Thu.Oct 17, 2024

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NCPA Addresses Independent Pharmacists’ Hesitancy to Stock Medicare-Negotiated Drugs

Drug Topics

The National Community Pharmacists Association surveyed over 4000 independent pharmacy owners and managers for their thoughts on the 10 drugs selected for Medicare price negotiations.

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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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Collaborative Care Approaches Can Improve Provider Shortage, Pharmacist-Physician Relationships | ACCP

Drug Topics

In posters presented at the American College of Clinical Pharmacy 2024 Annual Meeting, researchers explored the implementation of collaborative care programs within various health systems.

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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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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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As Meningococcal Disease Rates Rise, Researchers Evaluate Vaccine Efficacy | IDWeek 2024

Drug Topics

Cases of meningococcal disease currently exceed prepandemic levels.

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Emerging HER2-Targeted Therapies in NSCLC: Zongertinib and BAY 2927088

Pharmacy Times

HER2-mutant NSCLC is associated with poor prognosis. Zongertinib and BAY 2927088 are HER2 tyrosine kinase inhibitors that have activity in NSCLC with manageable toxicity profiles.

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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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3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev

Fierce Pharma

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.

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Nivolumab-Chemotherapy Combination Lengthens Survival, Causes Manageable Adverse Effects in Stage III or IV Classic Hodgkin Lymphoma

Pharmacy Times

Compared with brentuximab vedotin and chemotherapy, nivolumab and chemotherapy had longer progression-free survival and a better safety profile.

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Enhancing Medication Access, Addressing Health Disparities in Community Pharmacies | ACCP 2024

Drug Topics

Findings from a collection of posters at ACCP underscore the critical role of community pharmacies in promoting health equity and providing high-quality, patient-centered care.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Humanizing Pharmacy: Shifting From Volume to Value for Improved Care and Reduced Pharmacist Burnout

Pharmacy Times

Retail pharmacies benefit from the shift from a volume-centric model to a value-centric approach that focuses on enhancing patient care, reducing pharmacist burnout, and leveraging technology to improve efficiency and expand the scope of pharmacy services.

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Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

Fierce Pharma

As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto. | In a court decision filed in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld the green light that MSN won in July.

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Unmasking Health Care Fraud: RICO Is Increasingly Being Used in the Pharmaceutical Industry

Pharmacy Times

RICO is being leveraged in the pharmaceutical industry with significant implications for insurers and public trust.

Insurance 132
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Merck and Mestag Therapeutics Partner on Inflammatory Diseases in $1.9 Billion Collaboration

BioPharm

Through the collaboration, Merck will use Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

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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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A race-based test for kidney function is finally changing. What about the rest of medicine?

STAT

Jazmin Evans was waiting on dialysis for four years before finally, on the Fourth of July last year, she received a kidney transplant. “Now I say the fireworks are for me,” said Evans, who was diagnosed with kidney disease when she was 17.  She would have been waiting even longer had it not been for a shift, in 2021, in the way that physicians calculate kidney function for Black patients like her.

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FDA Approves Sodium Oxybate to Treat Cataplexy or EDS in Pediatric Patients With Narcolepsy

Pharmacy Times

Patients aged 7 years and older can now be treated for their cataplexy or excessive daytime sleepiness with the extended-release oral formulation.

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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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FDA Approves Foscarbidopa/Foslevodopa for Motor Fluctuations in Adults With Parkinson Disease

Pharmacy Times

This approval makes foscarbidopa/foslevodopa the first and only subcutaneous 24-hour infusion of levodopa-based therapy for adults with Parkinson disease.

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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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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+: 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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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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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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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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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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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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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+: 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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At Higher Risk, Vaccine Efficacy, Uptake Are Crucial for Older Adult Populations | IDWeek 2024

Drug Topics

Three RSV vaccines are currently FDA approved for use in adults aged 60 or older.

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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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Safe Travels Post-Transplant: Navigating Travel Risks and Appropriate Guidelines

Pharmacy Times

The guidelines emphasize the importance of vaccination, risk assessment, and preparedness for immunocompromised patients who are traveling post-transplant.

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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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Immunotherapy and Chemotherapy Combinations Show Promise for High-Risk HR+/HER2– Breast Cancer

Pharmacy Times

The KEYNOTE-756 and CheckMate 7FL trials show this combination improves pathological complete response rates in this patient population.