FDA Law Blog: Biosimilars

JUNE 3, 2025

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.

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STAT

JUNE 2, 2025

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 “

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PharmaVoice

JUNE 6, 2025

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

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Chemotherapy Drug Development 147

pharmaphorum

JUNE 3, 2025

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

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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.

BioPharma Dive

JUNE 3, 2025

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

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STAT

JUNE 6, 2025

A monthly treatment from Otsuka reduced by more than half the levels of a toxic protein in the urine of patients with an autoimmune kidney disease. The results presented Friday achieved the interim goal of a Phase 3 study and were numerically superior to study results posted Monday by competitor Vera Therapeutics.  The Otsuka drug, called sibeprenlimab, lowered proteinuria levels by 50.2% after nine months compared to an increase of 2.1% in patients given a placebo.

Drug Development 230

Drug Development 230

Express Pharma

JUNE 6, 2025

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

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The Pharmacist

JUNE 3, 2025

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.

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Online Pharmacies Community Pharmacies 82

STAT

JUNE 5, 2025

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

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Diabetes Drug Development 295

PharmaVoice

JUNE 3, 2025

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.

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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

Communication

Express Pharma

JUNE 6, 2025

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.

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BioPharma Dive

JUNE 1, 2025

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.

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STAT

JUNE 3, 2025

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.

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Drug Pricing Labelling 211

PharmaVoice

JUNE 3, 2025

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

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Express Pharma

JUNE 2, 2025

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.

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Pharmaceutical Manufacturing 75

Pharmaceutical Technology

JUNE 6, 2025

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

Insurance Coverage and Processing 81

Insurance Coverage and Processing Communication Hospitals Drug Development 81

STAT

JUNE 2, 2025

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.

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PharmaVoice

JUNE 2, 2025

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

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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.

FDA Law Blog: Biosimilars

JUNE 2, 2025

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.

Labelling 64

Labelling 64

Pharmafile

JUNE 6, 2025

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.

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Vaccines Hospitals 64

STAT

JUNE 3, 2025

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.

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The Pharmacist

JUNE 6, 2025

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.

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Vaccines Community Pharmacies 60

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.

Pharma Times

JUNE 3, 2025

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

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BioPharma Dive

JUNE 2, 2025

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.

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STAT

JUNE 5, 2025

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.

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Drug Development 290

The Pharmacist

JUNE 6, 2025

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.

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World Pharma News

JUNE 6, 2025

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

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Pharmacy Times

JUNE 2, 2025

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.

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Vaccines 56

STAT

JUNE 2, 2025

The Food and Drug Administration plans to roll out its agency-wide AI tool on Tuesday, weeks ahead of schedule, according to a press release obtained by STAT that provides the most detailed look yet at the technology and how it may be used. Commissioner Marty Makary has hailed the potential of the AI at the FDA, saying it could save employees time and ultimately speed up regulatory reviews.

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BioPharma Dive

MAY 31, 2025

AstraZeneca and Daiichi Sankyo’s drug extended survival by 30% compared to a widely used regimen, further establishing its importance as a second-line treatment option.

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