Thu.Oct 17, 2024

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STAT+: Medicare Advantage insurers ramped up use of technology to deny claims, Senate investigation shows

STAT

The nation’s three largest Medicare Advantage insurers increasingly refused to pay for rehabilitative care for seniors in the years after adopting sophisticated technologies to aid in their coverage decisions, a Senate investigation found. UnitedHealth Group, Humana, and CVS Health targeted denials among older adults who were requesting care in nursing homes, inpatient rehab hospitals, and long-term hospitals.

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Wave sees RNA editing validation in early trial results

PharmaVoice

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

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STAT+: How invisible medical groups are powering telehealth’s GLP-1 ‘gold rush’

STAT

In the last two years, telehealth has gone all in on GLP-1s. Dozens of companies have started to offer the wildly popular obesity and diabetes medications, meeting patients who are flooding online for prescriptions that could help them lose as much as 20% of their body weight.  The telehealth GLP-1 boom wouldn’t be possible without clinicians willing to write prescriptions for those hundreds of thousands of patients.

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As new Alzheimer’s biomarkers come into play, here’s where the money is going

PharmaVoice

The Alzheimer’s Drug Discovery Foundation has its finger on the pulse of diagnostics to add precision to the next wave of therapies.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Opinion: STAT+: Eli Lilly chief scientist Daniel M. Skovronsky: Beware elected leaders who would weaken patents

STAT

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. You can also read Sandoz CEO Richard Saynor on what the 2024 conversation is missing and Bayer Pharmaceuticals COO Sebastian Guth on bad policy ideas.

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After rejections, AbbVie secures approval for Parkinson’s drug

BioPharma Dive

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

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Sage to cut one-third of workforce, streamline drug pipeline

BioPharma Dive

The restructuring, which follows clinical setbacks in Alzheimer’s, Parkinson’s and tremor, will also involve the departure of five senior executives.

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STAT+: Alnylam’s CEO on welcoming competition, turning a profit, and a ‘spine-tingling moment’

STAT

For the last 20 years Alnylam Pharmaceuticals has converted Nobel-winning research on RNA-based gene-silencing into medicines, winning approvals for drugs delivered to the liver. That’s where some misfolded proteins are made, and in an increasingly diagnosed heart disease called ATTR cardiomyopathy, they eventually jam up muscles in the heart and contribute to heart failure.

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Researchers develop new method to deliver TB drugs directly to the brain

Express Pharma

Researchers have developed a new method to deliver Tuberculosis (TB) medicines directly to the brain, bypassing the blood-brain barrier (BBB), a protective barrier that limits the effectiveness of traditional treatments for brain TB. This method, designed to treat Central Nervous System Tuberculosis (CNS-TB), has the potential to significantly improve outcomes for this life-threatening condition.

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More evidence on GLP-1s and opioid addiction

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. I had the unexpected opportunity to wake up a little too early today, not unlike the way Bristol Myers Squibb CEO Chris Boerner had the unexpected opportunity to testify in front of Bernie Sanders earlier this year.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Sanofi, expanding in radiopharma, strikes a joint venture deal

BioPharma Dive

The French drugmaker will invest 300 million euros into a new entity that will develop lead isotope-based therapies for cancer under the Orano Med brand.

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STAT+: For this cancer-focused digital health startup, an FDA rejection meant the end of the road

STAT

The bad news didn’t come all at once for Blue Note Therapeutics, but a final denial from the Food and Drug Administration in January proved to be the final blow. In late 2023, after a rejection from the agency earlier in the year, Blue Note had made a last ditch attempt to convince the FDA that Attune, its mental health app for cancer patients, could fill an urgent unmet need.

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Union Commerce Minister Piyush Goyal holds meeting with pharmaceutical exporters to address industry concerns

Express Pharma

Union Commerce and Industry Minister Piyush Goyal recently convened a meeting with prominent stakeholders from the pharmaceutical industry to address the concerns of pharmaceutical exporters. The meeting, held on Wednesday, was attended by the General Secretary of the Indian Drug Manufacturers Association (IMDA), Mehul Shah, along with other key industry representatives.

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Opinion: STAT+: The biggest challenge facing the FDA’s new Rare Disease Innovation Hub

STAT

Over the summer, the Food and Drug Administration announced the creation of the Rare Disease Innovation Hub to serve as a point of collaboration and connectivity between the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), patient organizations, and product innovators with the goal of ultimately improving outcomes for patients.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Sage cuts a third of its workforce after R&D setbacks

pharmaphorum

Sage has launched another round of layoffs as it deals with the fallout of dropping a key pipeline drug for Alzheimer's and Parkinson's

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STAT+: Former UnitedHealth doctors detail what changed at their clinics after takeovers

STAT

For three physicians, the changes were gradual, and then unmistakable, when UnitedHealth Group took over their practices. They lost control over their schedules, they were told to prioritize coding their patients’ illnesses , they felt like widgets. Those were the experiences of three former UnitedHealth doctors  — Susan Baumgaertel, Michael Good, and Rubin Hirsch — who spoke at STAT’s annual summit in Boston on Wednesday.

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The Promise of a Direct-to-Patient Model—Breaking Down What’s Really Needed for Better Patient Access

Drug Channels

Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure, combined with clinical and reimbursement support specialists, can improve patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outco

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STAT+: Ballooning Medicaid costs challenge health insurer Elevance 

STAT

People who rely on Medicaid continue to get medical care at high rates, and it’s presenting a growing challenge for the major health insurers who cover them.  On Thursday, Elevance Health disclosed in its third quarter earnings release that its medical loss ratio — the amount of premium revenue it spent on medical care — was markedly higher than Wall Street analysts expected, sending its stock price into a tailspin.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Zydus gains final USFDA approval for Fludrocortisone Acetate Tablets USP, 0.1 mg

Express Pharma

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg (USRLD: Florinef Tablets, 0.1 mg). Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome.

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Biotech veteran Tony Coles on partisan politics and fulfilling a promise to his co-founder

STAT

Veteran biotech executive Tony Coles has been the man behind the curtain of two multibillion-dollar acquisitions and many more boardroom discussions.  But, publicly, he has arguably been just as active pushing the drug industry and other business leaders towards difficult conversations on corporate responsibility and race. Those conversations, he told the crowd at the STAT Summit in Boston Thursday, have been much more difficult.

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Investors and big pharma no longer avoiding techbio companies

Outsourcing Pharma

Investors and big pharma companies are waking up to the potential of techbio companies after years of avoidance, say experts at TechBio UK 2024, an event run by the BioIndustry Association (BIA).

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Biotech’s next gold rush, GLP-1 shortages, and STAT Summit highlights

STAT

Why are biotech investors so interested in autoimmune disease? Who is behind the telehealth GLP-1 boom? And what were our favorite moments from the STAT Summit this week? We talk about all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We chat about investors’ interest in using CAR-T to treat autoimmune conditions, the latest developments with the supply of Eli Lilly’s blockbuster weight loss drug, and the invisible m

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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NICE backs first targeted therapy for ALK+ lung cancer

pharmaphorum

NICE backs NHS use of Roche's Alecensa as first adjuvant therapy for ALK+ NSCLC, and peri-operative use of MSD's Keytruda for all-comer NSCLC patients

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STAT+: Consumer and labor groups urge FTC to block Catalent sale to Novo Holdings

STAT

A coalition of unions, consumer groups and public interest organizations urged the Federal Trade Commission to challenge a $16.5 billion deal in which Novo Nordisk’s parent foundation would acquire Catalent, a leading contract drug manufacturer, over concerns the acquisition will harm competition and reduce patient access to popular diabetes and weight loss medicines.

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First human skin atlas points way to healing without scars

pharmaphorum

The first human skin atlas is helping researchers to understand how skin forms, the mechanisms behind disorders, and could usher in scarless healing

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STAT+: A former Medicare official says the program is in trouble, and Medicare Advantage is largely to blame

STAT

Medicare is in trouble, and it’s largely the fault of the Medicare Advantage program that is run by private insurers, according to Donald Berwick, who ran Medicare during the Obama administration. More than half of people on Medicare are enrolled in private Medicare Advantage plans, and MA’s share of the market is growing fast. Medicare pays Medicare Advantage plans a set annual rate for each enrollee.

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Regulatory considerations for biosimilar analytical similarity assessments

Drug Patent Watch

Regulatory Considerations for Biosimilar Analytical Similarity Assessments Biosimilars, or follow-on biologics, are biopharmaceuticals that are highly similar to an already approved biological product.

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Amy Abernethy, former No. 2 at FDA, outlines new company’s plans to streamline clinical research

STAT

Former Verily executive Amy Abernethy outlined her plan to streamline clinical research on Thursday, revealing the first projects that her company, Highlander Health, will fund.  Abernethy, who previously served as the No. 2 official at the Food and Drug Administration, has spent a lot of time thinking about how to leverage data to improve our health, telling STAT in September that the idea for Highlander Health dates back to 2009.

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Vivan renews five-year lease at UK biotech hub White City Place

Pharma Times

The London hub is home to life sciences companies including Novartis, Engitix and invoX Pharma

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STAT+: Pharmalittle: We’re reading about doctors powering telehealth GLP-1 scripts, an FDA hold on a Novavax shot, and more

STAT

Top of the morning to you and a fine one it is. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the coffee kettle for yet another cup of stimulation. Our choice today is pecan pie with a dollop of honey added. Sweets for the sweet, you know. Meanwhile, we have assembled the latest menu of tidbits for you to peruse.

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Australia joins EU in turning down Alzheimer's drug Leqembi

pharmaphorum

Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.

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The GLP-1 telehealth boom, Senate investigation of MA plans, and the fall of a cancer startup

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. The medical groups propping up the GLP-1 telehealth boom It’s relatively simple to go online and get a prescription for a GLP-1 medication for diabetes or obesity thanks to dozens of companies that have stepped in to fill demand for the potentially life-changing treatm

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