Tue.May 20, 2025

article thumbnail

New FDA framework on Covid vaccines leaves pediatricians confused and concerned

STAT

A new framework for Covid-19 vaccines announced by Food and Drug Administration leaders Tuesday suggests the agency will no longer approve new Covid vaccines for healthy individuals under 65, including babies, without data from new randomized clinical trials showing their benefit.  The plan — described in a commentary in the New England Journal of Medicine, followed by a live stream on YouTube — created confusion among physicians about what it means for young children.

Vaccines 362
article thumbnail

FDA sets stricter approval standards for COVID vaccines

BioPharma Dive

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Opinion: I study diet and chronic illness. Here’s the uncomfortable truth about seed oils

STAT

For decades, mainstream nutrition guidelines have recommended that Americans replace animal fats like butter or lard with polyunsaturated fats, especially seed oils such as soybean, corn, and sunflower oils. These oils are rich in omega-6 fatty acids and now make up a significant portion of the fat consumed in the standard American diet. But recently, the conversation has shifted.

328
328
article thumbnail

Pharmacies voted most accessible healthcare location

The Pharmacist

Community pharmacy was the most accessible healthcare location for the public last winter, ahead of general practice, dentists and hospital services, polling by YouGov has found. Almost six in 10 people who tried to access community pharmacies last winter found it easy to do so, compared to just four in 10 who could easily access […] The post Pharmacies voted most accessible healthcare location appeared first on The Pharmacist.

article thumbnail

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.

article thumbnail

STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board

STAT

In a notable development, Maryland Gov. Wes Moore signed a bill that will allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies. The move was hailed by consumer advocates who hope the Prescription Drug Affordability Board, which is designed to function much like a state utility commission, will usher in era of lower medicine prices for everyone who lives in Maryland.

article thumbnail

Duck Creek Technologies appoints Tyler Jones as chief marketing officer

Pharmafile

Duck Creek Technologies has appointed Tyler Jones as its new chief marketing officer (CMO). He will lead the companys global marketing strategy, supporting its position as a provider of property and casualty (P&C) insurance software. Jones brings more than two decades of experience at the intersection of insurance, technology and customer experience.

94

More Trending

article thumbnail

Next‑Gen Pharma: AI, ML & Digital Twins Converge at AUTOMA+ 2025

Pharmaceutical Technology

The 5th Pharmaceutical Automation and Digitalisation Congress (AUTOMA+) will gather industry leaders in Vsendorf, Austria on 24-25 November for indepth case studies, practical workshops and highimpact networking designed to accelerate pharmas digital journey.

86
article thumbnail

STAT+: Mental health apps can boost outcomes and lower costs, study finds

STAT

Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps. Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved , but policymakers and insurers have been hesitant to open the path to re

258
258
article thumbnail

What’s Next for Retail Pharmacy: Data, Debate, and Disruption (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: Whats Next for Retail Pharmacy: Data, Debate, and Disruption This event will be broadcast live on: Friday, June 20, 2025 12:00 p.m. to 1:30 p.m. ET Dr. Fein will be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research , and President of 3 Axis Advisors.

article thumbnail

Blunt Rochester presses RFK Jr. on CDC acting director

STAT

Sen. Lisa Blunt Rochester has written a stinging letter to Health Secretary Robert F. Kennedy Jr. demanding that he clarify whether the Centers for Disease Control and Prevention has an acting director. In her three-page missive, Blunt Rochester suggested that Matthew Buzzelli, the person Kennedy said was the CDC’s acting director, cannot hold the role because he isn’t qualified under the federal Vacancies Act.

223
223
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

Barentz acquires Fengli, China, aims to strengthen market presence

Express Pharma

Barentz, a specialty ingredients solutions provider, has entered into exclusive discussions to acquire 100 per cent equity of Fengli Group, a specialty chemicals distributor for pharmaceutical excipients and active ingredients in China. Established in 1996 and headquartered in Beijing, Fengli Group comprises a team of over 100 experienced professionals across five locations in mainland China.

65
article thumbnail

STAT+: Pharmalittle: We’re reading about FDA eyeing PDUFA changes, compounded weight loss drugs, and more

STAT

Top of the morning to you, and a fine one it is. Clear, blue skies and comfortable breezes are enveloping the Pharmalot campus, where the short person is sleeping in and the official mascots are threatening local cats to keep their distance. As for us, we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today is pecan bourbon) and foraging for items of interest.

article thumbnail

Countries formally adopt WHO’s Pandemic Agreement for future pandemics

Pharmaceutical Technology

The agreement will see international initiatives to fight the next pandemic, but funding remains the weak link.

59
article thumbnail

Regeneron makes another deal — This one about AI

STAT

Y ou’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Good morning health tech readers!

177
177
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

O'Shaughnessy says UK clinical trials sector is on the mend

pharmaphorum

After losing ground in commercial clinical trials in recent years, the UK has now turned a corner and is once again taking a "global lead"

59
article thumbnail

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

BioPharma Dive

Tourmaline Bio disclosed results for a potential rival to a Novo Nordisk drug. Elsewhere, data emerged for a psychedelic and CRISPR Therapeutics expanded its toolkit.

57
article thumbnail

How to Identify Profitable Generic Drug Opportunities Using Patent Expiration Data

Drug Patent Watch

"Patent Expiration: The Secret to Unlocking a $1 Trillion Market Opportunity As the pharmaceutical industry continues to shift towards generics, one thing is clear: the next big winners will be those who can identify and capitalize on the impending patent expirations of blockbuster drugs. According to our analysis of patent expiration data, the next 5 years will see the loss of exclusivity for over 200 top-selling medications, with a combined market value of over $1 trillion.

61
article thumbnail

​What wealthy investors want—and what it means for your next deal

Fuld & Company Blog

New research reveals that financial institutions are deep into digital transformationbut data strategy, AI implementation, and legacy systems are proving to be the fault lines. From cloud infrastructure to GenAI, and digital assets to cybersecurity, financial firms are investing heavily to modernize their operations and stay competitive. Yet a new study shows that even as budgets rise and digital ambitions grow, most institutions are still struggling to align strategy with execution.

52
article thumbnail

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.

article thumbnail

Pharmaceutical Technology Excellence Awards 2025: Novotech 

Pharmaceutical Technology

Novotech is a winner in the Diversity, Research and Development, and Marketing categories in the 2025 Pharmaceutical technology Excellence Awards.

59
article thumbnail

​What wealthy investors want—and what it means for your next deal 

Fuld & Company Blog

Data from Avaloq reveals shifting investor expectations, growing tech dissatisfaction among wealth managers, and opportunities for platform modernizationinsights that matter to anyone investing in or advising financial firms. The Avaloq Wealth Insights 2024 report, developed in partnership with Phronesis Partners , is based on surveys with 3,000+ investors and over 300 wealth professionals across Europe, Asia, and the Middle East, reveals major disconnects between what investors expect and how

article thumbnail

HHS sets “most favoured nation” pricing targets for drug makers

Pharmaceutical Technology

Drug manufacturers will now have to commit to the new pricing model to avoid regulatory action in the US.

52
article thumbnail

Real-world evidence in CNS research: Past, present, future

pharmaphorum

Patient-centric, large-scale real-world studies, which use data collected outside the system of controlled clinical trials, can and have already been delivered successfully. The tools, systems, and processes are available today, and modern technology has made it much easier to successfully run a real-world CNS study.

52
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

ATS 2025: Anti–IL-5 therapy cuts exacerbations in coexisting COPD and asthma patients

Pharmaceutical Technology

An ATS 2025 session presented data showing that antiIL-5 biologics significantly cut exacerbations in coexisting asthma and COPD patients.

52
article thumbnail

New real-world data guidance could accelerate drug approvals

European Pharmaceutical Review

On International Clinical Trials Day 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) has declared there has been major progress in the delivery of regulatory framework to make UK clinical trials more efficient and flexible. Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades.

52
article thumbnail

ATS 2025: ETI-linked mucus clearance tied to lung function gains in paediatric CF

Pharmaceutical Technology

Data presented at ATS 2025 showed that lung improvement in paediatric cystic fibrosis (CF) patients receiving ETI therapy is driven by regional mucus plug clearance.

52
article thumbnail

FDA grants fast track status to Zai Lab’s lung cancer treatment

Pharmaceutical Business Review

This ADC, which is currently under assessment in a global Phase Ia/IIb trial, has secured orphan drug designation from the agency for SCLC. According to the company, SCLC represents one of the most lethal solid tumours, making up about 15% of the 2.5 million patients diagnosed with lung cancer globally each year. Notably, two-thirds of all SCLC individuals are said to be diagnosed at an extensive stage.

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

UK's long-term R&D investment policy welcomed

pharmaphorum

The decision by the UK to set new 10-year budgets for public R&D funding has received a positive response from academia and the pharma industry

55
article thumbnail

ATS 2025: Real-world data supports Trikafta as gold standard in long-term CF care

Pharmaceutical Technology

The published long-term data suggests that the treatment could maintain its dominant position in the CF market.

52
article thumbnail

Triple-Combination Therapy Met Primary End Point in Phase 3 Trials, Providing Treatment for Individuals With Asthma

Pharmacy Times

A new triple-combination therapy shows promise in improving asthma management, offering hope for millions with uncontrolled symptoms.

49
article thumbnail

Skye and Arecor to develop higher formulation of CB1 inhibitor

Pharmaceutical Technology

Skye has entered a partnership with Arecor aimed at developing a higher formulation of the formers obesity candidate, nimacimab.

52
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.