Thu.Dec 19, 2024

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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.

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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

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Trending Sources

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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

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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.

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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

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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.

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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.

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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.

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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

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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.

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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.

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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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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.

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FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

Fierce Pharma

The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. | The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. The agencys move means that compounding pharmacies will have to halt production of their knockoff versions of diabetes drug Mounjaro and obesity treatment Zepbound.

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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.

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Dupilumab Improves Moderate-to-Severe Atopic Dermatitis in Young Children With Inflammatory Comorbidities

Pharmacy Times

Proven effective in the treatment of atopic dermatitis (AD) and other allergic conditions, these study results confirm the ability of dupilumab to improve symptoms in children with other concurrent conditions.

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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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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.

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Public Health Matters Video: The Importance of Reproductive Justice and Black Maternal Health

Pharmacy Times

In this episode of Public Health Matters, Christina Madison discusses the concept of reproductive justice and ensuring Black maternal health efforts are not left behind with Regina Davis Moss of In Our Own Voice.

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Vertex weakens after neuropathic pain trial reads out

pharmaphorum

A trial of Vertex's suzetrigine in neuropathic back pain met its primary objective, but shares in the company fell as investors reacted to the data

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Remestemcel-L-rknd Receives FDA Approval for SR-aGvHD in Pediatric Patients

Pharmacy Times

The approval makes remestemcel-L-rknd the first approved mesenchymal stromal cell in the United States.

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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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Novartis sheds MorphoSys staff, sites after pelabresib delay

pharmaphorum

Novartis has confirmed it will shut down two MorphoSys sites in Germany and the US, with the loss of around 330 jobs, by the end of next year.

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NCPA: We’re on the Verge of Groundbreaking PBM Reforms

Pharmacy Times

But Congress must ignore big insurance and the PBM lobbys last-ditch effort to scuttle reforms and pass the continuing resolution

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Vertex’s stock hurt after non-opioid pain drug shows benefit similar to placebo

Pharmaceutical Technology

Vertex said the Phase II trial met its primary endpoint, however there was only a minor difference to placebo.

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Roche's Parkinson's hope fails second clinical trial

pharmaphorum

Roche and Prothena's alpha-synuclein-targeting prasinezumab for Parkinson's fails again, leaving them sifting through the data for efficacy signals

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FDA approves Mesoblast’s Ryoncil for SR-aGvHD treatment

Pharmaceutical Technology

Mesoblast has gained US FDA approval for its mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), to treat SR-aGvHD.

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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

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BioAge and Novartis seek drug targets for ageing-related diseases

Pharmaceutical Technology

BioAge Labs has entered a multi-year research partnership with Novartis to seek therapeutic drug targets for ageing-related conditions.

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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?

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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.

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Gilead recruits Terray in AI-driven drug discovery pact

Outsourcing Pharma

Gilead teams up with Terray for AI-powered drug discovery, leveraging Terrays tNova platform to accelerate the development of innovative treatments through generative AI and lab experiments.

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Novo Holdings completes Catalent acquisition for $16.5bn

Pharmaceutical Technology

Novo Holdings has completed the previously announced acquisition of Catalent in an all-cash transaction valued at around $16.5bn.

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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.

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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.

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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.

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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.

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