Mon.Sep 23, 2024

article thumbnail

STAT+: Electronic health records giant Epic Systems sued over alleged monopolistic practices

STAT

The health data company Particle Health has filed an antitrust lawsuit against Epic Systems, alleging that the electronic health record vendor has used its control of patient data to thwart competition and undermine its business. The suit filed Monday in federal court in the Southern District of New York is a full-throated assault on Epic’s dominance in the market for electronic health records, charging that the privately held company has become a “behemoth” and a “mo

363
363
article thumbnail

What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

LifeProNow

Decentralized clinical trials (DCTs) are an innovative approach to conducting clinical research, where some or all trial-related activities occur at locations other than traditional clinical trial sites. These locations can include participants’ homes, local healthcare facilities, or nearby laboratories. Key Features of DCTs: Remote Participation: Participants can engage in the trial from their homes or local clinics, reducing the need for travel.

Diabetes 130
Insiders

Sign Up for our Newsletter

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

article thumbnail

STAT+: A mysterious anti ‘Big Pharma’ bus is barnstorming swing states

STAT

WASHINGTON — The wheels on a big red bus emblazoned with anti-pharmaceutical industry messaging are going ’round and ’round all through the nation’s electoral battlegrounds, from Montana to Arizona to Pennsylvania. But nobody will say who’s paying to fill up the gas tank. A new dark-money group called Americans for Pharma Reform has launched a multi-state bus tour to bring awareness to what they characterize as bad behavior by the pharmaceutical industry.

article thumbnail

Patient access: How Novartis, Eli Lilly, and other Big Pharmas measure up

PharmaVoice

A new report examines the patient reach efforts of 20 of the world’s largest pharma companies in low- and middle-income countries.

130
130
article thumbnail

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.

article thumbnail

STAT+: Millions of Americans want to quit smoking. Critics say drugmakers and the FDA are failing them

STAT

WASHINGTON — Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year. The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them.

Vaccines 359
article thumbnail

Biogen, UCB get the lupus data they’ve waited two decades for

BioPharma Dive

The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.

120
120

More Trending

article thumbnail

CCA calls for pharmacy diabetes screening service

The Pharmacist

The Company Chemists' Association (CCA) has called on the government and the NHS to commission a national diabetes screening service from within community pharmacies. This should be underpinned by 'seamless IT referral pathways' and patient pathways allowing independent prescribing pharmacists to initiate treatment where needed, the trade body, which represents large multiple pharmacies, said.

Diabetes 112
article thumbnail

STAT+: As Medicare spending on remote patient monitoring jumps, HHS watchdog warns of fraud, misuse

STAT

The federal watchdog at the Department of Health and Human Services issued a report on Tuesday calling for more oversight of remote patient monitoring in Medicare. The Office of Inspector General’s report called out the potential for fraud and misuse of tools like at-home blood pressure cuffs, connected scales, and continuous glucose monitors that can feed data directly to a patient’s doctor.

348
348
article thumbnail

After setback, Biohaven to seek approval of neurological disorder drug

BioPharma Dive

With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.

120
120
article thumbnail

Opinion: New HHS rules can’t address the primary reason for research misconduct

STAT

On Tuesday, the Department of Health and Human Services published new policies  on research misconduct , which apply to research institutions receiving funding through the U.S. Public Health Service. The policies set standards that institutions must follow when investigating and potentially sanctioning researchers alleged to have engaged in research misconduct.

334
334
article thumbnail

Grow Big, Pay Smart: How To Unlock Efficiency In Payroll Management

Speaker: Joe Sharpe and James Carlson

Running a small business is no small feat. Payroll management, in particular, can be one of the most time-consuming and complex parts of that equation. Yet, businesses that crack the code on streamlining these processes often discover not just savings, but new avenues for growth. Our expert speakers will share actionable insights and real-world examples of how businesses have reduced overhead and improved payroll efficiency.

article thumbnail

How to Succeed in Generic Drug Market Entry

Drug Patent Watch

The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.

103
103
article thumbnail

STAT+: Risky bet by Biogen and UCB on systemic lupus drug appears to pay off, data show

STAT

Biogen and UCB said Tuesday that an experimental drug reduced disease activity and symptoms of systemic lupus, achieving the primary goal of a placebo-controlled Phase 3 study.  Detailed study results were not included in the press release issued by the companies, so how much participants benefited from the drug, called dapirolizumab pegol, won’t be known until data are presented at a medical meeting.

332
332
article thumbnail

mRNA vaccines lead next-generation efforts to combat H5N1 amid global outbreaks: GlobalData

Express Pharma

The H5N1 virus, known for its 50 per cent human case fatality rate, has persisted globally for over two decades, causing thousands of infections. The recent outbreaks, including those affecting US dairy cows, have accelerated the development of next-generation vaccines, with mRNA vaccines stepping into the spotlight, aiming to replicate the success achieved during the COVID-19 pandemic, says GlobalData.

Vaccines 103
article thumbnail

STAT+: Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say

STAT

The GLP-1 drug Wegovy tops the list of medications expected to be included in the next round of Medicare price negotiations, according to a paper in the Journal of Managed Care & Specialty Pharmacy.  Last month, Medicare officials unveiled prices for the first 10 drugs chosen for negotiation. Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs.

article thumbnail

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.

article thumbnail

AstraZeneca India receives CDSCO approval for Durvalumab for specified additional indication

Express Pharma

AstraZeneca Pharma has received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for the below mentioned additional indication, subject to the receipt of related statutory approvals, if any.

article thumbnail

Monday mysteries: An anti-pharma bus and Missouri bird flu updates

STAT

Good morning! Health care challenges like anti-microbial resistance have long created narrative tension for shows like Grey’s Anatomy. But what about an entire musical about it? Ask and ye shall receive. The wheels on the anti-pharma bus … echo GOP talking points A new, dark money group called Americans for Pharma Reform is aiming to bring awareness to what they call bad behavior by the pharmaceutical industry.

275
275
article thumbnail

Reduced Pharmacy First referrals since GP action, poll suggests

The Pharmacist

Almost half of pharmacies in England have seen a reduction in Pharmacy First electronic referrals from GP practices since many GPs began 'working to rule' last month, a poll by Community Pharmacy England (CPE) has suggested. A survey of 4,589 pharmacy premises in England in September has revealed the impact of collective action taken by […] The post Reduced Pharmacy First referrals since GP action, poll suggests appeared first on The Pharmacist.

article thumbnail

STAT+: Pharmalittle: We’re reading about a ‘Bust Big Pharma’ bus tour, few smoking-cessation drugs, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you guessed it — that oh-so familiar routine of online meetings, annoying commutes, and deadlines has predictably returned. But what can you do? The world, such as it is, somehow continues to spin no matter how hard we try to slow it down.

274
274
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

Ind-Ra forecasts weak API prices and volume growth for India in FY25

Express Pharma

India Ratings and Research (Ind-Ra) has projected weak growth in prices and volumes for active pharmaceutical ingredients (APIs) in India for FY25. This is attributed to competition from Chinese imports and exports. Despite this, lower raw material costs have cushioned the effects of price declines. This, combined with forward integration into the formulations business, has resulted in expanded EBITDA margins for pharmaceutical companies.

article thumbnail

The biotech news you need to start the week

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we discuss a bus with anti-pharma messaging that’s traversing the country, we see the FTC file a suit against the three biggest pharmaceutical benefit managers, and more.

article thumbnail

FDA clears RHYTHM AI's new algorithm for atrial fibrillation

pharmaphorum

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

105
105
article thumbnail

STAT+: Will prescription drugs get prior authorization reform?

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. FTC v. the Big 3 Kevin Dietsch/Getty Images The animosity between the Federal Trade Commission and pharmacy benefit managers has reached a boiling point. The FTC sued the nation’s three biggest PBMs last week, accusing them and their secretive group purchasing organizations of creating a “perver

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

FDA clears first drug for Niemann-Pick disease

pharmaphorum

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

115
115
article thumbnail

Active Pharmaceutical Ingredients and Intermediates for the Pharmaceutical Industry

Pharmaceutical Technology

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

98
article thumbnail

J&J tries to push talc bankruptcy over the line once again

pharmaphorum

Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy. Red River Talc LLC was set up specifically to resolve the thousands of claims related to ovarian cancer arising from cosmetic talc litigation, separated from the group's core business and armed with billions of dollars in settlement money to provide compensation to alleged victims.

89
article thumbnail

FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

article thumbnail

Catalytic Droplets leading to faster chemical reactions can bring quicker access to innovative medications

Express Pharma

Researchers have developed catalytic droplets that can lead to a 10-fold increase in speed and efficient catalytic reactions and this is valid below a critical substrate concentration. Such efficient chemical reactions can accelerate drug development, leading to quicker access to innovative medications and potentially lower healthcare costs. Traditionally, chemists have relied on physical and chemical barriers to confine molecules during catalytic reactions.

article thumbnail

Leading Artificial Intelligence (AI) Companies in Pharma

Pharmaceutical Technology

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

94
article thumbnail

Sanofi's Sarclisa gets one up on rival Darzalex in myeloma

pharmaphorum

Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight. The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen alongside bortezomib, lenalidomide, and dexamethasone (VRd), for people who are not eligible for an autologous stem cell transplant (ASCT).

78
article thumbnail

Streamlining IND applications for cell and gene therapy innovations

BioPharma Dive

Regulatory and strategic challenges can delay the delivery of life-changing cell and gene therapies.

98
article thumbnail

EMCrit 384 – The Vascular Guy on Vascular Access

EMCrit Project

All things Vascular Access with the Vascular Guy EMCrit Project by Scott Weingart, MD FCCM.

102
102
article thumbnail

Dr R. N. gupta elected National President of Indian Pharmaceutical Association for 2024-2026 term

Express Pharma

Dr R. N. Gupta has been elected as the National President of the Indian Pharmaceutical Association (IPA) for the term 2024-2026. The IPA is the oldest and largest association of pharmaceutical professionals in India. Dr Gupta’s term will run from October 1, 2024 to 30th September 2026. With nearly five decades of experience in the pharmaceutical industry, academia, and research, Dr Gupta currently serves as an Adjunct Professor at NIPER, Kolkata.