Sat.May 31, 2025 - Fri.Jun 06, 2025

article thumbnail

Two “Unresolvable” Prescribing/Dispensing Red Flags Unfurled

FDA Law Blog: Biosimilars

By Larry K. Houck We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice. Press Release, Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S.

article thumbnail

Opinion: MAHA kids’ health report misinforms about tonsillectomies and ear tubes

STAT

The Make America Healthy Again commission’s recent report on children’s health has received a lot of attention for its citation errors and focus on ultra-processed foods, smartphones, and stimulant use. But the less-discussed part on “overmedicalization” of American children stood out to us. While the report mentions surgical care only briefly, it identifies two common procedures, adenotonsillectomy and tympanostomy tube (ear tube) placement, as surgeries that “

311
311
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

FDA’s Elsa AI is here, and the industry has questions

PharmaVoice

The agency has provided few details about its AI pilot as it makes moves on its “aggressive timeline” for rollout.

260
260
article thumbnail

Amid staff cuts, FDA looks to AI to 'optimise' reviews

pharmaphorum

The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews

89
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

Bayer drug could ease side effects of common breast cancer treatment, detailed data show

BioPharma Dive

Elinzanetant proved effective for managing disruptive vasomotor symptoms in women on endocrine therapy, supporting a Bayer application for approval.

84

More Trending

article thumbnail

With ADCs on the rise, drugmakers embrace a new oncology pillar

PharmaVoice

Skip to main content CONTINUE TO SITE ➞ Dont miss the most important voices in pharma Let PharmaVoices free newsletter keep you informed on what industry leaders are saying, straight from your inbox. By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Voices Q&A Profiles Biotech Spotlight First 90 Days Opinions Topics Biotech Commercialization Leadership Manufacturing Patient Pharma Policy & Regulation Research & Deve

article thumbnail

PureTech’s LYT-100 holds potential to expand treatment options for idiopathic pulmonary fibrosis: GlobalData

Express Pharma

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterised by scarring of lung tissue, leading to impaired lung function and respiratory symptoms. The emerging therapies aim to address unmet needs in IPF management by targeting specific fibrotic pathways. Therapies such as LYT-100 by PureTech, currently in Phase IIb clinical trials, show promise in potentially offering improved efficacy and safety profiles, as it is a deuterated form of pirfenidone, which allows it

90
article thumbnail

Halt to new distance selling pharmacies

The Pharmacist

No new distance selling pharmacies (DSPs) will be allowed as of 23 June 2025, following regulatory changes within the community pharmacy sector. Changes to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 laid before Parliament on Monday will mean no new applications for online pharmacies can be accepted or permitted from around […] The post Halt to new distance selling pharmacies appeared first on The Pharmacist.

article thumbnail

GLP-1 drugs may be linked to elevated risk of serious eye disease, study finds

STAT

People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications. The research, published Thursday in JAMA Ophthalmology , found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were no

Diabetes 302
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

Sanofi to acquire Blueprint for up to $9.5B

PharmaVoice

The pharma giant is betting that Blueprint, whose research revolves around a certain kind of tyrosine kinase, will be a boost to its immunology business.

130
130
article thumbnail

Supriya Lifescience’s Saloni Wagh and Shivani Wagh named in 2025 Candere Hurun India Women Leaders List

Express Pharma

Dr Saloni Wagh, Managing Director, and Shivani Wagh, Joint Managing Director of Supriya Lifescience, have been named in the 2025 Candere Hurun India Women Leaders List. The list, compiled by Candere and Hurun India, features 95 women leaders who have demonstrated business leadership and contributed to the Indian economy. The 2025 edition of the list follows the theme “Celebrating Women Creating Opportunities.

87
article thumbnail

RFK Jr looks to alter rare disease regulation by fast-tracking drug approvals

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

article thumbnail

STAT+: Pharmalittle: We’re reading about a FDA AI tool, mRNA as a political reject, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and pleasant breezes are wafting across the Pharmalot campus, where the official mascots are foraging for their breakfast and rousing the neighbors. 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 banana split, which is fast becoming a trusty favorite.

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

How leading oncology drugmakers set the stage for future advances

PharmaVoice

Drugmakers like J&J and Astellas are looking beyond today’s cancer treatments for the windows of opportunity decades down the road.

130
130
article thumbnail

Cipla appoints Prabhakaran Nair as Global Chief Manufacturing Officer

Express Pharma

Cipla has announced the appointment of Prabhakaran Balakrishnan Nair as its Global Chief Manufacturing Officer, effective July, 1, 2025. Nair will also join as a designated Senior Management Personnel. He is currently serving as the Chief of Quality at Ciplas Indore facility. With more than 34 years of experience in pharmaceutical manufacturing and quality, Nair has held leadership roles focused on regulatory adherence, operational processes, and technology-led quality systems.

article thumbnail

AstraZeneca drug could help keep a common breast cancer at bay

BioPharma Dive

Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.

109
109
article thumbnail

STAT+: A cautious culture cost Novo Nordisk its lead in the obesity drug race, former employees say

STAT

In the late 2010s, scientists at the Danish drugmaker Novo Nordisk developed a new weekly obesity treatment that targeted three hormones at once. In mice studies , the drug, which activated receptors of the GLP-1, GIP, and glucagon hormones, caused notable weight loss. But Novo shelved the therapy. The company was concerned about potential side effects of targeting glucagon, like increasing blood sugar and heart rate.

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

COVID’s remaining biotech contenders navigate a dwindling market

PharmaVoice

With policy and funding evolving, companies are being forced to rethink strategies.

130
130
article thumbnail

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law Blog: Biosimilars

By Steven J. Gonzalez & Allyson B. Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. This means the District Court decision stands, with no further right of appeal, and the LDT Rule remains vacated in its entirety.

article thumbnail

Osivax reaches key milestone in phase 2a trial for broad-spectrum flu vaccine

Pharmafile

Osivax has announced the completion of patient visits in its phase 2a trial evaluating a booster dose of OVX836, a broad-spectrum influenza A vaccine candidate. The final results from the trial are expected in the second half of 2025. Conducted at the centre for vaccinology (CEVAC), Ghent University Hospital, Belgium, the trial investigated the safety […] The post Osivax reaches key milestone in phase 2a trial for broad-spectrum flu vaccine appeared first on Pharmafile.

article thumbnail

Anti-LGBTQ+ incidents related to health care have increased

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! It’s June 3 — a significant day in the fictional “Gilmore Girls” town of Stars Hollow, and just another day of June/late spring/Pride for those of us in the real world. But there’s plenty of news today, so let’s get into it.

213
213
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

Pharmacy flu vaccination ‘walk-in finder’ to launch later this year

The Pharmacist

A flu vaccination walk-in finder that will help patients easily look up where they can walk into a community pharmacy to have a vaccine is to launch later this year, NHS England has announced. In its new urgent and emergency care plan 2025/26, NHS England has unveiled plans for a ‘flu walk-in finder’ in a […] The post Pharmacy flu vaccination ‘walk-in finder’ to launch later this year appeared first on The Pharmacist.

article thumbnail

ISTH: new data highlight innovation from Sanofi's pipeline in rare diseases

World Pharma News

New data from 18 abstracts, including five oral presentations, will be presented at the 33rd congress of the International Society on Thrombosis and Haemostasis (ISTH) in Washington D.C., US from June 21 to 25, 2025, highlighting Sanofi as a leader in hemophilia committed to rare blood diseases. Data to be presented expand on the potential of rilzabrutinib to address the underlying immune dysregulation of immune thrombocytopenia (ITP) and strengthen Sanofi as a leader in hemophilia with ALTUVIII

Immunity 104
article thumbnail

PharmaTimes Clinical Researcher of the Year – The Americas

Pharma Times

Enter The 2025 PharmaTimes Clinical Researcher of the Year The Americas!

80
article thumbnail

Ingredient up to 13,000 times sweeter than sugar lurks in vapes popular with teens, study shows

STAT

Ice cream, lip gloss, and sparkling water are just a few of the products that can contain neotame — an artificial sweetener that’s 7,000-13,000 times sweeter than sugar. Now researchers have found it’s also in many flavored disposable e-cigarettes, which they warn gives them extra appeal to teens and kids. The study , published Monday in JAMA, found neotame in all 11 of the popular disposable vape brands it tested, including Elf Bar, Breeze, and Mr.

295
295
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

Call to expand England’s Pharmacy First service in line with Scotland

The Pharmacist

Almost 20 million patients a year could be treated in England by expanding Pharmacy First to a similar service to Scotland, according to analysis from the National Pharmacy Association (NPA). A report published by Public Health Scotland in May found that 35% of the Scottish population (1,895,836) used Pharmacy First Scotland in the most recent […] The post Call to expand England’s Pharmacy First service in line with Scotland appeared first on The Pharmacist.

59
article thumbnail

Bristol Myers allies with BioNTech on bispecific cancer drug

BioPharma Dive

The oncology giant will pay $1.5 billion to co-develop a BioNTech drug that targets the proteins PD1 and VEGF, following Merck, and Pfizer into what’s become a competitive development race.

114
114
article thumbnail

CDC Clarifies That Kids May Receive COVID-19 Vaccine Through Shared Clinical Decision-Making

Pharmacy Times

The CDC has updated its COVID-19 vaccine guidance for children and pregnant individuals, sparking a debate among health experts and concerns over insurance coverage.