants from the San Diego, CA area to receive a comprehensive intervention based on potential contributors to cognitive decline, such as lifestyle changes, nutraceutical support, and medications. Over the course of six months, the participants underwent regular clinical visits and received ongoing nutrition support ...
While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug.Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. But PPD represents just a fraction of the total market Biogen and Sage were hoping to tap into. Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps. The dual approval and rejection was “more disappointing than good,” according to analysts ...
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 ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.