PharmaFocus Today – Page 355 – media

Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
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Amgen centers cancer patients’ voices in new YouTube series

Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
- Source: drugdu
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- June 4, 2023
Sandoz plans to stay local after Novartis separation, selecting new HQ in Basel

Paul Schloesser Associate Editor Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus. The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024. Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.” Sandoz did not immediately respond to queries from Endpoints News. Novartis announced back in August that it planned to spin out Sandoz as its own independent company, which is set to be listed on the SIX Swiss Exchange. Amid concerns ...
- Source: drugdu
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- June 4, 2023
Memory killer cells can improve survival for melanoma patients

Our skin contains specialized long-lived killer cells that protect against intruders. Researchers at Karolinska Institutet in Sweden have now identified how these cells are formed, and shown that high levels of memory killer cells in cancer tissue correlate with a better survival rate in people with melanoma. The study is published in the journal Immunity. Certain immune T cells called tissue-resident memory cells are formed locally in the skin and other tissue, and protect against infections that they have encountered before. Some of them express proteins that enable them to kill infected cells. These “memory killer cells” can also contribute to the inflammatory skin disorders vitiligo and psoriasis. Recent research has shown that they are also involved in the body’s immune response to various cancers. Varying responses to treatment The memory killer cells have been shown to respond to immunotherapy, a Nobel Prize-winning cancer therapy involving the tweaking/activation of the ...
- Source: drugdu
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- June 4, 2023
Children with drug-resistant epilepsy live longer after cranial surgery, large study finds

Survival rate beyond 10 years in children with drug-resistant epilepsy (DRE) was highest after cranial epilepsy surgery and lowest when treated only with antiseizure medications, according to a study published in The Lancet Child and Adolescent Health. This large, retrospective study was the first to compare long-term survival in children with DRE among cohorts treated with medications only, vagus nerve stimulation plus medications, and cranial epilepsy surgery plus medications. Results show that risk of early death was reduced by over 80% after surgery and by 40% after vagus nerve stimulation, compared to medication-only treatment. People with epilepsy have increased mortality rates compared to the age-matched population. Epilepsy is one of the most common neurological conditions, affecting at least 3.4 million people in the United States. Among children with epilepsy, an estimated 20% have DRE. “We provide critical evidence for healthcare decision making for pediatric patients with drug-resistant epilepsy,” said senior ...
- Source: drugdu
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- June 4, 2023
AZ, Merck’s Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
- Source: drugdu
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- June 3, 2023
eXmoor pharma raises $35m to boost cell and gene therapy production

eXmoor pharma has received an investment of around $35m in its Series A round to support the expansion of its cell and gene therapy production capability. The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners, respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as a result of the financing. The investment will allow eXmoor to launch its Cell and Gene Therapy Centre, a 65,000ft2 good manufacturing practice (GMP) facility. The purpose-built facility will help the firm to develop and produce autologous and allogeneic cell therapies in addition to viral vectors. It will see eXmoor leveraging around two decades of in-house facilities design, strategic cell and gene therapy (CGT) process development and transformation of its consultancy experience to become a comprehensive CGT contract development and manufacturing organisation (CDMO). Planned to be opened in Bristol, UK in this July, the facility will ...
- Source: drugdu
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- June 3, 2023
Lawmakers look to crack down on Big Pharma tax breaks

Drug pricing crackdowns aren’t the only way lawmakers are looking to reign in pharma’s business practices. With scrutiny of the industry intensifying on Capitol Hill, a Senate committee is now shining a spotlight on how Big Pharma is paying taxes, too. Earlier this month, Senate Finance Committee Chair Ron Wyden, D-Ore., released a memo revealing the latest findings of an ongoing investigation into how the industry has used a Trump-era law to reap massive decreases in tax rates. “Big Pharma gets us coming and going — they charge Americans sky-high prices and they pay absolute rock-bottom taxes,” Wyden said in a statement. According to Wyden, the industry has been leveraging a 2017 law that triggered a 40% reduction in the industry’s tax rate since it was enacted. All told, Wyden’s investigation found that in 2019 and 2020, the industry paid an effective tax rate of 11.6%, down from 19.6% on ...
- Source: drugdu
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- June 3, 2023
New links found between personality and cognitive abilities

In a new landmark study, University of Minnesota research shows surprising links between human cognition and personality—pillars of human individuality that shape who we are and how we interact with the world. Personality influences our actions, emotions and thoughts, defining whether we are extroverted, polite, persistent, curious or anxious. On the other hand, cognitive ability is the umbrella that reflects our capability for navigating complexity, such as articulating language, grasping intricate mathematics and drawing logical conclusions. Despite the prevailing belief that certain connections exist—for instance, introverted individuals are often perceived as more intelligent—scientists lacked a comprehensive understanding of these intricate connections. The research, published in the Proceedings of the National Academy of Sciences, synthesizes data from over 1,300 studies from the past century, representing more than 2 million participants from 50 countries and integrating data from academic journals, test manuals, military databases, previously unpublished datasets and even proprietary databases of ...
- Source: drugdu
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- June 3, 2023
Study shines light on cause of chronic kidney disease

Fresh insights into a protein that causes damage in kidneys and hearts could open up new treatment options for chronic kidney disease, research shows. In a study in mice, scientists found that scarring in kidneys and hearts was driven by a protein called Indian Hedgehog (IHH), which is produced and released by a subset of cells in aged and injured kidneys. Experts say further studies are needed to explore IHH as a potential target for therapies to treat chronic kidney disease (CKD)—a condition that affects 10 percent of the world’s population. CKD is a term used to cover any form of kidney disease that continues for more than a few months. It can affect people of any age, but older people are more likely to experience some level of CKD. While CKD primarily causes damage to kidneys, it is also a major risk factor for accelerated cardiovascular disease and premature ...
- Source: drugdu
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- June 3, 2023

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