Thu.Dec 19, 2024

article thumbnail

FDA issues warnings to GLP-1 compounders

The Checkup by Singlecare

Originally approved to help people with Type 2 diabetes, the class of medications known as GLP-1 agonists and dual GIP/GLP-1s quickly acquired a reputation for helping people shed stubborn pounds. As a result, the use of medications like Ozempic , Wegovy , Zepbound , Rybelsus , and Mounjaro has skyrocketed, as people turned to these medications to help them lose weightcausing drug shortages and creating a market for compounded versions of these brand-name drugs.

article thumbnail

STAT+: Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions

STAT

CVS Health was accused of contributing to a nationwide epidemic of opioid addiction and overdose by filling illegal opioid prescriptions and billing federal health insurance programs, according to a lawsuit unsealed Wednesday by the U.S. Department of Justice. The lawsuit alleged that, since October 2013, CVS knowingly filled prescriptions for “dangerous and excessive quantities” of controlled substances that lacked a legitimate medical purpose, were not valid, and were not issued

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

What to know about Linzess and coffee

The Checkup by Singlecare

Tens of millions of people start their day with coffee without a second thoughtmany even find it difficult to have any thoughts at all before their first cup. But if youre taking prescription drugs on a regular basis, such as Linzess (the brand name for linaclotide), you may be wondering if you need to rethink your morning joe. Linzess is an oral medication that is approved by the Food and Drug Administration for the treatment of irritable bowel syndrome with constipation (IBS-C) as well as chro

article thumbnail

STAT+: Health plan formularies lowered barriers to fair access to some drugs, analysis finds

STAT

Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found. Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Adopting AI for R&D in 2025 – what needs to be addressed?

European Pharmaceutical Review

With the life sciences and healthcare sectors increasing integration of artificial intelligence (AI) into their infrastructure, according to research by GlobalData, one-third of healthcare professionals considered data privacy is the primary obstacle, citing challenges such as robust safeguards, workflow integration, and stakeholder acceptance [being] essential to ensure AIs ethical implementation and long-term success. 1 These concerns are held alongside the promise of this technology and its p

article thumbnail

STAT+: Pharmalittle: We’re reading about a Vertex pain drug, the Feds suing CVS over opioids, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and chilly breezes are wafting across the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is blueberry cobbler.

More Trending

article thumbnail

STAT+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The Food and Drug Administration on Thursday confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection. The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

article thumbnail

Telenutrition company Culina Health raises $7.9M series A

Fierce Healthcare

Culina Health, a telenutrition company, raised $7.9 million in a series A funding round led by Healthworx, the innovation and investment arm ofCareFirst BlueCross BlueShield, the co | Four year-old Culina Health has raised its series A funding round, led by Healthworx, the venture arm of CareFirst. The company seeks to normalize nutrition counseling and prove that a better diet lowers total cost of care.

article thumbnail

STAT+: House Republicans abandon PBM reform in push to keep government open

STAT

WASHINGTON — House Republicans have abandoned an effort to include reforms to pharmacy benefit managers in an end-of-year bill to fund the federal government. Congressional leaders had reached a deal to rein in prescription drug middlemen earlier this week, but the larger package it was tacked onto fell apart following backlash from conservatives and top advisers to President-elect Trump.

article thumbnail

Medical supply firm Medline confidentially files for potential blockbuster IPO in 2025

Fierce Healthcare

Medical equipment and supply manufacturer Medline Industries confidentially submitted plans for a proposed initial public offering, potentially setting the stage for a blockbuster public debut next | Medical equipment and supply manufacturer Medline Industries confidentially submitted plans for a proposed initial public offering, potentially setting the stage for a blockbuster public debut next year.

article thumbnail

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.

article thumbnail

STAT+: The health care deal is in jeopardy

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Elon Musk’s gift to PBMs? The year-end government funding bill was still in jeopardy as of the writing of this newsletter.

article thumbnail

NICE recommendation for KORSERDU®▼ (elacestrant) marks ‘step-change’ in the treatment of ESR1-mutated metastatic breast cancer

Pharmafile

19 December 2024 London, UK, Menarini Stemline UK today welcomed final draft guidance from the National Institute for Health and Care Excellence(NICE) recommending use of the first tailored treatment for locally advanced and metastatic breast cancer that has acquired mutations in the ESR1gene, estimated to benefit around 1,000 patients in England and Wales each […] The post NICE recommendation for KORSERDU(elacestrant) marks step-change in the treatment of ESR1-mutated metastatic breast c

article thumbnail

STAT+: Gilead plans to halt free access to an HIV drug, worrying patient advocates

STAT

Gilead Sciences will no longer provide four HIV medicines for free as part of a patient assistance program starting at the end of January, alarming community activists who worry the move will limit access and, consequently, impede nationwide efforts to combat the infectious disease. The list includes Truvada, a widely prescribed medicine that is used to treat and prevent HIV, but for which lower-cost generic versions are now available.

article thumbnail

DOJ Lawsuit Alleges CVS Helped Fuel Opioid Epidemic Through Unlawful Opioid Prescriptions

Drug Topics

The lawsuit alleges that the company knowingly violated both the Controlled Substances Act and the False Claims Act.

article thumbnail

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.

article thumbnail

Biotech stocks hammered after Fed rate projections

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. This is my last newsletter this year. Meghana will be writing the one tomorrow, and then we will be off for the next two weeks. Wishing everyone happy holidays and I’ll see you in the new year.

article thumbnail

Merck’s RSV antibody could soon paddle into the rough waters of a crowded market

PharmaVoice

A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.

article thumbnail

A deep dive on Makary, Vertex’s pain data, & 2025 predictions

STAT

Will a contrarian leader be good for the Food and Drug Administration? Which ATTR-CM drug will have the best launch? And what are the hosts making for their holiday dinners? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. STAT’s FDA reporter Lizzy Lawrence joins us to discuss her profile of Marty Makary, Trump’s nominee for FDA commissioner.

FDA
article thumbnail

Important Updates in RSV Vaccination Guidelines | ASHP Midyear

Drug Topics

A conversation with Chelsea Keedy, PharmD, BCACP, clinical assistant professor at the University of Georgia, on RSV vaccine recommendations.

article thumbnail

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.

article thumbnail

DOJ sues CVS, alleging it knowingly filled unlawful opioid prescriptions

Fierce Healthcare

The Justice Department has filed suit against CVS, alleging that the retail giant unlawfully dispensed opioid prescriptions. | The Justice Department has filed suit against CVS, alleging that the retail giant unlawfully dispensed opioid prescriptions.

article thumbnail

Education is Crucial to Prevent Hypoglycemia in Patients with Diabetes

Drug Topics

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, discusses key risk factors for hypoglycemia and what education programs should emphasize so people with diabetes and their caregivers can improve its management.

article thumbnail

How big pharma keeps affordable drugs out of reach – video

The Guardian - Pharmaceutical Industry

Pharmaceutical corporations claim high prices are the cost of innovation, but the reality is far more complicated and troubling. In 2030, the patents of some of the worlds best-selling drugs will expire, an event called the 'patent cliff', and companies are doubling down on tactics such as 'evergreening' patents and pay-for-delay deals to keep prices high and competition out.

article thumbnail

Opinion: AI’s dangerous mental-health blind spot

STAT

As we approach the end of 2024, First Opinion is publishing a series of essays on the state of AI in medicine and biopharma.  “ How far away was Oswald from Kennedy? ” “ Major depressive disorder.

article thumbnail

Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer

Fierce Pharma

Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. | Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S. The FDA nod comes four years after its initial approval in China.

FDA
article thumbnail

Why a healthy search strategy can power pharma brand growth

pharmaphorum

Discover how implementing a healthy and effective search strategy, focusing on Google, can significantly boost growth and success for pharmaceutical brands.

article thumbnail

MSD makes obesity play in up to $2bn deal for Hansoh’s GLP-1RA asset

Pharmaceutical Technology

MSD has entered an exclusive global licence agreement with Hansoh Pharma for a preclinical oral small molecule GLP-1RA.

article thumbnail

How small molecule-focused CDMOs can navigate the impact of the Inflation Reduction Act

pharmaphorum

Explore how small molecule-focused Contract Development and Manufacturing Organisations (CDMOs) are adapting to the impact of the Inflation Reduction Act (IRA), shifting legislative landscape, and changes in the investment landscape.

article thumbnail

FDA Recalls 233,000 Bottles of Duloxetine Over Risk of Cancerous Chemical

Pharmacy Times

Duloxetine is a commonly prescribed medication used to treat anxiety, depression, and other mental health disorders.

FDA
article thumbnail

Neuralink rival Precision raises $102m, and other financings

pharmaphorum

Neuralink rival Precision Neurosciences raises $102m for its brain-computer interface tech, plus financings for Redesign, DeepLife, TG0 and Tuva.

article thumbnail

Breaking Down Barriers to Care and Transforming Pharmacy Professionals’ Mental Health

Pharmacy Times

Pharmacy professionals deserve the right to pursue mental health care without fear of losing their jobs. The Wellbeing First Champion Challenge is helping change this.

article thumbnail

Ottimo raises $140m for its PD-1/VEGF cancer drug

pharmaphorum

Ottimo raises $140m for PD-1 and VEGF-targeting jankistomig, which the startup says is differentiated from bispecific antibodies in the class.

article thumbnail

Revisiting Artificial Intelligence as It Moves Rapidly Into the Mainstream (and Likely Your Workplace)

Pharmacy Times

Exponential growth in development is unsustainable in biological systems. But what about AI?

article thumbnail

Mesoblast finally pushes GvHD cell therapy over finish line

pharmaphorum

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

FDA
article thumbnail

FDA Approves Ensartinib for Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

Pharmacy Times

The indication is for patients with locally advanced or metastatic disease who have not previously received treatment with an ALK-inhibitor.

FDA