Tue.Nov 05, 2024

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STAT+: Pharmacies sue GoodRx and PBMs over ‘illegal’ reimbursement fees

STAT

Three independent pharmacies have filed separate lawsuits accusing GoodRx, which markets a prescription drug discount card, of conspiring with several pharmacy benefit managers to fix reimbursement fees, the latest skirmish over the opaque pharmaceutical supply chain in the U.S. At issue are the behind-the-scenes transactions involving generic drugs, which account for an estimated 90% of the prescriptions written in the U.S. and, consequently, represent a lucrative market.

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CEO with type 1 diabetes works to deliver ‘world’s first’ functional cure

PharmaVoice

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

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Trending Sources

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Six GOP lawmakers poised for power on health care as the Senate flips Republican

STAT

WASHINGTON — With Republicans set to take control of the Senate in January, a new cast of lawmakers will gain power and influence on health care policy.  The GOP will have at least 51 seats in the chamber next year, after defeating the Democratic Sherrod Brown in Ohio and winning the West Virginia seat left open by Joe Manchin. Republicans also fended off challengers in states like Nebraska and Texas.

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Venus Remedies gains Malaysian PIC/S GMP approval for pre-filled syringe facility

Express Pharma

Venus Remedies has received Good Manufacturing Practices (GMP) approval with Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for its pre-filled syringe (PFS) facility at its Baddi unit. This marks the first PIC/S GMP accreditation for the PFS facility and adds to the GMPs already secured by the company from more than 25 regulatory authorities, including the WHO and European Union.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Screen time and autism, TikTok and birth control, fighting disinformation

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Election Day is finally here. What to say? If you’re feeling at all grateful for STAT’s journalism today, consider supporting our newsroom. We’re currently offering 40% off our annual subscription.

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AstraZeneca shares tumble after reports China unit is linked to insurance fraud

The Guardian - Pharmaceutical Industry

Pharmaceutical’s weight loss pill described as ‘underwhelming’, also piling pressure on share price AstraZeneca shares tumbled on Tuesday wiping £14bn off the value of Britain’s biggest drug maker, after a report that dozens of senior executives at its China unit could be implicated in an insurance fraud case in the country’s pharmaceutical sector. Also putting pressure on the share price, early data on AstraZeneca’s experimental weight loss pill published on Monday was described as “somewhat un

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Journey slips on FDA approval of rosacea therapy

pharmaphorum

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

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STAT+: Supreme Court justices appear split on case over $9 billion hospital payment program

STAT

Tuesday’s oral arguments before the Supreme Court in a case involving billions in Medicare payments to hospitals revealed a split among the justices willing to show their cards.  The case, Advocate Christ Medical Center v. Becerra, concerns Medicare payments to safety net hospitals, known as disproportionate share hospital, or DSH, payments, which are designed to compensate them for treating low-income patients.

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Novavax reaches settlement with UK Health Security Agency over COVID-19 vaccine agreement

Express Pharma

Novavax said on Tuesday that it has entered into a termination and settlement agreement with the UK Health Security Agency (UKHSA) related to its COVID-19 vaccine supply agreement. Under terms of the deal, the company and the UKHSA agreed to settle the outstanding amount under dispute related to upfront payments received by Novavax from the health agency.

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Strategies for effective biosimilar risk management plans

Drug Patent Watch

The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.

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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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Two former Alexion leaders fight through layoffs and a tough market to maintain a rare disease biotech

PharmaVoice

Rallybio is headed into a mid-stage trial with enough cash through 2026, but the cyclical market has made the journey difficult.

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Alvotech Requests that FDA Refuse to License CHO-Cell Derived Ustekinumab Biosimilars as Interchangeable Until the Effects of Sialylation Are Evaluated

Big Molecule Watch

Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe). Alvotech stated that “unless and until the Agency has evaluated and concluded that the differences in sialylation between the proposed interchangeable biosimilar and the reference product, STELARA (uste

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Encouraging data revealed for schizophrenia long-acting injectables

European Pharmaceutical Review

New data presented at Psych Congress 2024 has shown that the olanzapine long-acting injectable (LAI) TEV-‘749 / mdc-TJK demonstrated “significant improvement” in social functioning and quality of life in adults with schizophrenia. This was based on findings from the initial period (up to week 8) of the Phase III SOLARIS trial. According to Medincell, TEV-‘749 could be the first long-acting olanzapine medication with a favourable safety profile, because “other LAIs of olanzapine have been associa

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Cancer cell therapy from Arcellx, Gilead shows promise in early data

BioPharma Dive

The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.

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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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Beam points to positive data with key base editing asset

pharmaphorum

Beam shines a light on phase 1/2 data with its base editing candidate for sickle cell disease ahead of a full presentation at ASH next month

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Nitrosamine Mitigation: A Path to Regulatory Compliance

PharmaTech

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever. This ebook provides a comprehensive roadmap for understanding nitrosamine risks and offers actionable strategies to mitigate potential impurities. Through expert insights from Adare Pharma Solutions, you’ll learn how to remain compliant, identify risks, and implement cutting-edge strategies for nitrosamine

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Disc maps out US filing for porphyria drug bitopertin

pharmaphorum

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.

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How to Prep Your Pharmacy for Year-End Success in 2024

PioneerRx

Well, here we are: November, only two months until we welcome in the new year. As this year draws to a close, the last two months offer a powerful opportunity to.

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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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CRUK backs AI-powered, virtual radiotherapy trial projects

pharmaphorum

Cancer Research UK awards £5.

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Novo Nordisk signs $285m deal with Ascendis to create once-monthly GLP-1RA

Pharmaceutical Technology

Ascendis Pharma will license its TransCon technology to Novo to develop therapies for metabolic and cardiovascular diseases.

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Seeking a single source of truth: Standardisation of the data model

pharmaphorum

Learn the importance of having a standardised data model as your single source of truth in this insightful video interview. Gain valuable insights on data management and standardisation processes.

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Starget Pharma’s AI-Driven Cancer Therapy Gains $5.1 Million Backing

Outsourcing Pharma

Innovative radiotherapy offers a precision treatment alternative.

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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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Four key strategies for optimising your medical congress strategy

pharmaphorum

Learn about four key strategies for optimising your scientific medical congress strategy to maximise impact and engagement.

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Novo Nordisk’s semaglutide shows additional cardiovascular benefits in overweight patients

Outsourcing Pharma

Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.

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‘Historic’ legislation to ban smoking laid in Parliament

The Pharmacist

The government has today introduced ‘historic’ legislation to phase out smoking among young people, extend the smoking ban to outdoor spaces, and clamp down on vaping. The Tobacco and Vapes Bill, introduced in Parliament today, will ‘create a smokefree generation’ by banning the sale of tobacco products across the UK to anyone aged 15 or […] The post ‘Historic’ legislation to ban smoking laid in Parliament appeared first on The Pharmacist.

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Palomar Health inspires youth with hands-on medical program

Outsourcing Pharma

Palomar Health Foundation ignites youth interest in healthcare with Middle School Medical Discoveries program.

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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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An old drug with new tricks

World Pharma News

As the hunt for effective cancer therapies intensifies, some scientists are turning back to look at old drugs in a new light. The anti-malarial hydroxychloroquine is one such drug that has been "repurposed" to fight cancer. Despite its effectiveness at blocking the resupply of needed resources to cancer cells, clinical trial results have been disappointing, in part because cancer cells eventually become resistant to the drug.

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FDA grants accelerated approval to Novartis’ Scemblix as a first-line leukemia therapy

Outsourcing Pharma

Scemblix is the first drug to show superiority over all standard of care therapies for a rare type of leukemia.

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Global manufacturing capacity for active pharmaceutical ingredients remains concentrated

Quality Matters

Global manufacturing capacity for active pharmaceutical ingredients remains concentrated The globalization of the medicines supply chain has helped to increase access to quality medicines at a lower cost. At the same time, the supply chain has grown longer, more complex, and fragmented, leading to a lack of visibility and increase in the risk to its resilience.

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Sana to lay off staff, deepen autoimmune focus in latest retrenchment

BioPharma Dive

The company, which is only three years removed from one of biotech’s most lucrative IPOs, will cut jobs for a third time and invest more heavily in cell therapies for diabetes and lupus.

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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.