FDA Law Blog: Biosimilars

MAY 19, 2025

By Larry K. Houck Last month the U.S. Attorneys Office for the Northern District of Illinois announced that Walgreens agreed to pay up to $350,000,000 to resolve allegations that its pharmacies illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the federal Controlled Substances Act, and sought payment for filling many of those prescriptions by federal health care programs, violating the False Claims Act.

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STAT

MAY 20, 2025

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.

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PharmaVoice

MAY 19, 2025

HHS issued guidance for the third cycle, teeing up another 15 drugs to be selected by early next year.

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BioPharma Dive

MAY 20, 2025

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.

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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.

pharmaphorum

MAY 22, 2025

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity

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STAT

MAY 20, 2025

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.

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The Guardian - Pharmaceutical Industry

MAY 21, 2025

Brand shifts away from dieting towards weight-loss injections after filing for bankruptcy in the US WeightWatchers is teaming up with a provider of weight-loss drugs such as Wegovy and Mounjaro, in a seismic shift for the brand away from a focus on dieting as it tries to turn around its struggling business. WeightWatchers, which has promoted a non-medical, points-based approach to food intake since its creation in the 1960s , has announced a strategic partnership in the UK with CheqUp, a provide

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The Pharmacist

MAY 20, 2025

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.

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STAT

MAY 20, 2025

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.

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Drug Pricing 265

PharmaVoice

MAY 19, 2025

With policies in flux, companies seek to be proactive and understand their supply chain.

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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

Pharmafile

MAY 20, 2025

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.

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Pharma Times

MAY 19, 2025

Regulator confirms safety and efficacy of new treatment option for patient

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STAT

MAY 20, 2025

Of the seven health tech companies that met with the government’s most powerful health official on Monday, all but one had something in common: Financial backing from one of Silicon Valley’s top venture capital firms. In a post on the social media platform X, the Department of Health and Human Services announced that health secretary Robert F.

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PharmaVoice

MAY 22, 2025

Turnover of the top execs at pharma giants like J&J, AbbVie and Merck in the last few years illustrates the seismic industry shifts that often accompany leadership changes.

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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.

pharmaphorum

MAY 22, 2025

In a signal of a return to investor appetite for digital health stocks, Hinge Health has raised an impressive $437 million in an IPO

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Pharmaceutical Technology

MAY 20, 2025

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.

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STAT

MAY 20, 2025

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

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Drug Patent Watch

MAY 20, 2025

"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.

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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.

BioPharma Dive

MAY 19, 2025

The biotech, which has for years invested in genetics research, plans to acquire "substantially all" of testing firm 23andMe's assets for $256 million.

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The Guardian - Pharmaceutical Industry

MAY 19, 2025

Drugmaker Regeneron Pharmaceuticals will buy the genetic testing firm through a bankruptcy auction The drugmaker Regeneron Pharmaceuticals will buy the genetic testing firm 23andMe Holding for $256m through a bankruptcy auction, the companies said on Monday. Regeneron said it will comply with 23andMes privacy policies and applicable laws with respect to the use of customer data and that it is ready to detail its intended use of the data to a court-appointed overseer.

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STAT

MAY 19, 2025

Molecular biologist Chiara Masnovo spent weeks filling out an application for a research fellowship earlier this year — taking it over the finish line as she was 38 weeks pregnant and starting a new job.  The chance of getting this fellowship was well worth the toil. The Hanna Gray fellowship, created by the Howard Hughes Medical institute, supports postdoctoral researchers from diverse backgrounds in their transition to heading their own labs.

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Express Pharma

MAY 21, 2025

Senores Pharmaceuticals, through its wholly-owned subsidiary Senores Pharmaceuticals, USA, has signed an agreement to acquire the USFDA-approved Abbreviated New Drug Application (ANDA) for Enalapril Maleate Tablets 2.5mg, 5mg, 10mg and 20mg from Wockhardt. Enalapril is indicated as a treatment of hypertension, heart failure, and asymptomatic left ventricular dysfunction.

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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.

Drug Channels

MAY 20, 2025

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.

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Pharmaceutical Manufacturing Drug Pricing Hospitals 75

pharmaphorum

MAY 21, 2025

BioNTech has said it will commit up to 1bn in investment in the UK over the next decade, in what has been described as a "template" for the sector

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STAT

MAY 20, 2025

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.

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Pharmaceutical Technology

MAY 20, 2025

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

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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.

Express Pharma

MAY 22, 2025

As clinical trial designs become more complex, the requirements for participation from both a patient and trial site perspective have also evolved. With compliance being a factor for success, sponsors are being pushed to rethink how they manage and capture clinical outcome assessments (COAs). Speed, scale and precision are no longer simply nice to have, they are the foundation of a successful study.

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Documentation 52

pharmaphorum

MAY 19, 2025

The revitalisation of GSK's blood cancer therapy Blenrep continues with a second approval, in Japan, as a second-line treatment for multiple myeloma

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STAT

MAY 19, 2025

This is the online version of STAT’s email newsletter Health Care Inc., delivered to your inbox every Monday.  Sign up here. I’ve always been skeptical of virtual reality headsets, and it appears my skepticism has been justified. Tell me what’s going on in your reality, virtually: bob.herman@statnews.com or bobjherman.09 on Signal.

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Hospitals 257

The Pharmacist

MAY 22, 2025

Pharmacies have been advised that the brand Nystan 100,000units/ml oral suspension (ready mixed) (Vygoris Ltd)30 ml has been discontinued. The branded oral suspension, used for oral thrush, is no longer available for pharmacies to order and instead a generic Nystatin 100,000units/ml oral suspension should be ordered from wholesalers. The discontinuation raises potential price issues, as […] The post Nystan oral suspension discontinued appeared first on The Pharmacist.

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