Mon.Sep 16, 2024

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Q&A: The U.S. can, and should, do more on H5N1 bird flu, a top WHO official says

STAT

More work needs to be done by the agricultural sector to get to the bottom of — and put a stop to — transmission of H5N1 bird flu in dairy cattle in the United States, a senior World Health Organization official said over the weekend. Maria Van Kerkhove, the WHO’s acting director of epidemic and pandemic preparedness and prevention, said the world is watching how the U.S., with its advanced scientific expertise, is responding to this outbreak.

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The DETECT V Trial: Exploring Chemotherapy-Free Treatment for HER2+/HR+ Metastatic Breast Cancer

Pharmacy Times

Data from the second interim analysis of the DETECT V trial, presented at ESMO Congress 2024, suggest that a chemotherapy-free regimen combining dual HER2-targeted therapy with endocrine therapy, particularly with the addition of ribociclib, may be an effective treatment for patients.

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Opinion: What the doctors’ protests in India are missing

STAT

In early August, a doctor was raped and murdered in a Kolkata public hospital by a “ civic volunteer ” who was neither a patient nor a staff member. The crime has enraged and rattled the medical profession in India. For weeks now, doctors have been protesting throughout the country, demanding among other things “justice for the victim” and a safer work environment.

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Q&A: Discussing Cebranopadol’s Potential in Pain Management

Drug Topics

Albert Dahan, MD, PhD, discusses recent data on Tris Pharma’s first-in-class dual-NMR agonist and how it will fit into the broader landscape of pain management therapies.

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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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Pediatricians’ obesity guidelines rest on shaky evidence about eating disorder risks

STAT

To address soaring rates of childhood obesity, the American Academy of Pediatrics last year endorsed tactics it once considered risky.  “Watchful waiting” had been standard practice, in part from concern that a doctor’s focus on weight could inadvertently plant the seed for stigma or eating disorders like anorexia and bulimia.

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Understanding Childhood Obesity: The 5 Most Common Interventions

Drug Topics

According to various research studies, these are the most commonly used interventions patients consider for treating and managing childhood obesity.

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More Trending

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What docs say is driving them away: 4 strategies to retain physicians

Fierce Healthcare

A large portion of physicians say they are toying with plans to leave their current position in the near future—a tough issue for healthcare organizations keenly aware of a practitioner shortage pr | About 35% of doctors said they are likely to walk out the door within the next five years, with about 60% saying they’re likely to leave clinical practice wholesale, according to a recent McKinsey survey.

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Opinion: End the ‘forced swim test’ on mice for antidepressant research

STAT

In 2022, more than 22 million Americans had serious thoughts of suicide or had made a plan to end their life. To treat depression, the leading cause of suicide death, there is an urgent need for novel antidepressants, as existing ones are only effective roughly 50% of the time. But there is a serious problem with the way we conduct research to improve depression treatment.

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NCQA released its annual health plan rankings. Here's how payers fared

Fierce Healthcare

The National Committee for Quality Assurance (NCQA) on Monday released its annual insurance rankings, with just five plans evaluated earning top marks. | The National Committee for Quality Assurance on Monday released its annual insurance rankings, with just five plans evaluated earning top marks.

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STAT+: After 10 years of game-changing immunotherapies, a cancer conference celebrates — and sees more work to do

STAT

BARCELONA, Spain — Ten years ago, a new type of cancer treatment reached the market. It worked by rousing the body’s own immune cells to attack tumors. Within months, regulators had approved two of the treatments, at first for melanoma.   The story — and the transformative impact — of Bristol Myers Squibb’s Opdivo and Merck’s Keytruda are well known at this point.

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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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KFF: Insurers set to rake in $11.8B in Medicare quality bonus payments for 2024

Fierce Healthcare

Health plans are set to rake in $11.8 billion in Medicare Advantage quality bonus payments, according to a new analysis from KFF.

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STAT+: Most cardiovascular devices with serious safety recalls aren’t tested in patients

STAT

When someone’s heart doesn’t beat quite right, an implantable defibrillator can save their life. The devices can jump-start a misbehaving heart, resetting its normal rhythm — unless they malfunction first. In 2022, Medtronic recalled more than 85,000 of the devices after dozens of complaints that a technical glitch could stop them from delivering the right, high-voltage shock.

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Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim

Fierce Pharma

Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat. | Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.

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STAT+: Pharmalittle: We’re reading about an AstraZeneca bladder cancer drug, Genentech anxiety, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation.

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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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Walgreens agrees to $107M whistleblower settlement over undispensed prescription allegations

Fierce Healthcare

Walgreens has agreed to a $106.8 million settlement over drug prescriptions that were billed to government programs but never dispensed, the Department of Justice announced Friday. | The government acknowledged Walgreens' cooperation in disclosing its improperly received payments and refunding $66 million, for which it received a credit toward the settlement amount.

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The essential biotech updates of the day

STAT

Morning! Today, we talk about bioethics, catch up on some reports from ESMO, and wonder aloud and in print over a surprising liquid biopsy bet. The need-to-know this morning Ascendis Pharma reported positive results from a Phase 3 study of  Transcon CNP in children with achondroplasia, the most common form of dwarfism. Children treated with the Ascendis drug grew an average of 1.49 centimeters in a year relative to a placebo, achieving the primary goal of the study.

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ESMO: NIAGARA backs Imfinzi in bladder cancer, but will FDA?

pharmaphorum

AstraZeneca reveals 'practice changing' data for Imfinzi as peri-operative therapy for bladder cancer, but will the FDA accept the study?

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FDA Approves Lebrikizumab-lbkz for Moderate-to-Severe Atopic Dermatitis

Drug Topics

Lebrikizumab-lbks is a targeted treatment that addresses the root cause of atopic dermatitis; by reducing inflammation throughout the body, it can help alleviate the dry, itchy, and irritated skin that often characterizes the condition.

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After the Lykos debacle, what’s next for psychedelic therapies?

Pharmaceutical Technology

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

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Examining the Impact of ePROMs in a Pharmacist-Led Telephone Clinic

Drug Topics

Patients who completed electronic patient-reported outcome measures said they made them feel more involved in their care and better supported.

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Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss

Fierce Pharma

Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. | Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss, or lebrikizumab, to treat atopic dermatitis.

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Cigna taps MDLIVE for new 'E-Treatment' virtual care offering

Fierce Healthcare

Cigna is rolling out a new "E-Treatment" program for its members in partnership with its MDLIVE unit. | Cigna is rolling out a new "E-Treatment" program for its members in partnership with its MDLIVE unit.

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AI-Optimized Cash Pricing Can Help Pharmacies Thrive

Drug Topics

Learn how one pharmacy chain adopted a cash pricing solution that offered new opportunities for profitability while still offering competitive pricing to customers.

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STAT+: What Medicare Advantage enrollment could look like for next year

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine.  Sign up  to get it in your inbox every Monday. What to make of the 2025 Medicare enrollment season In four weeks, Medicare beneficiaries will be able to sign up for 2025 coverage. And for the roughly 34 million people who are in a Medicare Advantage plan, things likely will look a lot different (and be as confusing as ever), my colleague Tara Bannow repor

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Support app for young cancer patients launches in UK

pharmaphorum

Rates of cancer among people aged 24 and below are rising fast, but health systems are often not catering well enough to the specific needs of this age group.A new partnership has been set up between the Ella Dawson Foundation, a UK-based charity for young people with cancer, and digital cancer care company Careology to try to tackle that deficit and improve their treatment and wellbeing.

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Vaxess' Rachel Sha - 'own the seat at the table that you have and have confidence'

Outsourcing Pharma

Rachel Sha has had a colorful career not without its challenges, but she urges women in the science industry to have confidence and answer hard questions.

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ESMO: Pfizer drug helps cancer patients gain weight

pharmaphorum

Pfizer's anti-GDF-15 antibody ponsegromab was able to achieve weight gain in cancer patients with cachexia in a phase 2 trial presented at ESMO

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Could new childhood obesity guidelines fuel eating disorders?

STAT

Good morning! For a limited time, you can get your first three months of a STAT+ subscription for just $5. It’s been about a decade since you could get a footlong from Subway at that price. So it’s a pretty good deal for all the latest news in health and the life sciences, if you ask me. AAP misconstrued research on childhood obesity and eating disorders For the first time in 15 years, the American Academy of Pediatrics last year put forward new clinical guidelines for addressing o

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AbbVie faulted for misleading ad featuring Serena Williams

pharmaphorum

FDA raps AbbVie for 'misleading' ad for migraine drug Ubrelvy featuring tennis star Serena Williams

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Take the 2024 Pharmacy Times Scope of Practice Survey

Pharmacy Times

With the end of the PREP Act provisions approaching, we want to understand how pharmacists feel about their scopes of practice in each state, and what they think about the future of the profession.

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FDA approves Roche’s Ocrevus Zunovo with Halozyme Enhanze delivery tech

Pharmaceutical Technology

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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The news from ESMO: An immunotherapy milestone, studying young-onset cancers, and more

STAT

This is the online edition of ESMO in 30 Seconds, a pop-up newsletter from the European Society for Medical Oncology’s annual meeting in Barcelona, Spain. There are no more editions this year, but you can keep up with biopharma news by signing up for STAT’s The Readout newsletter. A status check on immunotherapies It was 10 years ago that Keytruda and Opdivo were approved in their first indications.

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Pharmacists Play a Vital Role in Providing Care to Patients With Uterine Cancer

Pharmacy Times

Pharmacists’ role in community-based cancer centers are expanding, with a more significant role in treatment plan selection, education, collaboration to create individualized care plans, managing adverse effects, and aiding with financial toxicities.

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ESMO: Incyte's PD-1 treads new ground in anal cancer

pharmaphorum

Incyte's first attempt to get FDA approval for its PD-1 inhibitor Zynyz for squamous cell carcinoma of the anal canal (SCAC) was knocked back by the FDA, but new data could get the programme back on track.Zynyz (retifanlimab) is a late entrant to the PD-1/PD-L1 category but picked up its first approval in the rare tumour Merkel cell carcinoma last year.